Molecular Formula | C18H34Cl2N2O5S |
Molar Mass | 461.44 |
Melting Point | 141°C |
Boling Point | 647°C at 760 mmHg |
Flash Point | 345.1°C |
Solubility | H2O: 50mg/mL, clear, colorless |
Vapor Presure | 1.79E-19mmHg at 25°C |
Appearance | White crystalline powder |
Color | White to Off-White |
BRN | 4070786 |
Storage Condition | 2-8°C |
Stability | Hygroscopic |
MDL | MFCD07793327 |
Physical and Chemical Properties | Melting Point: 141°C |
Use | Lincomycin derivatives, Staphylococcus aureus, Pneumonia cocci bactericidal activity many times stronger than lincomycin |
Hazard Symbols | Xi - Irritant |
Risk Codes | 36/37/38 - Irritating to eyes, respiratory system 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 | 2 |
RTECS | GF2275000 |
FLUKA BRAND F CODES | 10 |
HS Code | 29419000 |
Raw Materials | Lincocin Hydrochloride Ethyl Alcohol |
Reference Show more | 1. Wang Meng, Bi Qianyu, Shang Linlin, et al. Study on Bacteriostasis and Skin Irritation in Compound Clindamycin Liposome [J]. Northwest Journal of Pharmacy, 2019, 034(006):775-778. 2. Wang Meng, Shang Linlin, Lu Chuanfeng, et al. Preparation of Compound Clindamycin Liposome Gel and Study on Transdermal Release in Vitro [J]. Northwest Journal of Pharmacy, 2019, 034(004):530-533. 3. Nie Hemin, Zhang Zongyao, Huang Yumei, et al. Drug Resistance Investigation and PFGE Typing of Campylobacter Chickens in Guangdong Province [J]. Chinese Veterinary Science, 2018, 048(010):1265-1271. 4. [IF = 4.36] Qingsong Qu et al."Effects of fermented ginseng on the gut microbiota and immunity of rats with antibiotic-associated diarrhea." J Ethnopharmacol. 2021 Mar;267:113594 |
This product is 7-chloro-6, 7, 8-dideoxy-6- (l-methyl-trans-4-propyl-L-2-pyrrolidinylamino) 1-thio-L-threonine-a-D-pyrrogalactopyranoside IV hydrochloride. Clindamycin (C18H33C1N205S) shall not be less than 83.0% calculated as anhydrous.
take this product, precision weighing, water dissolution and quantitative dilution of about 40mg per lml solution, according to the law (General 0621), specific rotation of 135 ° to 150 °.
take this product, according to the law inspection (General 0981), should comply with the provisions.
take this product, add water to make a solution containing O.lg per lml, check according to law (General 0631) ,pH value should be 3.0~5.5.
take an appropriate amount of this product, add the mobile phase to dissolve and dilute to make 4.0 mg of the solution was used as the test solution; An appropriate amount was taken in a precise amount and quantitatively diluted with the mobile phase to prepare a solution containing about 80ug per 1 ml as a control solution. According to the chromatographic conditions under the content determination item, 20 u1 of each of the test solution and the control solution are accurately measured and injected into the human liquid chromatograph respectively, and the chromatogram is recorded to 2 times of the retention time of the main component peak. If there are impurity peaks in the chromatogram of the test solution, the peak area of lincomycin (relative retention time is about 0.4) shall not be greater than 0.5 times (1.0%) of the main peak area of the control solution, clindamycin B (relative retention time is about 0.65) Peak area should not be greater than the control solution Main Peak area (2.0%),7-to clindamycin (relative retention time is about 0.8) the peak area shall not be greater than 0.75 times (1.5%) of the main peak area of the control solution, and the peak area of other individual impurities shall not be greater than 0.25 times (0.5%) of the main peak area of the control solution, the sum of each impurity peak area shall not be greater than 3 times (6.0%) of the main peak area of the control solution.
take this product, according to the moisture determination method (General 0832 first method 1), the water content shall not exceed 6.0%.
not more than 0.5% (General rule 0841).
measured by high performance liquid chromatography (General 0512).
silica gel bonded with eighteen alkyl silane as filler; Potassium dihydrogen phosphate solution (6.8mg of potassium dihydrogen phosphate per 1 ml, adjusted to pH 25% with 7.5 potassium hydroxide solution)-acetonitrile (55:45) as the mobile phase; The detection wavelength is 210mn; Take an appropriate amount of clindamycin control, add the mobile phase to dissolve and dilute to make 4 per 1 ml. 0 mg of the solution, 20 U1 was injected into the liquid chromatograph, and the chromatogram was recorded; The retention time of the main peak of clindamycin was about 10 minutes. Clindamycin B Peak (relative retention time about 0.65) and 7-episodic clindamycin peak (relative retention time about 0.8) and the 7-episodic clindamycin peak should be separated from the clindamycin peak by greater than 3.0.
take about 50mg of this product, weigh it accurately, put it in a 50ml measuring flask, add the mobile phase to dissolve and dilute to the scale, shake it well, and use it as a test solution, the chromatogram was recorded by injection of 20u1 into human liquid chromatograph, and an appropriate amount of clindamycin reference substance was taken for determination by the same method. The content of c18h33c1n205 S was calculated by peak area according to external standard method.
antibiotics.
sealed storage.
This product contains clindamycin hydrochloride according to clindamycin (C18H33CIN205S) calculation, should be 90.0% ~ 110.0% of the label amount.
The content of this product is white powder or crystalline powder or granules.
take the contents under the difference of loading amount, mix evenly, weigh an appropriate amount (about equivalent to clindamycin 0.lg) accurately, put it in a 100ml measuring flask, add the mobile phase to dissolve and dilute to the scale, shake, filter, take the filtrate as a test solution, according to the method under the item of clindamycin hydrochloride, obtained.
with clindamycin hydrochloride.
Based on C18H33C1N205S (l)0.075g (2)0.lg(3)0.15g
sealed storage.