Dipicin
rifampicin
CAS: 13292-46-1
Molecular Formula: C43H58N4O12
Dipicin - Names and Identifiers
Dipicin - Physico-chemical Properties
| Molecular Formula | C43H58N4O12 |
| Molar Mass | 822.94 |
| Density | 1.1782 (rough estimate) |
| Melting Point | 183°C (dec.) |
| Boling Point | 761.02°C (rough estimate) |
| Flash Point | 520.7°C |
| Water Solubility | Soluble in DMSO or methanolSoluble in water, ethyl acetate, chloroform, methanol, tetrahydrofuran and dimethyl sulfoxide. |
| Solubility | H2O: 1.3 mg/mL (pH 4.3);DMSO: 100 mg/mL;H2O: 2.5 mg/mL at 25°C (pH 7.3). Easily soluble in chloroform, ethyl acetate, methanol, |
| Vapor Presure | 0mmHg at 25°C |
| Appearance | faintly orange to red-brown(powder) |
| Color | faint red to very dark red |
| Merck | 14,8216 |
| BRN | 5723476 |
| pKa | 1.7, 7.9(at 25℃) |
| Storage Condition | 2-8°C |
| Stability | Hygroscopic, Light Sensitive |
| Refractive Index | 1.6000 (estimate) |
| MDL | MFCD00151389 |
| Physical and Chemical Properties | Melting point 183°C (dec.) |
| Use | Has a broad-spectrum antibacterial effect, gram-positive cocci, Mycobacterium tuberculosis has good antibacterial activity, the same antibacterial spectrum and rifampicin |
Dipicin - Risk and Safety
| Risk Codes | R22 - Harmful if swallowed R36/37/38 - Irritating to eyes, respiratory system and skin. R36/38 - Irritating to eyes and skin. |
| Safety Description | S26 - In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. S36 - Wear suitable protective clothing. S37/39 - Wear suitable gloves and eye/face protection |
| WGK Germany | 3 |
| RTECS | VJ7000000 |
| FLUKA BRAND F CODES | 8-10-21 |
| HS Code | 29419000 |
| Toxicity | LD50 in mice, rats (mg/kg): 885, 1720 orally; 260, 330 i.v.; 640, 550 i.p. (Fürész) |
Dipicin - Upstream Downstream Industry
| Raw Materials | Sulfuric acid |
Dipicin - Reference
| Reference Show more | 1. Wang Qiang, Dong Jie, Yi, Ye Jiacao, et al. In vivo and in vitro experiments to explore the effects of tannins in Galla Chinensis on the pharmacokinetics of rifampicin [J]. Chinese Journal of Traditional Chinese Medicine 2018 43(22):170-175. 2. Han Long, Ruan Guoxiang, Ma Jiexi, et al. Chemical mutagenesis and antibiotic resistance screening of vitamin B12 producing bacteria [J]. Fine and special chemicals, 2019, 27(01):40-43. 3. Ye Xiaoli, Wang Ling, Jiang Xuehua. Protective effect and mechanism of anethyl trisulfide on rifampicin-induced liver injury [J]. Huaxi Journal of Pharmacy, 2018(5):501-503. 4. Zhou Qing. Structure Analysis and Related Gene Study of Lipid A of Vibrio parahaemolyticus [D]. Jiangnan university, 2020. 5. Liu, Xiang, et al. "Lecithin doped electrospun poly (lactic acid)-thermoplastic polyurethane fibers for hepatocyte viability improvement." Colloids and Surfaces B: Biointerfaces 175 (2019): 264-271.https://doi.org/10.1016/j.colsurfb. 2018.09.069 6. [IF=5.268] Xiang Liu et al."Lecithin doped electrospun poly(lactic acid)-thermoplastic polyurethane fibers for hepatocyte viability improvement."Colloid Surface B. 2019 Mar;175:264 7. [IF=1.914] Ma Gang et al."Assessment of the Inhibitory Effect of Rifampicin on Amyloid Formation of Hen Egg White Lysozyme: Thioflavin T Fluorescence Assay versus FTIR Difference Spectroscopy."J Spectrosc. 2014;2014:285806 8. [IF=5.542] Yujie Yang et al."Tanshinone IIA prevents rifampicin‐induced liver injury by regulating BSEP/NTCP expression via epigenetic activation of NRF2."Liver Int. 2020 Jan;40(1):141-154 9. [IF=3.84] Li Qiao et al."Mitochondrial membrane potential played crucial roles in the accumulation of berberine in HepG2 cells."Bioscience Rep. 2019 Apr;39(4):BSR20190477 10. [IF=2.067] Y Yang et al."Tanshinone ⅡA may alleviate rifampin-induced cholestasis by regulating the expression and function of NTCP:."Hum Exp Toxicol. 2020;40(6):1003-1011 11. [IF=3.631] Zhiya Yang et al."5-aminolevulinic acid-photodynamic therapy ameliorates cutaneous granuloma by killing drug-resistant Mycobacterium marinum."Photodiagn Photodyn. 2022 Mar;:102839 12. [IF=4.098] Jie Liang et al."Deep learning aided quantitative analysis of anti-tuberculosis fixed-dose combinatorial formulation by terahertz spectroscopy."Spectrochim Acta A. 2022 Mar;269:120746 13. [IF=7.171] Zhengzheng Cao et al."Phenotypic and Genotypic Characterization of Multidrug-Resistant Enterobacter hormaechei Carrying qnrS Gene Isolated from Chicken Feed in China | Microbiology Spectrum."Microbiology Spectrum. 2022 Apr ;: |
Dipicin - Standard
Authoritative Data Verified Data
This product is 3-[[(4-methyl-1-piperazinyl) imino] methyl] rifamycin. The content of rifampicin (C43H58N4012) shall be 97.0% ~ 102.0% calculated as dry product.
Last Update：2024-01-02 23:10:35
Dipicin - Trait
Authoritative Data Verified Data
- This product is bright red or dark red crystalline powder. Odorless.
- This product is dissolved in methanol and almost insoluble in water.
Last Update：2022-01-01 11:58:02
Dipicin - Differential diagnosis
Authoritative Data Verified Data
- take about 10mg of this product, Add 10ml of methanol to dissolve, take 1 ml, dilute with phosphate buffer (pH 7.0) to make a solution containing about 20mg per 1 ml, as determined by UV-Vis spectrophotometry (General rule 0401), there is maximum absorption at wavelengths of 237nm, 254nm.334nm and 473nm, and minimum absorption at wavelengths of 296nm and 394nm.
- take the appropriate amount of this product and the reference substance of rifampicin, respectively add methanol to dissolve and dilute to prepare a solution containing about 10 mg per 1 ml as the test solution and the reference solution; A mixed solution containing about 10 mg of rifampicin and 10 mg of rifapentine per 1 ml was prepared by dissolving and diluting the rifampicin and rifapentine in appropriate amounts with methanol. According to the thin layer chromatography (General 0502) test, absorb the above three solutions each 2 u1, respectively, on the same silica gel G thin layer plate, with ethyl acetate-methanol-concentrated ammonia solution (8:2:0.2) for the development of the agent, expand, dry, view under sunlight. System suitability solution the rifampin and rifapentine spots should be completely separated. The position and color of the main spot displayed by the test solution should be consistent with the position and color of the main spot of the reference solution.
- 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.
- The infrared absorption spectrum of this product should be consistent with the spectrum of the control (Spectrum set 198) or the reference (I or II crystal form) (General 0402).
- two items (2) and (3) above can be selected as one item.
Last Update：2022-01-01 11:58:03
Dipicin - Exam
Authoritative Data Verified Data
crystallinity
take a small amount of this product, according to the law inspection (General 0981), should comply with the provisions.
acidity
take this product, add water to make a suspension containing about 10 mg per lml, according to the law (General 0631), the pH value should be 4.0~6.5.
Related substances
ready-to-use fresh or stored at 2 to 8°C for use within 6 hours. Take an appropriate amount of this product, weigh it accurately, add a small amount of acetonitrile (about 10 mg plus lml) and dissolve it, then use acetonitrile-water (1:1). Quantitative dilution is made into a solution containing about 1 mg per 1 ml, which is used as the test solution; An appropriate amount of rifampicin reference substance is accurately weighed, and a small amount of acetonitrile (about 10 mg plus 1 ml of acetonitrile) is added for dissolution, then dilute quantitatively with acetonitrile-water (1:1) to prepare a solution containing about 10ug per 1 ml as a control solution; Take an appropriate amount of control solution with acetonitrile-water (1:1) A solution containing about 0.5ug per 1 ml was prepared by quantitative dilution and used as a sensitive solution. The other standard reference substance of quinone-type rifampicin, reference substance of N-rifampicin oxide and reference substance of 3-formylrifamycin SV were accurately weighed, after the appropriate amount of acetonitrile (about 10 mg plus 1 ml of acetonitrile) was added and dissolved, the solution was quantitatively diluted with acetonitrile-water (1:1) to prepare about 10ug of each solution per 1 ml, as impurity control solutions (1), (2) and (3), respectively. According to the chromatographic conditions under the content determination item, 10ul of the sensitivity solution was injected into the liquid chromatograph, and the chromatogram was recorded. The signal-to-noise ratio of the peak height of the principal component chromatogram should be greater than 10, the impurity reference solution (1), (2), (3) and the test solution are 10 u1, respectively injected into the human liquid chromatograph, and the chromatogram is recorded to 4 times of the retention time of the main component peak. If there are impurity peaks in the chromatogram of the test solution, the peak areas of quinone-type rifampicin, N-rifampicin oxide and 3-formylrifamycin SV shall not exceed 1.5%, 0.5% and 0.5%, respectively, based on the external standard method; the Peak area of other individual impurities shall not be greater than the main peak area of the control solution (1.0% ), and the sum of the peak areas of other impurities shall not be greater than 3 times (3.0%) of the main peak area of the control solution.
loss on drying
take this product, dry to constant weight at 105°C, weight loss shall not exceed 1.0% (General rule 0831).
ignition residue
lg of this product shall be taken for inspection according to law (General rule 0841), and the remaining residue shall not exceed 0.1%.
Heavy metals
The residue left under the item of taking the ignition residue shall not contain more than 20 parts per million of heavy metal when examined by law (General rule 0821, Law II).
Last Update：2022-01-01 11:58:04
Dipicin - Content determination
Authoritative Data Verified Data
measured by high performance liquid chromatography (General 0512).
chromatographic conditions and system suitability test
with octylsilane bonded silica gel as filler; Methanol-acetonitrile -0.075mol/L potassium dihydrogen phosphate solution -1.Omol/L acid solution (30:30:36:4) as mobile phase; The detection wavelength was 254nm. Take the appropriate amount of rifampicin control, quinone-type rifampicin control, rifampicin oxide control and rifamycin SV control, add the appropriate amount of acetonitrile (about 10 mg plus lm l acetonitrile) dissolved, then use acetonitrile-water (1:1) dilute to prepare A mixed solution containing about 0.04mg each per 1 ml [impurity A generated in this solution by the quinone-type rifampicin and the N-oxide rifampicin (I. E., the adjacent impurity after the quinone-type rifampicin)], l01 is injected into human liquid chromatograph, and the separation degree between quinone-type rifampicin peak and impurity A peak, rifampicin peak and rifamycin SV peak shall meet the requirements.
assay
ready-to-use fresh or stored at 2 to 8°C for use within 6 hours. Take an appropriate amount of this product, precision weighing, add acetonitrile to dissolve and quantitatively dilute to make a solution containing about 0.1mg per lml; Take an appropriate amount of precision, use acetonitrile-water (1:1) the quantitative dilution is made to contain about 0.lmg solution, as the test solution, the precise amount of 10ul is injected into the liquid chromatograph, and the chromatogram is recorded; An appropriate amount of rifampicin reference substance is taken, and the precision is weighed and determined by the same method. According to the external standard method to calculate the peak area, that is.
Last Update：2022-01-01 11:58:05
Dipicin - Category
Authoritative Data Verified Data
anti-tuberculosis drugs.
Last Update：2022-01-01 11:58:05
Dipicin - Storage
Authoritative Data Verified Data
sealed and stored in a dry dark place.
Last Update：2022-01-01 11:58:05
Dipicin - Rifampicin tablets
Authoritative Data Verified Data
This product contains rifampicin (C43H58N4012) should be the label amount of 90.0% ~ 110.0%.
trait
This product is sugar-coated tablets. After removal of the coating, it appears orange-red or dark-red.
identification
- take an appropriate amount of fine powder of this product, add methanol to dissolve and dilute to make a solution containing about 10 mg of rifampicin per 1 ml, filter, and take the filtrate to test the identification (2) under the item of rifampicin, the same results are shown.
- 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.
- two items (1) and (2) above can be selected as one item.
examination
- precise weighing of related substances the appropriate amount of fine powder under the content determination item (approximately equivalent to rifampicin O. 1G), with a small amount of acetonitrile (about rifampicin 10 mg plus 1 ml acetonitrile) dissolved, and then acetonitrile-water (1:1) quantitative dilution to make each 1 mL solution containing about 1 mg of rifampicin, filter with 0.45um filter, take the filtrate as the test solution, according to the method under the rifampicin determination, quinone-type rifampicin, N-oxidation rifampicin, 3-formylrifamycin SV shall be calculated by peak area as external standard method and shall not exceed 3.0%, 1.0% and 0.5% of the labeled amount, the sum of the peak areas of other impurities shall not be greater than 3.5 times (3.5%) of the main peak area of the control solution.
- dissolution dissolution of this product, according to the dissolution and release determination method (General 0931 second method), hydrochloric acid solution (9-1000)900ml as the dissolution medium, the rotation speed is 50 rpm, operate in accordance with the law, 45 minutes, take the appropriate amount of solution, filtration, precision take the appropriate amount of filtrate, with phosphate buffer (take potassium dihydrogen phosphate 3.02g and dipotassium hydrogen phosphate 6.2g, add water to dissolve into l000ml,pH 7.0) make a solution containing about 20ug of rifampicin per 1 ml by quantitative dilution, and measure the absorbance at the wavelength of 474mn immediately by UV-visible spectrophotometry (General rule 0401), the elution amount of each tablet was calculated as an absorption coefficient of C43H58N4012 of 187. The limit is 70% 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
Take 10 tablets of this product, precision weighing, fine grinding, precision weighing appropriate amount (about equivalent to rifampicin lOOmg), plus a small amount of acetonitrile (rifampicin lOmg plus lml acetonitrile) dissolved, then quantitatively dilute with acetonitrile-water (1:1) to make a solution containing about 1 mg of rifampicin in each lml, filter with 0.45ug filter, take appropriate amount of filtrate with precision, and use acetonitrile-water (1:1) quantitative dilution is made to contain rifampicin about 0. A solution of 1 mg was obtained by measuring rifampicin as a test solution.
category
rifampicin.
specification
0.15g
storage
sealed and stored in a dark dry place.
Last Update：2022-01-01 11:58:06
Dipicin - Rlfamploin Campules
Authoritative Data Verified Data
This product contains rifampicin (C43H58N4012) should be the label amount of 90.0% ~ 110.0%.
identification
- take an appropriate amount of the contents of this product, add methanol to dissolve and dilute to make a solution containing about 10 mg of rifampicin per 1 ml, filter, take the filtrate, and identify according to the item of rifampicin (2) test, showing the same results.
- 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.
- two items (1) and (2) above can be selected as one item.
examination
- appropriate amount of content under the item of difference in the amount of related substances taken (approximately equivalent to rifampicin O.lg ), Precision weighing, add a small amount of acetonitrile (about rifampicin 10 mg plus lml acetonitrile) dissolved, then acetonitrile-water (1:1) the solution containing about 1 mg of rifampicin per 1 ml was prepared by quantitative dilution, filtered with 0.45um filter membrane, and the filtrate was taken as the test solution, which was determined according to the method under the item of rifampicin, rifampicin N-oxide, 3-formylrifamycin SV shall be calculated by peak area as external standard method and shall not exceed 2.0%, 1.0% and 0.5% of the labeled amount respectively, the sum of the peak areas of other impurities shall not be greater than 3.5 times (3.5%) of the main peak area of the control solution.
- weight loss on drying the contents of this product shall be taken and dried at 105°C to constant weight, and the weight loss shall not exceed 2.0% (General rule 0831).
- dissolution dissolution of this product, according to the dissolution and release determination method (General rule 0931 The first method), hydrochloric acid solution (9-1000)900ml as the dissolution medium, the rotation speed is 50 rpm, operate in accordance with the law, 45 minutes, take the appropriate amount of solution, filtration, precision take the appropriate amount of filtrate, with phosphate buffer (take potassium dihydrogen phosphate 3.02g and dipotassium hydrogen phosphate 6.2g, add water to dissolve into l000ml,pH 7.0) make a solution containing about 20ug of rifampicin per 1 ml by quantitative dilution, and measure the absorbance at the wavelength of 474nm immediately by UV-visible spectrophotometry (General rule 0401), the amount of dissolution per pellet was calculated as an absorption coefficient of C43H58N4012 of 187. 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
The contents under the item of difference in loading amount were collected and mixed uniformly. Precision weighing appropriate amount (about equivalent to rifampicin lOOmg), add a small amount of acetonitrile (about rifampicin lOOmg plus lml acetonitrile) dissolved, and then acetonitrile-water (1:1) quantitative dilution is made into a solution containing about 1 mg of rifampicin in each lml, filtered with 0.45um filter membrane, and the appropriate amount of filtrate is taken in a precise amount, and acetonitrile-water (1:1) is used. Quantitative dilution was made to contain rifampicin 0. A solution of 1 mg was obtained by measuring rifampicin as a test solution.
category
rifampicin.
specification
(1)0.15g (2)0.3g
storage
sealed and stored in a dark dry place.
Last Update：2022-01-01 11:58:07
Dipicin - Rifampicin for injection
Authoritative Data Verified Data
This product is a sterile preparation made by adding an appropriate amount of cosolvent. The content of rifampicin (C43H58N4012) shall be between 90.0% and 110.0% of the labeled amount.
trait
This product is dark red loose lumps and powder.
identification
- take an appropriate amount of this product, add methanol to dissolve and dilute to prepare a solution containing about 10 mg of rifampicin per 1 ml. According to the rifampicin identification (2) test, the same results were shown.
- 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.
- two items (1) and (2) above can be selected as one item.
examination
- alkalinity: take an appropriate amount of this product, add water to dissolve and dilute to prepare a solution containing about 60mg of rifampicin per 1 ml, and determine it according to law (General rule 0631). The pH value should be 7.8~8.8.
- clarity of solution take 5 bottles of this product and add water separately to make a solution containing about 0902 mg of rifampicin per 1 ml. The solution should be clarified (General rule method 1).
- the moisture content of this product shall not exceed 0832 as determined by the method for determination of moisture (General rule 1.5%, first method 1).
- appropriate amount of related substances, precision weighing, add a small amount of acetonitrile (about rifampicin 10 mg plus acetonitrile lml) dissolved, and then acetonitrile-water (1:1) the quantitative dilution is made into a solution containing about 1 mg of rifampicin per 1 ml, which is used as a test solution and determined according to the method under the item of rifampicin, rifampicin N-oxide, 3-formylrifamycin S V shall be calculated by peak area according to external standard method, and shall not exceed 1.5%, 1.0% and 1.0% of the labeled amount respectively; the sum of the peak areas of other impurities shall not be greater than 3.5 times (3.5%) of the main peak area of the control solution.
- the bacterial endotoxin of this product is taken and checked according to law (General rule 1143). The amount of endotoxin per 1 mg Rifampicin should be less than 0.50EU.
- sterile take this product, dissolve and dilute with appropriate solvent, after the membrane filtration method, inspection according to law (General rule 1101), should comply with the provisions.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
take the appropriate amount of content under the difference of loading, weigh it precisely, add a small amount of acetonitrile (about rifampicin 10 mg plus acetonitrile 1 ml) to dissolve, then use acetonitrile-water (1:1) the quantitative dilution was made to contain about 0.% rifampicin per 1 ml. A solution of 1 mg was obtained by measuring rifampicin as a test solution.
category
rifampicin.
specification
(1)0.15g (2 )0.45g (3)0.6g
storage
sealed and stored in a cool dark dry place.
Last Update：2022-01-01 11:58:08
Dipicin - Ethambutol Hydrochloride, Rifampincin and Isoniazid Tablets
Authoritative Data Verified Data
This product is a compound preparation containing rifampicin, isoniazid and ethambutol hydrochloride.
trait
This product is a film-coated tablet, and appears red after removing the coating.
identification
- take an appropriate amount of fine powder of this product (equivalent to rifampicin 5mg), add 0.1 mol/L hydrochloric acid solution 2ml, after shaking, add 0.1 mol/L sodium nitrite solution 2 drops, namely from orange to dark red.
- take an appropriate amount of fine powder of this product (about 0.lg of isoniazid), add 7ml of water, shake, filter, take the filtrate, add 0.1 mol/L silver nitrate solution 3ml, shake, filter, filtrate in the test tube, add ammonia silver nitrate solution 1ml, that is, the occurrence of bubbles and black turbidity, and the generation of silver mirror on the test tube.
- take an appropriate amount of fine powder of this product (about 20mg of ethambutol hydrochloride), add 10ml of water, shake, filter, take the filtrate, add 0.2g of sodium chloride, extract 3 times with chloroform, 20ml each time, take the upper water solution, add 2-3 drops of copper sulfate solution, and add several drops of sodium hydroxide solution. The solution is dark blue.
- in the chromatogram recorded under the content determination of rifampicin, 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 chromatograms recorded under the items of isoniazid and ethambutol hydrochloride for content determination, the retention times of the two main peaks of the test solution should be respectively consistent with the retention times of the corresponding two main peaks of the control solution.
examination
- new system of related substances in clinical use. Precision weighing the amount of fine powder under the content determination of rifampicin (about 50mg equivalent to rifampicin), add acetonitrile-water (1:1) dissolve and quantitatively dilute to make a solution containing about 0.5mg of rifampicin per 1ml, shake well, filter, and take the filtrate as the test solution; Take an appropriate amount of rifampicin reference substance, and weigh it precisely, add acetonitrile-water (1:1) to dissolve and quantitatively dilute to prepare a solution containing about 5ug per 1ml as a reference solution; Take additional quinone-type rifampicin, rifampicin N-oxide and 3-formylrifamycin SV were added respectively with acetonitrile-water (1:1). Dissolve and quantitatively dilute to prepare solutions containing about 5ug each in 1ml, respectively as impurity reference solutions (1), (2) and (3), according to the chromatographic conditions under the content determination of rifampicin, the sample solution, the reference solution and the impurity reference solution (1), (2) and (3) are accurately measured immediately, human liquid chromatograph was injected respectively, and the chromatogram was recorded to 5 times of the retention time of the main component peak. If there are impurity peaks in the chromatogram of the test solution, the peak areas of quinone-type rifampicin, N-rifampicin oxide and 3-formylrifamycin SV shall be calculated according to the external standard method and shall not exceed 2.0% of the labeled amount of rifampicin, 2.0% and 0.5%; Isoniazid rifamycin hydrazone shall not exceed 3.0% of the labeled amount of rifampicin, and other single impurities shall not exceed 1.5% of the labeled amount of rifampicin, calculated by the peak area of rifampicin in the solution of the reference substance according to the external standard method, the sum of each other impurity shall not exceed 3.0% of the labeled amount of rifampicin. The chromatographic peaks with impurity content less than 0.1% and relative retention time less than 0.23 are negligible.
- dissolution dissolution of this product, according to the dissolution and release determination method (General rule 0931 second method), with 0.01mol/L phosphate buffer solution (take anhydrous disodium hydrogen phosphate 7G, add water 5000ml to dissolve, adjust the pH value to 6.8 with phosphoric acid) 900ml as dissolution medium, with a rotation speed of 75 rpm, operate according to law. After 45 minutes, take appropriate amount of solution, filter, and use precise amount of meichuang liquid, A solution containing about 6ug of rifampicin per 1ml was prepared by quantitative dilution with dissolution medium as a test solution; An appropriate amount of rifampicin, isoniazid and ethambutol hydrochloride was additionally taken and accurately weighed, respectively, the dissolution medium is added to dissolve and quantitatively dilute into a solution with approximately the same concentration of each component in the test solution, which is respectively used as the mixed reference solution of rifampicin and isoniazid and ethambutol hydrochloride, the dissolution amounts of rifampicin, isoniazid and ethyl acetate and butyl acetate in each tablet were calculated respectively according to the determination method under the respective items of content determination. The limit of rifampicin is 75% of the labeled amount, and the R degrees of isoniazid and B- butene hydrochloride are both 80% of the labeled amount and shall comply with the regulations.
- loss on drying: take the fine powder of this product and dry it under vacuum at 60°C for 3 hours, and the weight loss shall not exceed 3.0% (General rule 0831).
- others shall be in accordance with the relevant provisions under the item of tablets (General rule 0101).
Content determination
Rifampicin was determined by high performance liquid chromatography (General 0521).
- chromatographic conditions and system suitability test using octyl silane bonded silica gel as filler; Methanol-acetonitrile -0.075mol/L potassium dihydrogen phosphate solution -1.0 mol/L hydrochloric acid solution (30:30:36:4), and adjust the pH value to 7.0 with 10 mol/L sodium hydroxide solution; The detection wavelength was 254nm. The product solution of isoniazid and rifampicin in acid (4mg of rifampicin control and 2mg of isoniazid control, dissolved by adding 1 mol/L acetic acid solution (25ml) for 4 hours) 20 u1, immediately inject human liquid chromatograph, record chromatogram, the peak sequence is isoniazid peak, isoniazid rifamycin hydrazone peak and rifampicin peak. The separation degree between isoniazid rifamycin hydrazone peak and rifampicin peak should be greater than 4.0, and the separation degree between rifampicin peak and adjacent impurity peak should meet the requirements.
- A new assay was used. Take 20 tablets of this product, precision weighing, fine grinding, precision weighing fine powder appropriate amount (equivalent to rifampicin 60mg), add acetonitrile-water (1:1) the solution was shaken to dissolve rifampicin and quantitatively diluted to prepare a solution containing about 60ug of rifampicin per 1ml. The solution was shaken well, filtered, and the continued filtrate was taken as the test solution, immediately, accurately measure 20u1 and inject human liquid chromatograph, record chromatogram; Accurately weigh appropriate amount of rifampicin reference substance, and add acetonitrile-water (1:1). The solution was shaken to dissolve and quantitatively diluted to prepare a solution containing about 60ug per 1ml, which was determined by the same method. According to the external standard method to calculate the peak area, that is.
isoniazid and ethambutol hydrochloride were determined by high performance liquid chromatography (General 0512).
- chromatographic conditions and system applicability test using eighteen alkyl silane bonded silica gel as filler; With copper acetate-ammonium acetate solution (50g of ammonium acetate and copper acetate 0.2g, add water 1000ml to dissolve, the pH value was adjusted to 5.0 with glacial acetic acid)-methanol (94:6) as mobile phase; The detection wavelength was 270mn. 20M1 of the mixed reference solution was injected into the human liquid chromatograph, and the chromatogram was recorded. The peak sequence was isoniazid peak and ethambutol hydrochloride peak, and the separation degree between isoniazid peak and ethambutol peak should meet the requirements.
- determination method an appropriate amount of fine powder (about equivalent to 30mg of isoniazid) under the item of content determination of rifampicin, precision weighing, adding an appropriate amount of water, ultrasonic dissolution of isoniazid and ethambutol hydrochloride and quantitative dilution to make a solution containing about 30ug of isoniazid per lml, filtration, take the continued filtrate as the test solution, immediately take 20 u1, note human liquid chromatograph, record chromatogram; Take appropriate amount of isoniazid reference substance and ethambutol hydrochloride reference substance separately, weigh precisely, add water to dissolve and quantitatively dilute to make the solution with the same concentration of each component as the test solution, as a mixed control solution, the same method was used. The contents of isoniazid (C5H7N30) and ethambutol hydrochloride (C43H58N4012 · 2HC1) were calculated by peak area according to external standard method.
category
anti-tuberculosis drugs.
storage
light-shielded, sealed, and stored in a dry place.
Last Update：2022-01-01 11:29:03
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CAS: 13292-46-1
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Email: sales@tnjchem.com
info@tnjchem.com
Mobile: 0086 189 4982 3763
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Wechat: 0086 189 4982 3763
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Product List: View Catalog
Multiple SpecificationsSpot supply
Product Name: Rifampicin Visit Supplier Webpage Request for quotationCAS: 13292-46-1
Tel: 18301782025
Email: 3008007409@qq.com
Mobile: 18021002903
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View History
Raw Materials for Dipicin