1,1-dimethylbiguanide hydrochloride

1,1-dimethylbiguanide hydrochloride - Names and Identifiers

Name	Metformin HCL
Synonyms	DIABEX diformin GLUCOPHAGE diabefagos DIABETOSAN Metformin HCL Metformin Hydrochloride dimethylbiguanidehydrochloride Dimethyldiguanidinehydrochloride 1,1-dimethyl-biguanidhydrochloride 1,1-dimethylbiguanide hydrochloride
CAS	1115-70-4 15537-72-1
EINECS	214-230-6
InChI	InChI=1/C4H11N5.ClH/c1-9(2)4(7)8-3(5)6;/h1-2H3,(H5,5,6,7,8);1H
InChIKey	OETHQSJEHLVLGH-UHFFFAOYSA-N

1,1-dimethylbiguanide hydrochloride - Physico-chemical Properties

Molecular Formula	C4H12ClN5
Molar Mass	165.62
Density	1.36[at 20℃]
Melting Point	223-226°C(lit.)
Boling Point	224.1°C at 760 mmHg
Flash Point	9℃
Water Solubility	Soluble in water (50 mg/ml), ethanol, and DMSO (50 mM).
Solubility	Easily soluble in water, dissolved in methanol, slightly soluble in ethanol, insoluble in ether and chloroform.
Vapor Presure	0.001Pa at 25℃
Appearance	Crystalline solid
Color	White
Maximum wavelength(λmax)	['233nm(H2O)(lit.)']
Merck	14,5938
pKa	12.4[at 20 ℃]
Storage Condition	2-8°C
Stability	Stable for 2 years from date of purchase as supplied. Solutions in DMSO or distilled water may be stored at -20° for up to 2 months.
MDL	MFCD00012582
Physical and Chemical Properties	White Crystal or crystalline powder. Melting point 232 °c (218-220 °c). Soluble in water, dissolved in methanol, slightly soluble in ethanol, insoluble in ether and chloroform. Odorless and bitter.
Use	Hypoglycemic agents, for non-insulin-dependent diabetes mellitus

1,1-dimethylbiguanide hydrochloride - Risk and Safety

Risk Codes	R22 - Harmful if swallowed R36/38 - Irritating to eyes and skin. R39/23/24/25 - R23/24/25 - Toxic by inhalation, in contact with skin and if swallowed. R11 - Highly Flammable
Safety Description	S26 - In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. S36 - Wear suitable protective clothing. S45 - In case of accident or if you feel unwell, seek medical advice immediately (show the label whenever possible.) S36/37 - Wear suitable protective clothing and gloves. S16 - Keep away from sources of ignition. S7 - Keep container tightly closed.
UN IDs	UN1230 - class 3 - PG 2 - Methanol, solution
WGK Germany	3
RTECS	DU1800000
HS Code	29252900
Toxicity	LD50 in rats (mg/kg): 1000 orally, 300 s.c. (Rx Bulletin)

1,1-dimethylbiguanide hydrochloride - Reference

Reference

1. Liu Chao Gao Huijie Yang Qiangqiang et al. Anti-inflammatory effect of metformin on lipopolysaccharide-induced inflammatory reaction mice [J]. Basic medicine and clinical 2019(9).
2. Liu Changhe Fu Qian Li Bin Pan Yilong Liu Zhen Li Xiaodong. Metformin regulates the signaling pathway of small conductance calcium-activated potassium channel protein expression in the atrium of diabetic rats [J]. Chinese Journal of Elderly Cardiovascular and Cerebrovascular Diseases 2020 22(01):70-74.
3. Wang Xiaotong, Lin Haixiong, Guo Ailin, Li Zhicheng, Qiu Shulin, Li Mingzhu, Zhang Ren. Effects of Polygonatum odoratum and Its Polysaccharides on Blood Glucose, Blood Lipid and NGF mRNA Expression in Sciatic Nerve of Type 2 Diabetic Rats [J]. Chinese Journal of Traditional Chinese Medicine, 2017,35(05):1177-1180 1351.
4. Gu Yuyin, Ding Shumei, Sun Cuicui, et al. Study on the Effect of Bai Fengcai on Glucose Tolerance [J]. Chinese Animal Husbandry and Veterinary Medicine, 2017, 44(005):1547-1551.
5. Yang Huanjie, Zhang Haibo, Xu Rui, Gao Huijing, Yuan Yuan, Zhao Jun. Determination of Metformin Hydrochloride in Human Plasma and Urine by Ion Exchange Chromatography [J]. Chinese Journal of Clinical Pharmacology, 2017,33(09):821-824.
6. Yang Yanhua, Lin Sujing, Liu Xijing, Du Bin. Effects of Sonchus longicus extract on glucose metabolism in insulin resistance HepG2 cells [J]. Journal of Shenzhen Vocational and Technical College (Phase 1):45-49.
7. Li Dandan, Liu Jiajia, Wu Yuhong, etc. Effects of Astragalus Polysaccharide Combined with Metformin on Glucose and Lipid Metabolism in Liver of Aging Type 2 Diabetes Model Mice [J]. Chinese Journal of Traditional Chinese Medicine Information, 2019, 26(02):47-51.
8. Liu Jiajia, Li Dandan, Zhao Yi, Wu Yuhong, Wang Jing. Effect of astragalus polysaccharide combined with metformin on liver mRNA expression profile and functional analysis of aging diabetic mice [J]. Shi Zhen Chinese Medicine, 2020,31(05):1043-1046.
9. Cao Yu, Xu Lu, Li Kaifeng, Zhu Hanchao, Li Yao, Li Jie, Duan Weixun, Wang Siwang, Tang Haifeng. Protective effect of mulberry leaf extract on myocardium of diabetic mice [J]. Heart magazine, 2021,33(01):17-23.
10. Song, Xing-Bo, et al. "Assessment of metformin, nicotine, caffeine, and methamphetamine use during Chinese public holidays." Chemosphere 258 (2020): 127354.https://doi.org/10.1016/j.chemosphere. 2020.127354
11. Yao, Ye, et al. "Berberine alleviates type 2 diabetic symptoms by altering gut microbiota and reducing aromatic amino acids." Biomedicine & Pharmacotherapy 131 (2020): 110669.https://doi.org/10.1016/j.biopha. 2020.110669
12. [IF=8.679] Dali Tong et al."Metformin inhibits castration-induced EMT in prostate cancer by repressing COX2/PGE2/STAT3 axis."Cancer Lett. 2017 Mar;389:23
13. [IF=3.061] Wenhua Kuang et al."Ligustrazine modulates renal cysteine biosynthesis in rats exposed to cadmium."Environ Toxicol Phar. 2017 Sep;54:125
14. [IF=9.229] Wei Xiong et al."Metformin Liposome-Mediated PD-L1 Downregulation for Amplifying the Photodynamic Immunotherapy Efficacy."Acs Appl Mater Inter. 2021;13(7):8026-8041
15. [IF=7.963] Yang Xiao et al."Assessing the trend of diabetes mellitus by analyzing metformin as a biomarker in wastewater."Sci Total Environ. 2019 Oct;688:281
16. [IF=7.691] Xizhan Xu et al."Antidiabetic Effects of Gegen Qinlian Decoction via the Gut Microbiota Are Attributable to Its Key Ingredient Berberine."Genom Proteom Bioinf. 2020 Dec;18:721
17. [IF=7.086] Xing-Bo Song et al."Assessment of metformin, nicotine, caffeine, and methamphetamine use during Chinese public holidays."Chemosphere. 2020 Nov;258:127354
18. [IF=3.612] Jianhong Dang et al."Roles of metformin-mediated girdin expression in metastasis of epithelial ovarian cancer."Cell Biol Int. 2021 May;45(5):1030-1037
19. [IF=6.576] Xinting Shen et al."Polyphenol Extracts From Germinated Mung Beans Can Improve Type 2 Diabetes in Mice by Regulating Intestinal Microflora and Inhibiting Inflammation."Front Nutr. 2022; 9: 846409
20. [IF=4.451] Jie Gao et al."Ferulic acid targets ACSL1 to ameliorate lipid metabolic disorders in db/db mice."J Funct Foods. 2022 Apr;91:105009

1,1-dimethylbiguanide hydrochloride - Metformin Hydrochloride And Glibenclamide Tablets(Ⅰ) (I)

Authoritative Data Verified Data

This product shall contain metformin hydrochloride (C4H11N 5 • HC1) at 95.0%-105.0% of the labeled amount and glibenclamide (C23H28C1N3OsS) at 90.0%-110.0% of the labeled amount.

trait

This product is white to off-white or film-coated, white or off-white after removal of the coating.

identification

take an appropriate amount of fine powder of this product (about 50mg of metformin hydrochloride), add 10ml of water, shake to dissolve metformin hydrochloride, filter, and take 2ml of continued filtrate, add 10% sodium nitroprusside ferricyanide solution-potassium ferricyanide test solution-10% sodium hydroxide solution (equal volume mixing, 2 0 minutes to use) 10ml,3 minutes solution is red.
the sample solution for the content determination of metformin hydrochloride was measured by ultraviolet-visible spectrophotometry (General 0401), and the maximum absorption was found at a wavelength of 233mn.
in the chromatogram recorded under the content determination of glibenclamide, the retention time of the main peak of the test solution should be consistent with the retention time of the main peak of the control solution.
The filtrate under identification (1) was taken to show chloride to identify the reaction of (1) (General 0301).

examination

Related substances take 30 tablets of this product, remove the coating of the coated tablets, grind them finely, weigh the amount (about 50mg equivalent to metformin hydrochloride), put them in a 100ml measuring flask, and add an appropriate amount of mobile phase, ultrasonic about 5 minutes to dissolve metformin hydrochloride, cool, dilute to scale with mobile phase, shake, filter, and take the filtrate as the test solution, the mobile phase was added for dissolution and quantitative dilution to make about 0.1 M g of the solution was used as the dicyandiamide reference solution; An appropriate amount of the melamine reference was additionally taken, dissolved by adding a mobile phase, and diluted to prepare a solution containing about 0.2mg in 1ml as the melamine solution. 1ml of each of the above three Solutions was accurately measured and placed in the same 200ml measuring flask, diluted to the scale with mobile phase, and shaken to serve as a control solution. According to high performance liquid chromatography (General rule 0512) test, using sulfonic acid group cation exchange bonded silica gel as filler, with ammonium dihydrogen phosphate solution (take ammonium dihydrogen phosphate 17g, add water 1000ml to dissolve, using phosphoric acid to adjust the pH value to 3.0) as mobile phase, the detection wavelength is 218nm, the number of theoretical plate is not less than 5000 according to the dicyandiamide peak, and the separation degree of metformin peak and melamine peak should be greater than 10.0. 10 u1 of the control solution and 10 u1 of the test solution were respectively injected into the human liquid chromatograph, and the chromatogram was recorded to twice the retention time of the chromatographic peak of metformin. If the chromatogram of the test solution has a shuanglingamine peak, the peak area shall be calculated according to the external standard method, and 0.04% of the labeled amount of metformin hydrochloride shall not be passed. If there are other impurity peaks, the Peak area of the individual impurity peak (retention time after the dicyandiamide peak) should not be greater than 0 .4 times (0.2% ) , the other each impurity peak (retention time after the dicyandiamide peak) Peak area of the sum of not more than 2 times the control solution of metformin peak area (1.0%).
impurity I and impurity II: Weigh an appropriate amount of fine powder under the items of related substances (about 12.5mg of Glibenclamide), put it in a 25ml measuring flask, and add 16ml of methanol, sonicate for about 20 minutes and shake to dissolve glibenclamide, let it cool, dilute to scale with ammonium dihydrogen phosphate solution (take ammonium dihydrogen phosphate 1.725g, add water 300ml to dissolve, adjust pH to 3.5±0.05 with phosphoric acid), shake well, after centrifugation, the supernatant was filtered, and the filtrate was continued as the test solution. 4-[2-(5-chloro-2-methoxybenzamide)-ethyl]-benzenesulfonamide (impurity I) with 4-[2-(5-chloro-2-methoxybenzamide)-ethyl]-benzenesulfonylamino-carboxylic acid ethyl ester (impurity II) reference product each appropriate amount, precision weighing, methanol was added for dissolution and quantitative dilution to make about 0.% of each of impurity I and impurity II per 1 ml. 3mg of the solution, take 1 ml precision, 100ml flask, diluted with mobile phase to the scale, shake, as a control solution. According to the chromatographic conditions under the content determination of glibenclamide, take the reference solution and the sample solution of 20 u1, respectively, and inject the human liquid chromatograph, the chromatogram was recorded to 2 times the peak retention time of glibenclamide. If there are chromatographic peaks corresponding to impurity I and impurity II in the reference solution in the chromatogram of the test solution, the peak area shall be calculated according to the external standard method, and shall not exceed 0.6%.
Content uniformity glibenclamide take 1 tablet of this product, put it in 25ml measuring flask (glibenclamide 1.25mg specification) or 50ml measuring flask (glibenclamide 2.5mg specification), and add an appropriate amount of methanol, glibenclamide was dissolved by ultrasound for about 20 minutes, allowed to cool, diluted to the scale with mobile phase, shaken, filtered, and the filtrate was taken as the test solution. According to the content determination of glibenclamide under the method of determination of glibenclamide content, should comply with the provisions (General 0941).
dissolution of this product, according to the dissolution and release determination method (General 0931 third method), with 0. 02% Tris (hydroxymethyl) aminomethane solution ml as dissolution medium, rotating at 75 rpm, operated according to law. After 45 minutes, 10ml of the solution was taken, filtered, and the filtrate was ready for use.
metformin hydrochloride the appropriate amount of the above filtrate is accurately measured and diluted with dissolution medium to prepare a solution containing 5ug of metformin hydrochloride (calculated according to the labeled amount) per 1 ml as a test solution, according to UV-Vis spectrophotometry (General rule 0401), measure absorbance at 233nm wavelength, and accurately weigh appropriate amount of metformin hydrochloride reference substance, the dissolution medium was added and dissolved and quantitatively diluted to prepare a solution containing about 5ug per 1 ml as a reference solution, which was determined by the same method. The amount of metformin hydrochloride dissolved in each tablet was calculated. The limit is 80% of the labeled amount and shall be in accordance with the provisions.
glibenclamide the above filtrate was taken as a test solution. Weigh about 12.5mg of glibenclamide reference substance accurately, put it in a 25ml measuring flask, add an appropriate amount of methanol, sonicate for about 20 minutes to dissolve glibenclamide, let it cool, dilute it to scale with methanol, shake it well, take 1ml and 100mL volumetric flask (glibenclamide 1. 25mg specification) or 50ml flask (glyburide 2.5mg specification), diluted with dissolution medium to the scale, shake, as a reference solution. According to the chromatographic conditions under the content determination of glibenclamide, the detection wavelength is changed to 225nm, and 20ul of the test solution and the reference solution are accurately measured, respectively, and the human liquid chromatograph is injected and the chromatogram is recorded. The dissolution amount of glibenclamide in each tablet was calculated by peak area according to external standard method. The limit is 75% of the labeled amount and shall be in accordance with the provisions.
others shall be in accordance with the relevant provisions under the item of tablets (General rule 0101).

Content determination

metformin hydrochloride 20 tablets, precision weighing, fine grinding, precision weighing an appropriate amount (equivalent to metformin hydrochloride 50mg), put in a 100ml measuring flask, add an appropriate amount of water, ultrasonic for about 5 minutes to dissolve metformin hydrochloride, let it cool, dilute to the scale with water, shake well, filter, accurately take lml filtrate, put it in a 100ml measuring flask, dilute to the scale with water, shake well, measure absorbance at the wavelength of 233mn by UV-Vis spectrophotometry (General rule 0401), and accurately weigh appropriate amount of metformin hydrochloride reference substance, water was added to dissolve and diluted to prepare a solution containing about 5ug per 1 ml, which was determined and calculated by the same method as the reference solution.
glibenclamide was measured by high performance liquid chromatography (General 0512). (1) chromatographic conditions and system applicability test with eighteen alkyl silane bonded silica gel as filler; Methanol-ammonium dihydrogen phosphate solution (take ammonium dihydrogen phosphate 1.725g, add water 300ml to dissolve, adjust the pH value to 3.5±0.05 with phosphoric acid)(50: 30) as mobile phase; The detection wavelength was 300mn. The reference solution 20u1 under impurity I and impurity II inspection items is injected into the liquid chromatograph, and the chromatogram is recorded. The separation degree of impurity I peak and impurity II peak shall meet the requirements. (2) precise weighing the appropriate amount of fine powder (about 5mg of Glibenclamide) under the content determination item of metformin hydrochloride, placing it in a 100ml measuring flask, adding the appropriate amount of methanol, sonicating for about 20 minutes to dissolve glibenclamide, cool, dilute to the scale with mobile phase, shake, filter, take the filtrate as the test solution, take 2u1 injection of human liquid chromatography with precision, record the chromatogram; Take an appropriate amount of glibenclamide reference, precision weighing, adding an appropriate amount of methanol to dissolve, and quantitatively diluted with mobile phase to prepare a solution containing 50 WW per 1 ml, and determined by the same method. According to the external standard method to calculate the peak area, that is.

category

hypoglycemic drugs.

storage

sealed storage.

Last Update：2024-01-02 23:10:35

1,1-dimethylbiguanide hydrochloride - Standard

Authoritative Data Verified Data

This product is 1, 1-dimethylbiguanide hydrochloride. Calculated as dry product, containing C4H11N5.HC1 shall not be less than 98.5%.

Last Update：2024-01-02 23:10:35

1,1-dimethylbiguanide hydrochloride - Trait

Authoritative Data Verified Data

This product is white crystal or crystalline powder; Odorless.
This product is soluble in water, soluble in methanol, slightly soluble in ethanol, insoluble in chloroform or ether.

melting point

The melting point of this product (General 0612) is 220~225°C.

absorption coefficient

take this product, precision weighing, add water to dissolve and quantitatively dilute to make a solution containing about 5ug per lml, according to UV-visible spectrophotometry (General 0401), the absorbance was measured at a wavelength of 233mn, and the absorption coefficient was 778 to 818.

Last Update：2022-01-01 14:19:46

1,1-dimethylbiguanide hydrochloride - Introduction

This product can reduce fasting and postprandial hyperglycemia in patients with type 2 diabetes, and glycosylated hemoglobin HbAlc can be reduced by 1% ~ 2%. The mechanism of lowering blood sugar of this product may be: ①Increase the sensitivity of surrounding tissues to insulin and increase insulin-mediated glucose utilization; ②Increase the utilization of glucose by non-insulin-dependent tissues, such as brain, blood cells, renal medulla, intestine, skin, etc.; ③Inhibit the effect of liver glycogen, reduce glycogen output; ④ Inhibit glucose uptake by intestinal wall cells; ⑤ Inhibit cholesterol biosynthesis and storage, and reduce blood triglyceride and total cholesterol levels. Different from insulin, this product has no effect on promoting fat synthesis, no obvious hypoglycemic effect on normal people, and generally does not cause hypoglycemia when applied alone to type 2 diabetes. Liquid storage configuration

Last Update：2022-10-16 17:12:07

1,1-dimethylbiguanide hydrochloride - Differential diagnosis

Authoritative Data Verified Data

take about 10 mg of this product, Add 10ml of water to dissolve, add 10% sodium nitroprusside solution-potassium ferricyanide test solution-10% sodium hydroxide solution (equal volume mixing, placed for 20 minutes) 10ml, the solution was red for 3 minutes.
The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 631).
This product is chloride identification reaction (General 0301).

Last Update：2022-01-01 14:19:47

1,1-dimethylbiguanide hydrochloride - Exam

Authoritative Data Verified Data

Related substances

take this product, precision weighing, adding mobile phase to dissolve and quantitatively dilute to make a solution containing about 5mg per lml as a test solution; Take 1ml for precision measurement, in a 200ml measuring flask, dilute to the scale with the mobile phase, shake well, as a control solution; Another dicyandiamide reference substance, precision weighing, dissolving with water and quantitatively diluting to make about 0 in 1ml. An appropriate amount of 1 mg solution was quantitatively diluted with the mobile phase to prepare a solution containing about 1ml per 1ml as a reference solution. According to the high performance liquid chromatography (General 0512) test, the sulfonic acid group cation exchange bonded silica gel is used as the filler, and the 1.7% ammonium dihydrogen phosphate solution (adjusted to pH 3.0 with phosphoric acid) is used as the mobile phase, the detection wavelength was 218nm. Take metformin hydrochloride and melamine, add water to dissolve and dilute to make 0.25mg of metformin hydrochloride and melamine per 1 ml. lmg solution, take lml, dilute to 50ml with mobile phase, shake, take 10u1 injection liquid chromatograph, record chromatogram, the resolution of metformin peak and melamine peak should be greater than 10.0. l0ul of the test solution, the control solution and the reference solution were respectively injected into the liquid chromatograph, and the chromatogram was recorded to 2 times of the retention time of the metformin peak. If there is a peak in the chromatogram of the test solution that is consistent with the retention time of the dicyandiamide peak in the chromatogram of the reference solution, the peak area shall be calculated according to the external standard method and shall not exceed 0.02%, the Peak area of other individual impurities shall not be greater than 0.2 times (0.1%) of the main peak area of the control solution, and the sum of the peak areas of other impurities shall not be greater than the main peak area of the control solution (0.5%).

loss on drying

take this product, dry to constant weight at 105°C, weight loss shall not exceed 0.5% (General rule 0831).

ignition residue

not more than 0.1% (General rule 0841).

Heavy metals

This product l.Og, inspection according to law (General Principles 0821 The first law), containing heavy metals shall not exceed 20 parts per million.

Last Update：2022-01-01 14:19:47

1,1-dimethylbiguanide hydrochloride - Content determination

Authoritative Data Verified Data

take this product about 60mg, precision weighing, add anhydrous formic acid 4ml to dissolve, add acetic anhydride 50ml, fully mixed, according to the potential titration method (General 0701), with perchloric acid titration solution (0.1 mol/L) titration, and the results of the titration were corrected with a blank test. Each 1 ml of perchloric acid titration solution (0.1 mol/L) corresponds to 8.282mg of C4H11N5. Hc1.

Last Update：2022-01-01 14:19:48

1,1-dimethylbiguanide hydrochloride - Category

Authoritative Data Verified Data

hypoglycemic drugs.

Last Update：2022-01-01 14:19:48

1,1-dimethylbiguanide hydrochloride - Storage

Authoritative Data Verified Data

sealed storage.

Last Update：2022-01-01 14:19:48

1,1-dimethylbiguanide hydrochloride - Metformin Hydrochloride And Glibenclamide Tablets(Ⅰ) (II)

Authoritative Data Verified Data

This product contains metformin hydrochloride (C4H11N s • HC1) should be 95.0% ~ 105.0% of label amount; Containing glibenclamide (C23H28C1N305S) should be 90.0% ~ 110.0% of label amount.

trait

This product is white to off-white or film-coated, white or off-white after removal of the coating.

identification

take an appropriate amount of fine powder of this product (about 50mg equivalent to metformin hydrochloride), add 10ml of water, shake to dissolve dimethyl hydrochloride double Fox, filter, add 10% sodium nitroprusside ferricyanide solution-potassium ferricyanide test solution-10% sodium hydroxide solution (mixed in equal volume, placed for 20 minutes) l0ml, and the solution is red within 3 minutes.
the sample solution for the content determination of metformin hydrochloride was measured by ultraviolet-visible spectrophotometry (General 0401), and the maximum absorption was found at a wavelength of 233nm.
in the chromatogram recorded under the content determination of glibenclamide, the retention time of the main Bee of the test solution should be consistent with the retention time of the main peak of the control solution.
The filtrate under identification (1) shall show the reaction of chloride identification (1) (General 0301).

examination

Related substances take 30 tablets of this product, remove the coating, grind it finely, weigh an appropriate amount (about 50mg equivalent to metformin hydrochloride), put it in a 100ml measuring flask, and add an appropriate amount of mobile phase, ultrasonic about 5 minutes to dissolve metformin hydrochloride, cool, dilute to scale with mobile phase, shake, filter, and take the filtrate as the test solution, dissolved and quantitatively diluted with mobile phase to make about 0.1 mg of the solution, as dicyandiamide control solution; Another appropriate amount of melamine, dissolved and diluted with mobile phase to make a solution containing about 0.2mg per 1ml, as melamine solution d, 1ml of each of the above three Solutions was accurately measured, placed in the same 200ml measuring flask, diluted to the scale with mobile phase, and shaken, as a control solution. According to the high performance liquid chromatography (General rule 0512) test, using sulfonic acid group cation exchange bonded silica gel as filler, with ammonium dihydrogen phosphate solution (take ammonium dihydrogen phosphate 17g, add water to dissolve 3.0, adjust the pH value to with phosphoric acid) as the mobile phase, the detection wavelength is 218nm, the number of theoretical plate according to the dicyandiamide peak is not less than 5000, the separation degree of metformin peak and melamine peak should be greater than 10.0. Take 10ul of the test solution and the control solution respectively, inject the human liquid chromatograph, record the chromatogram to 2 times of the chromatographic peak retention time of metformin. If there is a dicyandiamide peak in the chromatogram of the test solution, the peak area shall be calculated according to the external standard method, and 0.04% of the labeled amount of metformin hydrochloride shall not be passed. If there are other impurity peaks, the Peak area of a single impurity peak (retention time after dicyandiamide peak) shall not be greater than 0.4 times (0.2%) of the peak area of metformin in the control solution, and other impurity peaks (retention time after dicyandiamide peak) the sum of the peak areas should not be greater than 2 times (1.0%) The Peak area of metformin in the control solution.
impurity I and impurity II: Weigh an appropriate amount of fine powder under the items of related substances (about 12.5mg of Glibenclamide), put it in a 25ml measuring flask, and add 16ml of methanol, sonicate for about 20 minutes and shake to dissolve glibenclamide, let it cool, dilute to scale with ammonium dihydrogen phosphate solution (take ammonium dihydrogen phosphate 1.725g, add water 300ml to dissolve, adjust pH to 3.5±0.05 with phosphoric acid), shake well, after centrifugation, the supernatant was filtered, and the filtrate was continued as the test solution. 4-[2-(5-chloro-2-methoxybenzamide)-ethyl]-benzenesulfonamide (impurity I) 4-[2-(5-chloro-2-methoxybenzamide)-ethyl]-benzenesulfonylamino-ethyl formate (impurity II), dissolve and quantitatively dilute with methanol to make a solution containing about 0.3mg of each of impurity I and impurity II in each lm l. Take 1ml for precise measurement, put it in a 100ml measuring flask, and dilute to the mark with mobile phase, shake well as a control solution. According to the chromatographic conditions under the content determination of glibenclamide, take the sample solution and the reference solution of 204, respectively, injection of human liquid chromatography, the chromatogram was recorded to 2 times the retention time of the glitazone peak. If there are chromatographic peaks corresponding to impurity I and impurity II in the reference solution in the chromatogram of the test solution, the peak area shall be calculated according to the external standard method, and shall not exceed 0.6%.
Content uniformity glibenclamide take 1 tablet of this product, put it in 50ml measuring flask (glibenclamide 2.5mg specification) or 100ml measuring flask (glibenclamide 5mg specification), add appropriate amount of mobile phase, glibenclamide was dissolved by ultrasound for about 20 minutes, allowed to cool, diluted to the scale with mobile phase, shaken, filtered, and the filtrate was taken as the test solution. According to the content determination of glibenclamide under the method of determination of glibenclamide content, should comply with the provisions (General 0941).
dissolution: according to the method for determination of dissolution and release (General rule 0931, Method 3), 0.02% Tris solution 250tnl was used as the dissolution medium, and the rotation speed was 75 rpm, after 45 minutes, 10ml of the solution was taken, filtered, and the filtrate was prepared.
metformin hydrochloride the appropriate amount of the above filtrate is accurately measured and diluted with dissolution medium to prepare a solution containing 5ug of metformin hydrochloride (calculated according to the labeled amount) per 1 ml as a test solution, measure absorbance at 233nm wavelength according to UV-Vis spectrophotometry (General rule 0401); Take appropriate amount of metformin hydrochloride reference substance accurately, the dissolution medium was added and dissolved and quantitatively diluted to prepare a solution containing about 1 ml per 1 ml, which was used as a reference solution and was measured by the same method. The amount of metformin hydrochloride dissolved in each tablet was calculated. The limit is 80% of the labeled amount and shall be in accordance with the provisions.
glibenclamide the above filtrate was taken as a test solution. Weigh about 12.5mg of glibenclamide reference substance accurately, put it in a 25ml measuring flask, add an appropriate amount of methanol, sonicate for about 20 minutes to dissolve glibenclamide, let it cool, dilute it to scale with methanol, shake it well, take 1ml accurately, put 50ml measuring flask (glyburide 2.5mg specification) or 25ml measuring flask (glyburide 5mg specification), dilute to the scale with dissolution medium, shake, as a reference solution. According to the chromatographic conditions under the content determination of glibenclamide, the detection wavelength is changed to 225mn, and 20m of the test solution and the reference solution are accurately measured. Human liquid chromatograph is injected respectively, and the chromatogram is recorded. The dissolution amount of glibenclamide in each tablet was calculated by peak area according to external standard method. The limit is 75% of the labeled amount and shall be in accordance with the provisions.
others shall be in accordance with the relevant provisions under the item of tablets (General rule 0101).

Content determination

metformin hydrochloride 20 tablets, precision weighing, fine grinding, precision weighing an appropriate amount (equivalent to metformin hydrochloride 50mg), put in a 100ml measuring flask, add an appropriate amount of water, ultrasonic for about 5 minutes to dissolve metformin hydrochloride, let it cool, dilute to scale with water, shake well, filter, take 1ml of filtrate accurately, put it in a 100ml measuring flask, dilute to scale with water, shake well, measure absorbance at 233nm wavelength according to UV-Vis spectrophotometry (General rule 0401); Take appropriate amount of metformin hydrochloride reference substance accurately, water was added to dissolve and quantitatively diluted to prepare a solution containing about 5 nerves per 1ml. As a reference solution, the solution was measured and calculated by the same method.
glibenclamide was measured by high performance liquid chromatography (General 0512).
chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica gel as filler; Methanol-ammonium dihydrogen phosphate solution (take ammonium dihydrogen phosphate 1.725g, add water 300ml to dissolve, adjust pH value to 3.5±0.05 with phosphoric acid)(50: 30) as mobile phase; The detection wavelength was 300nm. The reference solution 20pl under impurity I and impurity II inspection items is injected into human liquid chromatograph, and the chromatogram is recorded. The separation degree of impurity I peak and impurity II peak shall meet the requirements.
accurate weighing the appropriate amount of fine powder (about 5mg of Glibenclamide) under the content determination item of metformin hydrochloride, placing it in a 100ml measuring flask, adding the appropriate amount of mobile phase, sonicating for about 20 minutes to dissolve glibenclamide, cool, dilute to the scale with mobile phase, shake, filter, take the filtrate as the test solution, take 20ul injection into the human liquid chromatograph, record the chromatogram; Take an appropriate amount of glibenclamide reference, precision weighing, and mobile phase dissolution and quantitative dilution of solution containing 50 in each lml, the same method. According to the external standard method to calculate the peak area, that is.

category

hypoglycemic drugs.

storage

sealed storage.

Last Update：2022-01-01 11:29:36

1,1-dimethylbiguanide hydrochloride - Metformin and glibenclamide capsules (I)

Authoritative Data Verified Data

This product contains metformin hydrochloride (C4H11N5 • HC1) should be 95.0% ~ 105.0% of label amount; Containing glibenclamide (C23H28C1N305S) should be 90.0% ~ 110.0% of label amount.

trait

The contents of this product are white to off-white particles or powder.

identification

take an appropriate amount of the content of this product (about 50mg of metformin hydrochloride), add 10ml of water, shake to dissolve metformin hydrochloride, filter, and take 2ml of continued filtrate, 10ml of 10% sodium nitrosoferricyanide solution-potassium ferricyanide test solution-10% sodium hydroxide solution (mixed in equal volume, used after being left for 20 minutes) was added, and the solution was red within 3 minutes.
the sample solution for the content determination of metformin hydrochloride was measured by ultraviolet-visible spectrophotometry (General 0401), and the maximum absorption was found at a wavelength of 233nm.
in the chromatogram recorded under the content determination of glibenclamide, the retention time of the main peak of the test solution should be consistent with the retention time of the main peak of the control solution.
The filtrate under identification (1) was taken to show chloride to identify the reaction of (1) (General 0301).

examination

Related substances take the contents of 30 capsules of this product, grind them finely, weigh an appropriate amount (about 50mg equivalent to metformin hydrochloride), put them in a 100ml measuring flask, and add an appropriate amount of mobile phase, ultrasonic about 5 minutes to dissolve metformin hydrochloride, cool, dilute to scale with mobile phase, shake, filter, and take the filtrate as the test solution, dissolved and quantitatively diluted with mobile phase to make about 0.1 mg of the solution was used as the dicyandiamide reference solution; An appropriate amount of melamine was additionally taken, and the mobile phase was added to dissolve and diluted to prepare a solution containing about 0.2mg per 1ml as the melamine solution. 1ml of each of the above three kinds of solution was accurately measured and placed in the same 200ml measuring flask, diluted to the scale with mobile phase, and shaken as a control solution. According to the high performance liquid chromatography (General rule 0512) test, using the cellulose-based cation exchange bonded silica gel as the filler, the ammonium dihydrogen phosphate solution (17g of ammonium dihydrogen phosphate, and of water were added to dissolve, using phosphoric acid to adjust the pH value to 3.0) as mobile phase, the detection wavelength is 218nm, the theoretical plate number is not lower by 5000 according to the dicyandiamide peak, and the resolution of metformin peak and melamine peak should be greater than 10.0. Take 100 of each of the control solution and the test solution, respectively inject human liquid phase spectrometer, record the chromatogram to 2 times the retention time of metformin peak. If there is a dicyandiamide peak in the chromatogram of the test station solution, 0.04% of the labeled amount of metformin hydrochloride shall not be calculated by the peak area according to the external standard method. If there are other impurity peaks, the Peak area of single impurity peak (retention time after dicyandiamide peak) shall not be greater than 0.4 times (0.2%) of the peak area of metformin in control W solution, and other impurity peaks (retention time after dicyandiamide peak) the sum of the peak areas should not be greater than 2 times (1.0%) The Peak area of metformin in the control solution.
impurity I and impurity II: Weigh an appropriate amount of fine powder under the items of related substances (about 12.5mg of Glibenclamide), put it in a 25ml measuring flask, and add 16ml of methanol, sonicate for about 20 minutes and shake to dissolve glibenclamide, let it cool, dilute to the scale with ammonium dihydrogen phosphate W solution (take ammonium dihydrogen phosphate 1.725g, add water 300ml to dissolve, adjust pH to 3.5±0.05 with phosphoric acid), shake well, centrifuge, take the supernatant to filter, filtrate as test solution; Take 4-[2-(5-chloro-2-methoxybenzamide)-Ethyl]-benzenesulfonamide (impurity I) pair with 4-[2-(5-chloro-2-methoxybenzylamine)-Ethyl]-benzenesulfonylamino-ethyl formate (impurity II) standard, precision weighing, add methanol to dissolve and dilute quantitatively to make a solution containing 0.3mg of each of impurity I and impurity II in 1ml. Take 1ml of the solution in a 100ml measuring flask, dilute to the mark with mobile phase, and shake well, as a control solution. According to the chromatographic conditions under the content determination of glibenclamide, 20ul of each of the reference solution and the test solution were injected into the liquid chromatograph respectively, and the chromatogram was recorded to 2 times of the peak retention time of glibenclamide. If there are chromatographic peaks corresponding to impurity I and impurity II in the reference solution in the chromatogram of the test solution, the peak area shall be calculated according to the external standard method, and shall not exceed 0.6%.
Content uniformity glibenclamide take 1 capsule of this product, put it in a 25ml measuring flask, add an appropriate amount of methanol, sonicate for about 20 minutes to dissolve glibenclamide, let it cool, dilute to scale with mobile phase, shake well, after filtration, the secondary filtrate was taken as a test solution. According to the content determination of glibenclamide under the method of determination of glibenclamide content, should comply with the provisions (General 0941).
dissolution: according to the dissolution and release determination method (General rule 0931 method), 0.02% Tris solution is used as the dissolution medium, and the rotation speed is 7 rpm, after 45 minutes, 10ml of the solution was taken, filtered, and the filtrate was prepared.
metformin hydrochloride the appropriate amount of the above filtrate was quantitatively diluted with dissolution medium to prepare a solution containing 5mg of metformin hydrochloride (calculated according to the labeled amount of metformin hydrochloride) per 1ml as a test solution, according to UV-Vis spectrophotometry (General rule 0401), measure absorbance at 233nm wavelength, and accurately weigh appropriate amount of metformin hydrochloride reference substance, the dissolution medium was added and dissolved and quantitatively diluted to prepare a solution containing about 5ug per 1ml as a reference solution, which was determined by the same method. The amount of metformin hydrochloride dissolved in each capsule was calculated. The limit is 80% of the labeled amount and shall be in accordance with the provisions.
glibenclamide the above filtrate was taken as a test solution. Weigh about 12.5mg of glibenclamide reference substance accurately, put it in a 25ml measuring flask, add an appropriate amount of methanol, sonicate for about 20 minutes to dissolve glibenclamide, let it cool, dilute it to scale with methanol, shake it well, take 1ml of precision, 100ml flask, diluted with dissolution medium to scale, shake, as a reference solution. According to the chromatographic conditions under the content determination of glibenclamide, the detection wavelength is changed to 225nm, and 20 u1 of each of the test solution and the reference solution are accurately measured and injected into the liquid chromatograph respectively, and the chromatograms are recorded. The dissolution amount of glibenclamide in each pellet was calculated by peak area according to external standard method. The limit is 75% of the labeled amount and shall be in accordance with the provisions.
others should comply with the relevant provisions under the capsule (General 0103).

Content determination

metformin hydrochloride take the contents of 20 tablets of this product, precision weighing, fine grinding, precision weighing an appropriate amount (about 50mg equivalent to metformin hydrochloride), put it in a 100ml measuring flask, and add an appropriate amount of water, ultrasonic for about 5 minutes to dissolve metformin hydrochloride, let it cool, dilute to scale with water, shake well, filter, take 1ml of filtrate accurately, put it in a 100ml measuring flask, dilute to scale with water, shake well, according to UV-visible spectrophotometry (General rule 0401), determine absorbance at 233nm wavelength, and accurately weigh appropriate amount of metformin hydrochloride reference substance, water was added to dissolve and quantitatively diluted to prepare a solution containing about 5ug per 1ml, which was determined and calculated by the same method as the reference solution.
glibenclamide was measured by high performance liquid chromatography (General 0512).
chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica gel as filler; Methanol-ammonium dihydrogen phosphate solution (take ammonium dihydrogen phosphate 1.725g, add water 300ml to dissolve, adjust pH value to 3.5±0.05 with phosphoric acid)(50:30) as mobile phase; The detection wavelength was 300nm. The reference solution 20u1 under impurity I and impurity II inspection items is injected into the liquid chromatograph, and the chromatogram is recorded. The separation degree of impurity I peak and impurity II peak shall meet the requirements.
precise weighing the appropriate amount of fine powder (about 5mg equivalent to Glibenclamide) under the content determination item of metformin hydrochloride, placing it in a 100ml measuring flask, adding the appropriate amount of methanol, sonicating for about 20 minutes to dissolve glibenclamide, cool, dilute to the scale with mobile phase, shake well, filter and take the filtrate as the test solution, and inject 200 into the liquid chromatograph to record the chromatogram, precision weighing, adding an appropriate amount of methanol to dissolve, and quantitatively diluted with mobile phase to prepare a solution containing 50ug per 1ml, and determined by the same method. According to the external standard method to calculate the peak area, that is.

category

hypoglycemic drugs.

storage

sealed storage.

Last Update：2022-01-01 11:29:38

1,1-dimethylbiguanide hydrochloride - Metformin and glibenclamide capsules (II)

Authoritative Data Verified Data

This product contains metformin hydrochloride (C4H11N5 • HC1) should be 95.0% ~ 105.0% of label amount; Containing glibenclamide (C23H28C1N305S) should be 90.0% ~ 110.0% of label amount.

trait

The contents of this product are white to off-white particles or powder.

identification

take an appropriate amount of the content of this product (about 50mg of metformin hydrochloride), add 10ml of water, shake to dissolve metformin hydrochloride, filter, and take 2ml of continued filtrate, 10ml of 10% sodium nitrosoferricyanide solution-potassium ferricyanide test solution-10% sodium hydroxide solution (mixed in equal volume, used after being left for 20 minutes) was added, and the solution was red within 3 minutes.
the sample solution for the content determination of metformin hydrochloride was measured by ultraviolet-visible spectrophotometry (General 0401), and the maximum absorption was found at a wavelength of 233mn.
in the chromatogram recorded under the content determination of glibenclamide, the retention time of the main peak of the test solution should be consistent with the retention time of the main peak of the control solution.
The filtrate under the item of identification (1) should show the reaction of the product identification (1) (General 0301).

examination

Related substances take the contents of 30 capsules of this product, grind them finely, weigh an appropriate amount (about 50mg equivalent to metformin hydrochloride), put them in a 100ml measuring flask, and add an appropriate amount of mobile phase, ultrasonic about 5 minutes to dissolve metformin hydrochloride, cool, dilute to scale with mobile phase, shake, filter, and take the filtrate as the test solution, dissolved and quantitatively diluted with mobile phase to make about 0.1 mg of the solution was used as the dicyandiamide reference solution; An appropriate amount of melamine was additionally taken, and the mobile phase was added to dissolve and dilute to prepare a solution containing about 0.2mg per 1 ml as the melamine solution. 1 ml of each of the above three Solutions was accurately measured and placed in the same 200ml measuring flask, diluted to the scale with mobile phase, and shaken to serve as a control solution. According to the high performance liquid chromatography (General rule 0512) test, using sulfonic acid group cation exchange bonded silica gel as filler, with ammonium dihydrogen phosphate solution (take ammonium dihydrogen phosphate 17g, add water 1000ml, dissolve, Using phosphoric acid to adjust the pH value to 3.0) as mobile phase, the detection wavelength is 218nm, the number of theoretical plate is not less than 5000 according to the dicyandiamide peak, and the separation degree of metformin peak and melamine peak should be greater than 10.0. The control solution and the test solution were respectively injected with 10P1, and the chromatogram was recorded to 2 times of the retention time of metformin peak. If there is a dicyandiamide peak in the chromatogram of the test solution, 0.04% of the labeled amount of metformin hydrochloride shall not be calculated by the peak area according to the external standard method. If there are other impurity peaks, the Peak area of a single impurity peak (retention time after dicyandiamide peak) shall not be greater than 0.4 times (0.2%) of the peak area of metformin in the control solution, and other impurity peaks (retention time after dicyandiamide peak) the sum of peak areas shall not be greater than 2 times (1.0%) The Peak area of the dimethyl double Fox in the control solution.
impurity I and impurity II: Weigh an appropriate amount of fine powder under the items of related substances (about 12.5mg of Glibenclamide), put it in a 25ml measuring flask, and add 16ml of methanol, sonicate for about 20 minutes and shake to dissolve glibenclamide, let it cool, dilute to scale with ammonium dihydrogen phosphate solution (take ammonium dihydrogen phosphate 1.725g, add water 300ml to dissolve, adjust pH to 3.5±0.05 with phosphoric acid), shake well, after centrifugation, the supernatant was filtered, and the filtrate was continued as the test solution. 4-[2-(5-chloro-2-methoxybenzamide)-ethyl]-benzenesulfonamide (impurity I) 4-[2-(5-chloro-2-methoxybenzamide)-ethyl]-benzenesulfonylamino-ethyl formate (impurity II), add methanol to dissolve and quantitatively dilute to make a solution containing 0.3mg of each of impurity I and impurity II in 1ml. Take 1ml of the solution in a 100ml measuring flask, dilute to the mark with mobile phase, and shake well, as a control solution. According to the chromatographic conditions under the content determination of glibenclamide, 20 u1 of the reference solution and the test solution were respectively injected into the liquid chromatograph, and the chromatogram was recorded to 2 times of the retention time of the glibenclamide peak. If there are chromatographic peaks corresponding to impurity I and impurity II in the reference solution in the chromatogram of the test solution, the peak area shall be calculated according to the external standard method, and shall not exceed 0.6%.
Content uniformity glibenclamide take 1 capsule of this product, put it in a 50ml measuring flask, add an appropriate amount of methanol, sonicate for about 20 minutes to dissolve glibenclamide, let it cool, dilute to scale with mobile phase, shake well, after filtration, the secondary filtrate was taken as a test solution. According to the content determination of glibenclamide under the method of determination of glibenclamide content, should comply with the provisions (General 0941).
dissolution: according to the dissolution and release determination method (General rule 0931 method), 0.02% Tris solution is used as the dissolution medium, and the rotation speed is 75 rpm, after 45 minutes, 10ml of the solution was taken, filtered, and the filtrate was prepared.
metformin hydrochloride the appropriate amount of the above filtrate was quantitatively diluted with dissolution medium to prepare a solution containing 5ug of metformin hydrochloride (calculated according to the labeled amount of metformin hydrochloride) per 1 ml as a test solution, according to UV-Vis spectrophotometry (General rule 0401), measure absorbance at 233nm wavelength, and accurately weigh appropriate amount of metformin hydrochloride reference substance, the dissolution medium was added and dissolved and quantitatively diluted to prepare a solution containing about 5ug per 1 ml as a reference solution, which was determined by the same method. The amount of metformin hydrochloride dissolved in each capsule was calculated. The limit is 80% of the labeled amount and shall be in accordance with the provisions.
glibenclamide the above filtrate was taken as a test solution. Weigh about 12.5mg of glibenclamide reference substance accurately, put it in a 25ml measuring flask, add an appropriate amount of methanol, sonicate for about 20 minutes to dissolve glibenclamide, let it cool, dilute it to scale with methanol, shake it well, take 1 ml accurately, put it in a 50ml measuring flask, dilute it to the scale with dissolution medium, and shake it well to serve as a reference solution. According to the chromatographic conditions under the content determination of glibenclamide, the detection wavelength is changed to 225nm, and 20 u1 of the test solution and the reference solution are accurately measured. Human liquid chromatograph is injected respectively, and the chromatogram is recorded. The dissolution amount of glibenclamide in each pellet was calculated by peak area according to external standard method. The limit is 75% of the labeled amount and shall be in accordance with the provisions.
others should comply with the relevant provisions under the capsule (General 0103).

Content determination

metformin hydrochloride take the contents of 20 tablets of this product, precision weighing, fine grinding, precision weighing an appropriate amount (about 50mg equivalent to metformin hydrochloride), put it in a 100ml measuring flask, and add an appropriate amount of water, ultrasonic for about 5 minutes to dissolve metformin hydrochloride, let it cool, dilute to scale with water, shake well, filter, take 1ml of filtrate accurately, put it in a 100ml measuring flask, dilute to scale with water, shake well, according to UV-Vis spectrophotometry (General rule 0401), measure absorbance at 233nm wavelength, and accurately weigh appropriate amount of metformin hydrochloride reference substance, water was added to dissolve and quantitatively diluted to prepare a solution containing about 5ug per 1ml, which was determined and calculated by the same method as the reference solution.
glibenclamide was measured by high performance liquid chromatography (General 0512).
chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica gel as filler; Methanol-ammonium dihydrogen phosphate solution (take ammonium dihydrogen phosphate 1.725g, add water 300ml to dissolve, adjust pH value to 3.5±0.05 with phosphoric acid)(50:30) as mobile phase; The detection wavelength was 300nm. 200 of the reference solution under impurity I and impurity II inspection items is injected into the liquid chromatograph, and the chromatogram is recorded. The separation degree of impurity I and impurity II peaks shall meet the requirements.
precise weighing method to determine the amount of fine powder under the item of metformin hydrochloride (about 5mg equivalent to Glibenclamide), placing it in a 100ml measuring flask, adding the appropriate amount of methanol, sonicating for about 20 minutes to dissolve glibenclamide, cool, dilute to the scale with mobile phase, shake, filter, take the filtrate as the test solution, inject 20ul into the liquid chromatograph with precision, record the chromatogram; Take the appropriate amount of glibenclamide reference, precision weighing, adding an appropriate amount of methanol to dissolve, and quantitatively diluted with mobile phase to prepare a solution containing 50ug per 1ml, and determined by the same method. According to the external standard method to calculate the peak area, that is.

category

hypoglycemic drugs.

storage

sealed storage.

Last Update：2022-01-01 11:29:39

1,1-dimethylbiguanide hydrochloride - Metformin Hydrochloride Tablets

Authoritative Data Verified Data

This product contains metformin hydrochloride (C4H11N5 • HCI) should be 95.0% ~ 105.0% of label amount.

trait

This product is sugar-coated or film-coated tablet, White after removing the coating.

identification

take an appropriate amount of the fine powder of this product (about 50mg of metformin hydrochloride), add 10ml of water to dissolve metformin hydrochloride, filter, and test (1) and (3) under the item of metformin hydrochloride, the same reaction was shown.
the sample solution under the content measurement item was taken and measured by ultraviolet-visible spectrophotometry (General rule 0401), and there was a maximum absorption at a wavelength of 233nm.

examination

the dissolution of this product, according to the dissolution and release determination method (General rule 0931 method), with water 1000ml as the dissolution medium, the speed is 100 rpm, according to the law, after 45 minutes, take the appropriate amount of the solution, filter, discard the initial filtrate 10ml, accurately take the appropriate amount of filtrate, and quantitatively dilute with water to make a solution containing about 5ug per lml, the dissolution amount of each tablet was calculated as measured by the method under the content measurement item. The limit is 70% of the labeled amount and shall be in accordance with the provisions.
relevant substances: take an appropriate amount of the fine powder of this product (about 500mg of metformin hydrochloride), weigh it accurately, place it in a 100ml measuring flask, add an appropriate amount of mobile phase, and sonicate for 15 minutes to dissolve metformin hydrochloride, dilute to the scale with mobile phase, shake, and take the continued filtrate as the test solution; Determine the related substances of metformin hydrochloride according to the method under the item. If there is a peak in the chromatogram of the test solution that is consistent with the retention time of the dicyandiamide peak in the chromatogram of the reference solution, the peak area shall be calculated according to the external standard method, and the peak area shall not exceed 0.02% of the labeled amount of metformin hydrochloride, the Peak area of other individual impurities shall not be greater than 0.2 times (0.1%) of the main peak area of the control solution, and the sum of the peak areas of other impurities shall not be greater than 1.2 times (0.6%) of the main peak area of the control solution.
others shall be in accordance with the relevant provisions under the item of tablets (General rule 0101).

Content determination

Take 20 tablets of this product, precision weighing, fine grinding, precision weighing appropriate amount (about equivalent to hydrochloric acid two biguanide lOOmg), put 100ml flask, add appropriate amount of water, ultrasonic for 15 minutes to dissolve metformin hydrochloride, dilute to the scale with water, shake well, filter, discard the initial filtrate 20ml, and take the appropriate amount of filtrate, A solution containing about 5 carbs of metformin hydrochloride in 1 ml was prepared by quantitative dilution with water, and used as a test solution. The absorbance was measured at the wavelength of 233nm by ultraviolet-visible spectrophotometry (General rule 0401); another reference substance of metformin hydrochloride was carefully weighed, dissolved with water and quantitatively diluted to make a solution containing about 5ug per 1 ml, which was determined by the same method. It is obtained by calculation.

category

Same as metformin hydrochloride.

specification

0.25g

storage

sealed storage.

Last Update：2022-01-01 14:19:49

1,1-dimethylbiguanide hydrochloride - Metformin hydrochloride enteric-coated tablets

Authoritative Data Verified Data

This product contains metformin hydrochloride (C4H11N5 • HC1) should be 95.0% ~ 105.0% of the label amount.

trait

This product is an enteric-coated tablet, White after removing the coating.

identification

take an appropriate amount of the fine powder of this product (about 50mg of metformin hydrochloride), add 10ml of water to dissolve metformin hydrochloride, filter, and test (1) and (3) under the item of metformin hydrochloride, the same reaction was shown.
the sample solution under the content measurement item was taken and measured by ultraviolet-visible spectrophotometry (General rule 0401), and there was a maximum absorption at a wavelength of 233mn.

examination

relevant substances: take an appropriate amount of the fine powder of this product (about 500mg of metformin hydrochloride), weigh it accurately, place it in a 100ml measuring flask, add an appropriate amount of mobile phase, and sonicate for 15 minutes to dissolve metformin hydrochloride, dilute to the scale with mobile phase, shake, filter, take the continued filtrate as a test solution; According to the method for the determination of related substances under the item of dimethyl hydrochloride double Fox, the chromatogram was recorded to 4 times the peak retention time of metformin hydrochloride. If there is a peak in the chromatogram of the test solution that is consistent with the retention time of the dicyandiamide peak in the chromatogram of the reference solution, the peak area shall be calculated according to the external standard method, and the peak area shall not exceed 0.02% of the labeled amount of metformin hydrochloride, the Peak area of other individual impurities shall not be greater than 0.2 times (0.1%) of the main peak area of the control solution, and the sum of the peak areas of other impurities shall not be greater than 1.2 times (0.6%) of the main peak area of the control solution.
dissolution of this product, according to the dissolution and release determination method (General rule 0931 first method 2 ) , with 0.100 ml of 1 mol/L hydrochloric acid solution was used as dissolution medium, rotating at RPM, operated according to law. After 1 hour, 20ml of the solution was filtered, and 10ml of the initial filtrate was discarded, take the filtrate as the test solution (1); Immediately raise the basket out of the liquid surface, and then soak the basket in human phosphate buffer (pH 6.8 )(take 0.1 mol/L hydrochloric acid solution and 0.2mol/L sodium phosphate solution, mix evenly according to 3:1, adjust the pH value to 6.8±0.05 with 2mol/L hydrochloric acid solution or 2mol/L sodium hydroxide solution if necessary) in the dissolution medium of 900ml, the rotational speed is unchanged, and the operation is continued according to law. After 45 minutes, 20ml of the solution is filtered, and 10ml of the initial filtrate is discarded, A solution containing about 5ug of metformin hydrochloride in 1 ml is prepared by quantitative dilution with water as the test solution (2 ); Another metformin hydrochloride reference substance is taken and precision weighed, and 0.1 mol/L hydrochloric acid solution was dissolved and quantitatively diluted to prepare a solution containing about 28ug per 1 ml as a reference solution (1); The control solution under the content measurement was taken as the control solution (2). Take the test solution (1), (2) and the reference solution (1), (2 ) , UV-visible spectrophotometry (General 0401), the absorbance was measured at a wavelength of 233nm, and the elution amount of each tablet was calculated. The limit of dissolution in acid is 5% of the labeled amount, and the limit of dissolution in buffer is 85% of the labeled amount.
others shall be in accordance with the relevant provisions under the item of tablets (General rule 0101).

Content determination

Take 20 tablets of this product, precise weighing, fine grinding, precise weighing appropriate amount (about equivalent to 100mg of metformin hydrochloride), put it in a 100ml measuring flask, add 75ml of water, fully shake for 15 minutes, dissolve metformin hydrochloride, dilute to the scale with water, shake well, filter, discard the initial filtrate 20ml, take the appropriate amount of filtrate accurately and dilute quantitatively with water to make a solution containing about 5 beer of metformin hydrochloride per 1 ml, as a test solution, according to UV-visible spectrophotometry (General rule 0401), the absorbance was measured at the wavelength of 233nm; Another metformin hydrochloride reference substance, precision weighing, water is added to dissolve and quantitatively dilute to make a solution containing about 5ug per lml, which is determined and calculated by the same method.

category

Same as metformin hydrochloride.

specification

(1)0.25g (2)0.5g (3)0.85g

storage

sealed storage.

Last Update：2022-01-01 14:19:50

1,1-dimethylbiguanide hydrochloride - Metformin Hydrochloride Enteric-coated Capsules

Authoritative Data Verified Data

This product contains metformin hydrochloride (C4H11N5 • HCl) should be 95.0% to 105.0% of the label.

trait

The contents of this product are white crystalline powder or white to off-white enteric-coated pellets.

identification

take the contents of this product, grind, take an appropriate amount of fine powder (about 50mg of metformin hydrochloride), add 10ml of water to dissolve metformin hydrochloride, filter, and identify (1) and (3) According to metformin hydrochloride one trial showed the same response.
in the chromatogram recorded under the content determination item, the retention time of the main peak of the test solution should be consistent with the retention time of the main peak of the reference solution.

examination

the contents under the check item for the difference in loading of related substances should be weighed finely, and an appropriate amount (equivalent to 0.05% mg of metformin hydrochloride) should be weighed accurately, placed in a 50ml measuring flask, and the appropriate amount of phosphoric acid solution should be added, ultrasonic for 5 minutes to dissolve metformin hydrochloride, dilute to the scale with 0.05% phosphoric acid solution, shake well, filter, accurately take 1ml of continued filtrate, put it in a 25ml measuring flask, dilute to the scale with mobile phase, shake well, as a test solution; Take 1ml of precision measurement, put it in a 200ml measuring flask, dilute it to the scale with mobile phase, shake it well, and use it as a control solution; Take another reference substance of dicyandiamide, weigh it with precision, the mobile phase was added to dissolve and diluted to prepare a solution containing 0.08ug per 1ml as a control solution. Except that the detection wavelength is changed to 218mn, the test shall be carried out according to the chromatographic conditions under the item of content determination, and the number of theoretical plates shall not be less than 2000 based on the dicyandiamide peak. The sample solution, the control solution and the reference solution were respectively injected with 20 u1 for human liquid chromatograph, record the chromatogram to 3 times the retention time of the metformin peak (1) if there are peaks in the chromatogram of the test solution that are consistent with the retention time of the dicyandiamide peak in the chromatogram of the reference solution, the peak area shall be calculated according to the external standard method, 0.02% of the labeled amount of metformin hydrochloride shall not be passed, and the peak area of other individual impurities shall not be greater than 0.2 times (0.1%) of the main peak area of the control solution, the sum of the peak areas of other impurities shall not be greater than 1.2 times (0.6%) of the main peak area of the control solution.
dissolution of this product, according to the dissolution and release determination method (General rule 0931 first method 1), with hydrochloric acid solution (9-1000) as the dissolution medium, after 2 hours, take 20ml of the solution for filtration and discard 10ml of the initial filtrate. Take 2ml of the initial filtrate and put it in a 10ml measuring flask, and dilute it to the scale with mobile phase, shake well as test solution (1 ); Then add 0.2molL sodium phosphate solution preheated to 37°C to each dissolution Cup and mix well, adjust the pH value to 6.8 with 2mol/L hydrochloric acid solution or 2mol/L sodium hydroxide solution, and continue the dissolution for 30 minutes (if the content is white crystalline powder) or 45 minutes (the content is white to the white enteric-coated pellets are applicable), take the solution 20ml filtration, discard the initial filtrate 10ml, take the appropriate amount of filtrate, A solution containing about 20ug of metformin hydrochloride per 1 ml was prepared by quantitative dilution with the mobile phase as a test solution (2). 20 u1 of each of the test solution (1) and (2) are accurately measured according to the method under the content measurement item, and the dissolution amount of each particle is calculated by the peak area according to the external standard method. The amount of dissolution in acid shall not be more than 10% of the labeled amount, and the amount of dissolution in buffer shall not be less than 80% of the labeled amount.
others should comply with the relevant provisions under the capsule (General 0103).

Content determination

measured by high performance liquid chromatography (General 0512).
chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica gel as filler; 0.05% sodium heptane sulfonate solution (adjusted to pH 10% with 4.0 phosphoric acid solution)-acetonitrile (84:16) the detection wavelength was 233nm. The number of theoretical plates shall not be less than 2000 based on the metformin peak.
the content under the item of loading amount difference was measured, and the content was finely divided, and an appropriate amount (about 50mg equivalent to metformin hydrochloride) was accurately weighed, placed in a 200ml measuring flask, and buffer solution (0.0.2 mol/L hydrochloric acid solution, add 6.8 moI/L sodium phosphate solution, mix well, if necessary, adjust the pH value to with 2mol/L hydrochloric acid solution or 2mol/L sodium hydroxide solution, shake for 10 minutes to dissolve metformin hydrochloride, dilute to the scale with the above buffer, shake, filter, discard the initial filtrate 20ml, and take the continuous filtrate, A solution containing about 20ug of metformin hydrochloride in every lml was prepared by quantitative dilution with mobile phase, which was used as a test solution, and 20 u1 was taken from precision children and injected into human liquid chromatograph to record the chromatogram; another precision weighing metformin hydrochloride reference, and mobile phase dissolved and quantitatively diluted into each 1 ml containing about 20ug of the solution, with the same method of determination ^ According to the external standard method with peak product calculation, that is obtained.

category

Same as metformin hydrochloride.

specification

(1)0.25g (2) 0.5g

storage

light shielding, sealed storage.

Last Update：2022-01-01 14:19:51

1,1-dimethylbiguanide hydrochloride - Metformin hydrochloride capsules

Authoritative Data Verified Data

This product contains metformin hydrochloride (C4H11N5 • HC1) should be the standard not to withdraw 95.0% ~ 105.0%.

trait

The content of this product is white particles or powder.

identification

take an appropriate amount of the content of this product (about 10mg of metformin hydrochloride), add 10ml of water to dissolve metformin hydrochloride, filter, and test (1) and (3) under the item of metformin hydrochloride, (B) the same reaction.
the sample solution under the content measurement item was taken and measured by ultraviolet-visible spectrophotometry (General rule 0401), and there was a maximum absorption at a wavelength of Nm.

examination

Related substances take the contents of this product (about 500mg equivalent to metformin hydrochloride), accurately weigh it, put it in a 100ml measuring flask, add the mobile compatible child, sonicate for 15 minutes to dissolve metformin hydrochloride and dilute it to the scale with the mobile phase, shake well, filter, take the continued filtrate as a test solution, according to the method under the item of metformin hydrochloride related substances. If there is a peak in the chromatogram of the test solution that is consistent with the retention time of the dicyandiamide peak in the chromatogram of the reference solution, the peak area shall be calculated according to the external standard method, and the peak area shall not exceed 0.02% of the labeled amount of metformin hydrochloride, the Peak area of other individual impurities shall not be greater than 0.2 times (0.1%) of the main peak area of the control solution, and the sum of the peak areas of the impurity shall not be greater than 1.2 times (0.6%) of the main peak area of the control solution.
the dissolution of this product, according to the dissolution and release determination method (General rule 0931 method), with water 1000ml as the dissolution medium, the speed is 100 rpm, according to the law, after 30 minutes, take the appropriate amount of the solution, filter, discard 10ml of the initial filtrate, take the exact amount of the filtrate, dilute it with water, and make a solution containing about 5ug per 1 ml, as the test solution, the dissolution amount of each pellet was calculated according to the measurement method under the content measurement item. The limit is 75% of the labeled amount and shall be in accordance with the provisions.
others should comply with the relevant provisions under the capsule (General 0103).

Content determination

take the contents under the difference of loading amount, mix evenly, weigh an appropriate amount (about equivalent to metformin hydrochloride lOOmg) precisely, put it in a 100ml measuring flask, add an appropriate amount of water, and shake to dissolve metformin hydrochloride, dilute to the scale with water, shake, filter, discard the initial filtrate 20ml, take the appropriate amount of filtrate accurately, and dilute quantitatively with water to make a solution containing about 5pg of metformin hydrochloride per 1 ml, as a test solution, according to UV-visible spectrophotometry (General rule 0401), the absorbance was measured at the wavelength of 233nm; Another metformin hydrochloride reference substance, precision weighing, water is added to dissolve and quantitatively dilute to make a solution containing about 5ug per lml, which is determined and calculated by the same method.

category

Same as metformin hydrochloride.

specification

0.25g

storage

sealed storage.

Last Update：2022-01-01 14:19:52

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Hubei YoungXin Pharmaceutical Tech Co.,Ltd.

Spot supply

Product Name: Metformin Visit Supplier Webpage Request for quotation
CAS: 1115-70-4
Tel: 0714-3999186
Email: 2853786052@qq.com
Mobile: 86+15671228036
QQ: 2853786052

Wechat: 15671228036

Hefei TNJ Chemical Industry Co.,Ltd.

Product Name: Metformin HCL Request for quotation
CAS: 1115-70-4
Tel: 0086-551-65418684
Email: sales@tnjchem.com
　　　　 info@tnjchem.com
Mobile: 0086 189 4982 3763
QQ: 2881500840

Wechat: 0086 189 4982 3763
WhatsApp: 0086 189 4982 3763
Product List: View Catalog

Shanghai Yuanye Bio-Technology Co., Ltd.

Multiple SpecificationsSpot supply

Product Name: 1,1-Dimethylbiguanide hydrochloride Visit Supplier Webpage Request for quotation
CAS: 1115-70-4
Tel: 18301782025
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Mobile: 18021002903
QQ: 3008007409

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View History

1,1-dimethylbiguanide hydrochloride

1,1-dimethylbiguanide hydrochloride Request for Quotation

Metformin HCL

CAS: 1115-70-4;15537-72-1

Molecular Formula: C4H12ClN5

1,1-dimethylbiguanide hydrochloride - Names and Identifiers

1,1-dimethylbiguanide hydrochloride - Physico-chemical Properties

1,1-dimethylbiguanide hydrochloride - Risk and Safety

1,1-dimethylbiguanide hydrochloride - Reference

1,1-dimethylbiguanide hydrochloride - Metformin Hydrochloride And Glibenclamide Tablets(Ⅰ) (I)

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trait

identification

examination

Content determination

category

storage

1,1-dimethylbiguanide hydrochloride - Standard

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1,1-dimethylbiguanide hydrochloride - Trait

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melting point

absorption coefficient

1,1-dimethylbiguanide hydrochloride - Introduction

1,1-dimethylbiguanide hydrochloride - Differential diagnosis

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1,1-dimethylbiguanide hydrochloride - Exam

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Related substances

loss on drying

ignition residue

Heavy metals

1,1-dimethylbiguanide hydrochloride - Content determination

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1,1-dimethylbiguanide hydrochloride - Category

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1,1-dimethylbiguanide hydrochloride - Storage

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1,1-dimethylbiguanide hydrochloride - Metformin Hydrochloride And Glibenclamide Tablets(Ⅰ) (II)

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trait

identification

examination

Content determination

category

storage

1,1-dimethylbiguanide hydrochloride - Metformin and glibenclamide capsules (I)

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trait

identification

examination

Content determination

category

storage

1,1-dimethylbiguanide hydrochloride - Metformin and glibenclamide capsules (II)

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trait

identification

examination

Content determination

category

storage

1,1-dimethylbiguanide hydrochloride - Metformin Hydrochloride Tablets

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trait

identification

examination

Content determination

category

specification

storage

1,1-dimethylbiguanide hydrochloride - Metformin hydrochloride enteric-coated tablets

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trait

identification

examination

Content determination

category

specification

storage

1,1-dimethylbiguanide hydrochloride - Metformin Hydrochloride Enteric-coated Capsules

1,1-dimethylbiguanide hydrochloride