1-(beta-Oxyethyl)-2-methyl-5-nitroimidazole
2-Methyl-5-nitroimidazole-1-ethanol
CAS: 443-48-1
Molecular Formula: C6H9N3O3
1-(beta-Oxyethyl)-2-methyl-5-nitroimidazole - Names and Identifiers
1-(beta-Oxyethyl)-2-methyl-5-nitroimidazole - Physico-chemical Properties
| Molecular Formula | C6H9N3O3 |
| Molar Mass | 171.15 |
| Density | 1.3994 (rough estimate) |
| Melting Point | 159-161 °C (lit.) |
| Boling Point | 301.12°C (rough estimate) |
| Flash Point | 9℃ |
| Water Solubility | <0.1 g/100 mL at 20 ºC |
| Solubility | Soluble in hot water, slightly soluble in ethanol, slightly soluble in water or chloroform, very slightly soluble in ethanol. It tastes bitter and slightly salty. |
| Vapor Presure | 2.67E-07mmHg at 25°C |
| Appearance | White to slightly yellow crystalline powder |
| Color | white to light yellow |
| Merck | 14,6157 |
| BRN | 611683 |
| pKa | pKa 2.62(H2O,t =25±0.2,Iundefined) (Uncertain) |
| Storage Condition | 2-8°C |
| Stability | Stable. Incompatible with strong oxidizing agents. |
| Refractive Index | 1.5800 (estimate) |
| MDL | MFCD00009750 |
| Physical and Chemical Properties | Melting Point -163°C water-soluble <0.1g/100 mL at 20°C |
| Use | For the treatment of amoebiasis, trichomoniasis and anaerobic infections |
1-(beta-Oxyethyl)-2-methyl-5-nitroimidazole - Risk and Safety
| Hazard Symbols | Xn - Harmful |
| Risk Codes | R40 - Limited evidence of a carcinogenic effect R46 - May cause heritable genetic damage R45 - May cause cancer R39/23/24/25 - R23/24/25 - Toxic by inhalation, in contact with skin and if swallowed. R11 - Highly Flammable |
| Safety Description | S36/37 - Wear suitable protective clothing and gloves. S45 - In case of accident or if you feel unwell, seek medical advice immediately (show the label whenever possible.) S53 - Avoid exposure - obtain special instructions before use. S16 - Keep away from sources of ignition. S7 - Keep container tightly closed. |
| WGK Germany | 3 |
| RTECS | NI5600000 |
| FLUKA BRAND F CODES | 8 |
| HS Code | 29332990 |
1-(beta-Oxyethyl)-2-methyl-5-nitroimidazole - Reference
| Reference Show more | 1. Liu Xiaoxue, Zhang Xiaolin, Liu Songling, etc. Clearance of intestinal microflora in rats by combined use of intestinal lavage fluid and antibiotics [J]. China dairy cow, 2018, 000(003):1-4. 2. Zhang Shixin, Peng Litao, Fan Ming, et al. Screening of active compounds inhibiting Penicillium cinerea of postharvest pear fruit from clinical medicine [J]. Food science 2020 41(5). 3. Wu Qin, Xu Ziyang, Liu Liping, etc. Role of gut microbiota in stress-induced hypertension in rats [J]. Biotechnology Bulletin, 2020, v.36;No.331(02):88-95. 4. Wei Wenzeng, Zhao Ningning, Lin Yingyan, Wang Jin, Wang Gong. Evaluation of the effect of ethanol extract of Antrodia camphorata on the activity of human CYP450 by Cocktail probe [J]. Science and Technology Wind, 2021(03):139-140. 5. Wei Wenzeng, Zhao Ningning, Lin Yingyan, Wang Jin, Wang Gong. Evaluation of the effect of ethanol extract of Antrodia camphorata on the activity of human CYP450 by Cocktail probe [J]. Science and Technology Wind, 2021(03):139-140. 6. Yao, Ye, et al. "Berberine alloys type 2 diabetic syndromes by altering gut microbiota and reducing aromatic amino acids." Biomedicine & Pharmacotherapy 131 (2020): 110669.https://doi.org/10.1016/j.biopha.2020.110669 7. [IF=0] Pang Liang et al."Protective effect of liensinine on periodontitis through its antioxidant effect in mice."J Korean Soc Appl Bi. 2015 Dec;58(6):927-936 8. [IF=10.588] Lingyu Li et al."AuNPs/NiFe-LDHs-assisted laser desorption/ionization mass spectrometry for efficient analysis of metronidazole and its metabolites in water samples."J Hazard Mater. 2022 Feb;423:126893 9. [IF=6.475] Chunjun Li et al."Colon and gut microbiota greatly affect the absorption and utilization of astaxanthin derived from Haematococcus pluvialis."FOOD RESEARCH INTERNATIONAL. 2022 Jun;156:111324 |
1-(beta-Oxyethyl)-2-methyl-5-nitroimidazole - Standard
Authoritative Data Verified Data
This product is 2-methyl-5-nitroimidazole-1-ethanol. The content of C6H9N303 shall not be less than 99.0% calculated as per dry product.
Last Update：2024-01-02 23:10:35
1-(beta-Oxyethyl)-2-methyl-5-nitroimidazole - Trait
Authoritative Data Verified Data
- This product is a white to yellowish crystal or crystalline powder; There is a slight odor.
- This product is slightly soluble in ethanol, slightly soluble in water or chloroform, and slightly soluble in ether.
melting point
The melting point of this product (General 0612) is 159~163°C.
absorption coefficient
take this product, precision weighing, and hydrochloric acid solution (9-1000) dissolved and quantitatively diluted into about 13ug solution per lml, the absorbance was measured at a wavelength of 277nm according to ultraviolet-visible spectrophotometry (General rule 0401), and the absorption coefficient was 365 to 389.
Last Update：2022-01-01 11:38:21
1-(beta-Oxyethyl)-2-methyl-5-nitroimidazole - Differential diagnosis
Authoritative Data Verified Data
- take about 10mg of this product, add 2ml of sodium hydroxide test solution at a slight temperature to obtain a purple-red solution; Add dilute hydrochloric acid Dropwise to make it acidic and turn yellow, and add excess sodium hydroxide Dropwise to turn it into orange-red.
- take about 0.1g of this product, add sulfuric acid solution (3-100)4ml, should be able to dissolve; Add 10ml of trinitrophenol test solution, and then generate yellow precipitate.
- the solution under the term of absorption coefficient has the maximum absorption at the wavelength of 277nm as determined by ultraviolet-visible spectrophotometry (General rule 0401), there is minimal absorption at a wavelength of 241NM.
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 112).
Last Update：2022-01-01 11:38:22
1-(beta-Oxyethyl)-2-methyl-5-nitroimidazole - Exam
Authoritative Data Verified Data
clarity and color of ethanol solution
take this product, dissolve and dilute with ethanol to make a solution containing about 5mg per 1 ml, and the solution should be clear; If it is turbid, compare it with No. 1 turbidity standard solution (General rule 0902 first method), shall not be more concentrated; If the color is developed, it shall not be deeper in comparison with the yellow or yellow-green No. 2 Standard Colorimetric solution (General Principles 0901 first method).
Related substances
operation in the dark. Take this product about lOOmg, put it in a 100ml measuring flask, add methanol to dissolve and dilute to the scale, shake well, take an appropriate amount of precision, quantitatively dilute with mobile phase to make a solution containing 0.2mg per lml, as a test solution; Another 2-methyl-5-nitroimidazole (impurity I) control sample of about 20mg, 100ml flask, methanol dissolved and diluted to the scale, shake, 2ml of test solution and 1ml of control solution were accurately measured and placed in the same 100ml measuring flask, diluted to the scale with mobile phase, shaken, and 5ml was accurately measured, in a 50INL volumetric flask, dilute to the scale with the mobile phase, and shake to serve as a control solution. According to the high performance liquid chromatography (General rule 0512) test, silica gel bonded with eighteen alkyl silane was used as the filler; Methanol-water (20:80) was used as the mobile phase; The detection wavelength was 315nm. 20ul of the control solution is injected into the human liquid chromatograph, and the chromatogram is recorded. The number of theoretical plates is not less than 2000 based on the metronidazole peak, and the separation degree of metronidazole peak and impurity I peak should be greater than 2.0. 20 u1 of the test solution and the control solution were respectively injected into the human liquid chromatograph, and the chromatogram was recorded to 2 times of the retention time of the main component peak. If there is a chromatographic peak in the chromatogram of the test solution that is consistent with the retention time of impurity I peak in the control solution, the peak area shall not be greater than 0.5 times (0.1%) of the peak area of metronidazole in the control solution; the sum of the peak areas of each impurity should not be larger than the area of metronidazole peak in the ten Control Solutions (0.2%).
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
take this product 1.Og, check according to law (General rule 0841), residue shall not exceed 0.1%.
Heavy metals
The residue left under the item of taking the ignition residue shall not contain more than 10 parts per million of heavy metal when examined by law (General Principles 0821, Law II).
Last Update：2022-01-01 11:38:23
1-(beta-Oxyethyl)-2-methyl-5-nitroimidazole - Content determination
Authoritative Data Verified Data
take this product about 0.13g, precision weighing, add glacial acetic acid 10ml dissolved, add naphthol benzyl alcohol indicator solution 1 drop, with high gas acid titration solution (0.1 mol/L) titration to the solution is green, and the result of the titration is corrected with a blank test. Each 1 ml of perchloric acid titration solution (0.1 mol/L) corresponds to 17.12mg of c6h9n303.
Last Update：2022-01-01 11:38:23
1-(beta-Oxyethyl)-2-methyl-5-nitroimidazole - Category
Authoritative Data Verified Data
Anti-anaerobic drugs, anti-trichomonal drugs.
Last Update：2022-01-01 11:38:23
1-(beta-Oxyethyl)-2-methyl-5-nitroimidazole - Storage
Authoritative Data Verified Data
light shielding, sealed storage.
Last Update：2022-01-01 11:38:23
1-(beta-Oxyethyl)-2-methyl-5-nitroimidazole - Metronidazole tablets
Authoritative Data Verified Data
This product contains metronidazole (C6H9N303) should be labeled the amount of 93.0% ~ 107.0%.
trait
This product is white or off-white.
identification
- take an appropriate amount of fine powder of this product (approximately equivalent to 10 mg of metronidazole) and show the same reaction according to item (1) of identification under metronidazole.
- take an appropriate amount of fine powder of this product (about 0.2g of metronidazole), add 4ml of sulfuric acid solution (3-100), shake to dissolve metronidazole, filter, Add 10 ml of trinitrophenol test solution to the filtrate, after placement, a yellow precipitate was generated.
- 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
- dissolution dissolution of this product, according to the dissolution and release determination method (General rule 0931 The first method), hydrochloric acid solution (9-100) as the dissolution medium, the speed is rpm, operate according to the law, after 30 minutes, take the solution, filter, take the filtrate 3ml, put it in a 50ml measuring flask, dilute it to the scale with dissolution medium, shake it well, the absorbance was measured at a wavelength of 277nm according to ultraviolet-visible spectrophotometry (General rule 0401), and the elution amount of each tablet was calculated as the absorption coefficient of C6H9N303 was 377. The limit is 80% 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
- measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica gel as filler; Methanol-water (20:80) as mobile phase; The detection wavelength was 320nm. The number of theoretical plates is not less than 2000 based on the metronidazole peak.
- determination Method: Take 20 tablets of this product, precise weighing, fine grinding, precise weighing to take an appropriate amount of fine powder (about 0.25g of metronidazole), put it in a 50ml measuring flask, and add an appropriate amount of 50% methanol, shake to dissolve metronidazole, dilute to the scale with 50% methanol, shake well, filter, Take 5ml of continued filtrate precisely, put it in a measuring flask, dilute to the scale with mobile phase, shake well, as a sample solution, take 10 u1 for precision measurement, inject it into liquid chromatograph, record chromatogram; Take appropriate amount of metronidazole reference substance for precision weighing, the mobile phase was added to dissolve and quantitatively dilute to prepare a solution containing about 0.25mg per 1 ml, which was determined by the same method. According to the external standard method to calculate the peak area, that is.
category
Same as metronidazole.
specification
(1)0.lg (2)0.2g (3)0.25g
storage
light shielding, sealed storage.
Last Update：2022-01-01 11:38:24
1-(beta-Oxyethyl)-2-methyl-5-nitroimidazole - Metronidazole Vaginal Effervescent Tablets
Authoritative Data Verified Data
This product contains metronidazole (C6H9N303) should be labeled the amount of 93.0% ~ 107.0%.
trait
This product is white or off-white, with slight opacities on the surface.
identification
- take an appropriate amount of fine powder of this product (about 10mg of metronidazole), and show the same reaction according to the identification (1) Test under the item of metronidazole.
- 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 acidity of 5 tablets of this product, ground, 50TNL water, stirring to dissolve metronidazole, according to the law (General 0631),pH value should be 4.0~5.5.
- foaming volume: Take 10 test tubes filled with 25ml plugs (about 1.5 in inner diameter), add 2ml of water to each precision, place them in 37°C ± 1°C water bath for 5 minutes, one piece of the human product was injected into each tube for 20 minutes, and the volume of the maximum foaming amount was observed. The average volume should be not less than 10.0, and less than 6.0ml should not exceed 2 pieces.
- In addition to not checking the disintegration time, the relevant provisions under the item of tablets (General rule 0101) should be met.
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; Methanol-water (20:80) as mobile phase; The detection wavelength was 320nm. The number of theoretical plates is not less than 2000 based on the metronidazole peak.
- determination Method: Take 20 tablets of this product, precise weighing, fine grinding, precise weighing to take an appropriate amount of fine powder (about 0.25g of metronidazole), put it in a 50ml measuring flask, and add an appropriate amount of 50% methanol, shake to dissolve metronidazole, dilute to the scale with 50% methanol, shake well, filter, Take 5ml of continued filtrate precisely, put it in a measuring flask, dilute to the scale with mobile phase, shake well, as a sample solution, take lOul for precise measurement, inject human liquid chromatograph, record chromatogram; Take appropriate amount of metronidazole reference substance for precise weighing, the mobile phase was added to dissolve and quantitatively dilute to prepare a solution containing about 0.25mg per 1 ml, which was determined by the same method. According to the external standard method to calculate the peak area, that is.
category
Same as metronidazole.
specification
0.2g
storage
shade, seal, and store in a cool and dry place.
Last Update：2022-01-01 11:38:25
1-(beta-Oxyethyl)-2-methyl-5-nitroimidazole - Metronidazole injection
Authoritative Data Verified Data
This product is metronidazole and sodium chloride appropriate amount to make into isotonic sterile aqueous solution. The content of metronidazole (C6H9N303) shall be between 93.0% and 107.0% of the labeled amount.
trait
This product is colorless to yellowish clear liquid.
identification
- take an appropriate amount of this product (approximately equivalent to metronidazole O.lg), set in a separatory funnel, add 9g of sodium chloride, shake, add 20ml of acetone, shake, let stand and layer, take the upper layer of solution to dry, take the residue to determine the infrared absorption spectrum (General 0402) should be consistent with the control spectrum (Spectrum set 112 Figure).
- 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.
- This product shows the reaction of sodium salt identification (1) and chloride identification (1) (General rule 0301).
examination
- the pH value should be 4.5 to 7.0 (General 0631). Appropriate amount of the product is diluted with water to make a solution containing about 0.2 mg of metronidazole per 1ml, which is used as a test solution; Another reference substance of impurity I is about 20mg, which is placed in a 100ml measuring flask, add methanol to dissolve and dilute to the scale, shake well, as a reference solution; Respectively, precision take 2ml of test solution and 1ml of reference solution, put in the same 100ml measuring flask, dilute to the scale with mobile phase, shake, Take 5ml with precision, put it in a 50ml measuring flask, dilute to the scale with mobile phase, shake well, and use as a control solution. According to the method of metronidazole related substances. If there is a peak in the chromatogram of the test solution that is consistent with the retention time of impurity I, the peak area shall not be greater than 2.5 times (0.5%) of the metronidazole peak area in the control solution; the sum of the peak areas of other impurities shall not be greater than 2.5 times (0.5%) of the peak area of metronidazole in the control solution.
- nitride precision take 10ml of this product, add water to 50ml, add 2% dextrin solution 5ml, calcium carbonate 0.lg and fluorescent yellow indicator solution 5~8 drops, shake, with silver nitrate titration solution (0.lmol/L) titration to turbid liquid from yellow-green to reddish. Consumption of silver nitrate titration solution (0.lmol/L) should be 13.2~14.6ml.
- the bacterial endotoxin of this product is taken and checked according to law (General rule 1143). The amount of endotoxin contained in metronidazole per 1 mg should be less than 0.35EU.
- sterile take this product, by membrane filtration method, inspection according to law (General 1101), should comply with the provisions.
- others should comply with the relevant provisions under injection (General 0102).
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; Methanol-water (20:80) as mobile phase; The detection wavelength was 320mn. The number of theoretical plates is not less than 2000 based on the metronidazole peak.
- determination precision: take an appropriate amount of this product, quantitatively dilute it with mobile phase to prepare a solution containing about 0.25mg of metronidazole per lml, shake well, and use it as a test solution. Take 10 u1 for precision measurement, note human liquid chromatograph, record chromatogram; Take appropriate amount of metronidazole reference substance, accurately weigh, add mobile phase to dissolve and quantitatively dilute to make a solution containing about 0.25mg per lml, and determine with the same method. According to the external standard method to calculate the peak area, that is.
category
Same as metronidazole.
specification
(l)10ml:50mg (2 )20ml:lOOmg
storage
light shielding, closed storage.
Last Update：2022-01-01 11:38:26
1-(beta-Oxyethyl)-2-methyl-5-nitroimidazole - Metronidazole Suppositories
Authoritative Data Verified Data
This product contains metronidazole (C6H9N303) should be labeled the amount of 93.0% ~ 107.0%.
trait
This product is milky white to light yellow fat-soluble suppository.
identification
- take 1 capsule of this product, add 20ml of ethanol, place it on a water bath and heat it to melt, let it cool, solidify the matrix, filter it, and let the filtrate dry on the water bath, the residue showed the same reaction according to the identification (1) Test under the item of metronidazole.
- 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
should comply with the relevant provisions under suppository (General rule 0107).
Content determination
- measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica as filler; Methanol-water (20:80) as mobile phase; The detection wavelength was 320mn, the number of theoretical plates is not less than 2000 based on the metronidazole peak.
- determination Method: Take 10 capsules of this product, weigh them accurately, cut them into fragments, weigh an appropriate amount (about 25mg of metronidazole), put them in a 100ml measuring flask, and add an appropriate amount of mobile phase, after heating in a hot water bath to dissolve metronidazole, cool it, dilute it to scale with mobile phase, cool it in an ice bath for 1 hour, take it out and filter it immediately, then take the filtrate and let it go to room temperature as a test solution, lOul was accurately measured and injected into human liquid chromatograph, and the chromatogram was recorded. Another appropriate amount of metronidazole reference substance was accurately weighed, dissolved and quantitatively diluted with mobile phase to prepare a solution containing about 0.25mg per lml, which was determined by the same method. According to the external standard method to calculate the peak area, that is.
category
Same as metronidazole.
specification
(1)0.5g (2)lg
storage
light shielding, sealing, and storage at 30°C or lower.
Last Update：2022-01-01 11:38:27
1-(beta-Oxyethyl)-2-methyl-5-nitroimidazole - Metronidazole capsules
Authoritative Data Verified Data
This product contains metronidazole (C6H9N303) should be labeled the amount of 93.0% ~ 107.0%.
trait
The content of this product is white to yellowish powder.
identification
- take an appropriate amount of the content of this product (about 1mg of metronidazole), add 2ml of sodium hydroxide solution, slightly warm, that is, a purple solution, Dropwise adding dilute hydrochloric acid to make it acidic and then turn yellow, after adding excess sodium hydroxide solution, it turned orange-red.
- take an appropriate amount of the content of this product (about 0.lg of metronidazole), add 4ml of 0.5mol/L sulfuric acid solution, shake to dissolve metronidazole, filter, and add 10ml of trinitrophenol test solution to the filtrate, after placement, a yellow precipitate was generated.
- 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
- dissolution dissolution of this product, according to the dissolution and release determination method (General rule 0931 The first method), hydrochloric acid solution (9-100) as the dissolution medium, the speed is rpm, operate in accordance with the law, after 30 minutes, take the solution to filter, take a precise amount of filtrate 3ml, put it in a 50ml measuring flask, dilute to the scale with dissolution medium, shake, the absorbance was measured at a wavelength of 277nm according to UV-Vis spectrophotometry (General 0401), and the amount of dissolution per particle was calculated as the absorption coefficient of CsH9N303 was 377. The limit is 80% 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
- measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica gel as filler; Methanol-water (20:80) as mobile phase; The detection wavelength was 320mn. The number of theoretical plates is not less than 2000 based on the metronidazole peak.
- determine the contents under the item of difference in loading amount, mix evenly, weigh an appropriate amount (about 0.25g of metronidazole) accurately, put it in a 50ml measuring flask, and add an appropriate amount of 50% methanol, shake to dissolve metronidazole, dilute to the scale with 50% methanol, shake well, filter, Take 5ml of continued filtrate precisely, put it in a measuring flask, dilute to the scale with mobile phase, shake well, as the sample solution, 1 u1 was accurately measured and injected into the liquid chromatograph to record the chromatogram, the mobile phase was added to dissolve and quantitatively dilute to prepare a solution containing about 0.25mg per 1 ml, which was determined by the same method. According to the external standard method to calculate the peak area, that is.
category
Same as metronidazole.
specification
(1)0.2g (2)0.4g
storage
light shielding, sealed storage.
Last Update：2022-01-01 11:38:28
1-(beta-Oxyethyl)-2-methyl-5-nitroimidazole - Metronidazole and Glucose Injection
Authoritative Data Verified Data
This product is a sterile aqueous solution of metronidazole and glucose. The contents of metronidazole (C6H9N304) and glucose (C6H1206 • H20) should be between 95.0% and 105.0% of the labeled amount.
trait
This product is colorless to yellowish clear liquid.
identification
- take 50ml of this product, heat and evaporate to about 8ml, let it cool, place it in the refrigerator to precipitate crystals, filter, wash the crystals with a small amount of water for 3 times, and transfer it to a small beaker, the same response was shown in the identification (1) Test under metronidazole.
- take 5ml of this product and slowly drop the warm alkaline copper tartrate solution to generate red precipitate of cuprous oxide.
- 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 in the chromatogram recorded under the item containing the child.
examination
- the pH value should be 4.5 to 6.0 (General 0631).
- appropriate amount of related substances: dilute with water to prepare a solution containing about 0.2mg of metronidazole per 1 ml, which is used as a test solution; Take about 20mg of reference substance for impurity I and place it in a 100ml measuring flask, add methanol to dissolve and dilute to the scale, shake well, as a reference solution; Respectively, take 2ml of the test solution and 1 ml of the reference solution, put in the same 100ml measuring flask, dilute to the scale with mobile phase, shake well, take 5ml, put it in a 50ml measuring flask, dilute to the scale with mobile phase, shake well, and use as a control solution. If there is a chromatographic peak in the chromatogram of the test solution consistent with the retention time of the impurity I, it shall be determined according to the method for the related substances of metronidazole, the peak area shall not be greater than 2.5 times (0.5%) of the metronidazole peak area in the control solution; Except for the 5-hydroxymethylfurfural peak, the sum of the peak areas of other impurities shall not be greater than 2.5 times (0.5%) of the peak area of metronidazole in the control solution.
- S • hydroxymethylfurfural take this product as a test solution; Take the appropriate amount of 5-hydroxymethylfurfural reference, precision weighing, water was added to dissolve and quantitatively diluted to prepare a solution containing about 10ug per 1 ml as a control solution. An appropriate amount of the impurity I control and the 5-hydroxymethylfurfural control were separately taken, dissolved by adding water and diluted to prepare a solution containing 10ug each in 1 ml as a system applicable solution. According to the chromatographic conditions under the content determination item, in addition to the detection wavelength of 284nm, 20ul of the system applicable solution is injected into the liquid chromatograph. The separation degree between the 5-hydroxymethyl furfural peak and the impurity I peak shall meet the requirements. 20 u1 of the test solution and the reference solution were respectively injected into the liquid chromatograph, and the chromatograms were recorded. If there are chromatographic peaks in the chromatogram of the test solution that are consistent with the retention time of 5-hydroxymethylfurfural, the peak area shall be calculated according to the external standard method, and 0.02% of the labeled amount of glucose shall not be passed.
- osmolality this product shall be taken and checked according to law (General rule 0632). The osmolality ratio shall be 0.9-1.1.
- take an appropriate amount of heavy metal (equivalent to 3g of glucose), put it on a water bath and evaporate it to about 20ml, let it cool, add 2ml of acetate buffer (pH 3.5) and an appropriate amount of water to make it 25ml, inspection according to law (General Principles 0821, law I), containing heavy metals shall not exceed 5 parts per million.
- bacterial endotoxin this product, according to the law to check (General 1143), the amount of endotoxin per lml should be less than 0.50EU.
- sterile take this product, by membrane filtration method, inspection according to law (General 1101), should comply with the provisions.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
- metronidazole 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-water (20:80) as mobile phase; The detection wavelength was 320nm. The number of theoretical plates is not less than 2000 based on the metronidazole peak.
- determination precision: take an appropriate amount of this product, quantitatively dilute it with mobile phase to prepare a solution containing about 0.25mg of metronidazole per 1 ml, shake well, and use it as a test solution, note human liquid chromatograph, record chromatogram; Take appropriate amount of metronidazole reference substance, accurately weigh, add mobile phase to dissolve and quantitatively dilute to make a solution containing about 0.25mg per lml, and determine with the same method. According to the external standard method to calculate the peak area, that is.
- glucose the optical rotation was measured at 25 ° C. According to the law (General rule 0621), and multiplied by 2.0852 to obtain a Weight (g) containing C6H1206 · H20 in the Test amount.
category
Same as metronidazole.
specification
(l)lOOml: metronidazole 0.2g with glucose 5g (2)250ml metronidazole 0.5g with glucose 12.5g
storage
light shielding, closed storage.
Last Update：2022-01-01 11:38:29
1-(beta-Oxyethyl)-2-methyl-5-nitroimidazole - MetronidazoleandSodiumChlorideInjection
Authoritative Data Verified Data
This product is a sterile aqueous solution of metronidazole and sodium chloride. The contents of metronidazole (C6H9N303) and sodium chloride (NaCl) should be between 93.0% and 107.0% of the labeled amount.
trait
This product is colorless to yellowish clear liquid.
identification
- take an appropriate amount of this product (approximately equivalent to metronidazole O.lg), set in a separatory funnel, add 9g of sodium chloride (containing 5mg of metronidazole per lml) or 22G (containing 2mg of metronidazole per lml), shake, add 20ml of acetone (5mg of metronidazole per lml) or 50ml (2mg of metronidazole per lml), shake, let stand and layer, take the upper layer of solution to dry, take the residue to determine the infrared absorption spectrum (General 0402), should be consistent with the control spectrum (Spectrum set 112 Figure).
- 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.
- This product sodium salt identification (1) reaction and chloride identification (1) reaction (General rule 0301).
examination
- the pH value should be 4.5 to 7.0 (General 0631).
- appropriate amount of related substances: dilute with water to prepare a solution containing about 0.2mg of metronidazole per 1 ml, which is used as a test solution; Take about 20mg of reference substance for impurity I and place it in a 100ml measuring flask, add methanol to dissolve and dilute to the scale, shake well, as a reference solution; Respectively, take 2ml of the test solution and 1 ml of the reference solution, put in the same 100ml measuring flask, dilute to the scale with mobile phase, shake, Take 5ml with precision, put it in a 50ml measuring flask, dilute to the scale with mobile phase, shake well, and use as a control solution. According to the method of metronidazole related substances. If there is a peak in the chromatogram of the test solution that is consistent with the retention time of impurity I, the peak area shall not be greater than 2.5 times (0.5%) of the metronidazole peak area in the control solution; the sum of the peak areas of other impurities shall not be greater than 2.5 times (0.5%) of the peak area of metronidazole in the control solution.
- osmolality the osmolality shall be 0632-260 m0smol/kg for inspection according to law (General rule 340).
- bacterial endotoxin this product, according to the law to check (General 1143), the amount of endotoxin per lml should be less than 0.50EU.
- sterile take this product, by membrane filtration method, inspection according to law (General 1101), should comply with the provisions.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
- metronidazole 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-water (20:80) as mobile phase; The detection wavelength was 320nm. The number of theoretical plates is not less than 2000 based on the metronidazole peak.
- determination precision: take an appropriate amount of this product, quantitatively dilute it with mobile phase to prepare a solution containing about 0.25mg of metronidazole per 1 ml, shake well, and use it as a sample solution, and take 10ul of precision measurement, note human liquid chromatograph, record chromatogram; Take appropriate amount of metronidazole reference substance, accurately weigh, add mobile phase to dissolve and quantitatively dilute to make a solution containing about 0.25mg per lml, and determine with the same method. According to the external standard method to calculate the peak area, that is.
- sodium chloride precision measure 10ml of this product, add water to 50ml, add 2% dextrin solution 5ml, calcium carbonate 0.lg and fluorescent yellow indicator solution 5~8 drops, shake, with silver nitrate titration solution (0.lmol/L) titration to turbid liquid from yellow-green to reddish. Each 1 ml of silver nitrate titration solution (0.1 mol/L) corresponds to 5.844mg of NaCl.
category
Same as metronidazole.
specification
- 100ml: metronidazole 0.5g and sodium chloride 0.8g
- l00ml: metronidazole 0.5g with sodium chloride 0.9g
- 250ml: metronidazole 0.5g with sodium chloride 2.25g
- 250ml metronidazole 1.25g with sodium chloride 2.0g
storage
light shielding, closed storage.
Last Update：2022-01-01 11:38:30
1-(beta-Oxyethyl)-2-methyl-5-nitroimidazole - Metronidazole gel
Authoritative Data Verified Data
This product contains metronidazole (C6H9N303) should be the mark of 93.0% ~ 107.0%.
trait
This product is a light yellow transparent gel.
identification
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 control solution.
examination
- acidity: take 5g of this product, add 40ml of water, stir for 30 minutes, and measure according to law (General rule 0631). The pH value should be 4.0~6. 5.
- microbial limit take this product as non-sterile product microbial limit test: microbial count method (General 1105) and control bacteria test method (General 1106) and non sterile drugs microbial limit standard (General 1107) inspection, should meet the requirements.
- others shall comply with the relevant provisions under the item of gel (General rule 0114).
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; Methanol-water (20:80) as mobile phase; The detection wavelength was 320mn. The number of theoretical plates shall not be less than 20000 Based on the calculation of metronidazole peak.
- determination method: take an appropriate amount of this product (about 25mg of metronidazole), weigh it accurately, put it in a 100ml measuring flask, and add diluent [methanol-phosphate buffer solution (take potassium dihydrogen phosphate 4.28g and disodium hydrogen phosphate 3.17g), add water to dissolve into 1000ml)(65:35)] appropriate amount, sonicate to dissolve metronidazole, dilute to the scale with the above diluent, shake, filter, and take the continued filtrate as the test solution, A sample of 10ul was obtained by injection, and the chromatogram was recorded. An appropriate amount of metronidazole reference substance was obtained, which was accurately weighed, dissolved and quantitatively diluted with diluent to prepare a solution containing about 0.25mg per lml, which was determined by the same method. According to the external standard method to calculate the peak area, that is.
category
Same as metronidazole.
specification
(l)10g:75mg (2)20g:150mg
storage
light shielding, sealed storage.
Last Update：2022-01-01 11:38:31
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