| Customization: | Available |
|---|---|
| Powder: | Yes |
| Customized: | Customized |
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| Item name | Clarithromycin |
| Synonyms | 6-O-Methylerythromycin |
| Molecular Formula | C38H69NO13 |
| Molecular weight | 747.96 |
| CAS No. | 81103-11-9 |
| Melting point | 217-220ºC |
| Appearance | white |
Clarithromycin, sold under the brand name Biaxin, is an antibiotic used to treat various bacterial infections.This includes strep throat, pneumonia, skin infections, H. pylori infection, and Lyme disease, among others. Clarithromycin can be taken by mouth as a pill or liquid.
Common side effects include nausea, vomiting, headaches, and diarrhea. Severe allergic reactions are rare. Liver problems have been reported. It may cause harm if taken during pregnancy. It is in the macrolide class and works by decreasing protein production of some bacteria.
| Items | Specifications | Results | |
| Appearance | White to almost white crystalline powder | white crystalline powder | |
| Identification | IR:conforms to the spectrum of clarithromycin RS | Conforms | |
| Specific optical rotation | -94.--102.(anhydrous substance,1 0mg/ml methylene chloride) |
-98. | |
| Sulphated ash | ≤ 0.2% | <0.01% | |
| Appearance of solution | Clear or not more opalescent than reference suspension II and not more intensely coloured than reference solutionY7 |
Conforms | |
| Crystallinity | Meet the requirements | Conforms | |
| pH | 8.0-10.0 | 8.7 | |
| Water | ≤ 2.0% | 0.35% | |
| Related substances | (1)any single impurity | ≤ 1.0% | 0.65% |
| (2)any impurities greater than 0.4% |
not more than 4 impurities | 1 | |
| (3)total impurities | ≤ 3.5% | 2.0% | |
| Heavy metals | ≤ 0.002% | 2.0% | |
| Residul solvents | Ethanol ≤ 5000ppm |
Not detected |
|
| Assay (on dried basis ) | 96.0% ~ 102.0%(anhydrous substance) | 97.3% | |
| Conclusion | It complies with USP38 standard. | ||
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