| Customization: | Available |
|---|---|
| Powder: | Yes |
| Customized: | Non-Customized |
|
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| BATCH NO.: TGY231202 | QUANTITY:75.1kg | ||
| MFG. DATE : Dec., 2, 2023 | SPECIFICATION: As required | ||
| REP. DATE : Dec.4, 2023 | EXP. DATE : Dec., 2025 | ||
| ITEMS |
STANDARDS |
RESULTS |
|
Appearance |
White or off-white crystalline powder | Off-white crystalline powder | |
| Identification | By IR | Complies | |
| RT under chirality should complies | Complies | ||
| Chloride: it gives a reaction of chloride | Complies | ||
| Water | 3.0%~4.5% | 3.4% | |
Melting Point |
198.0~202.0ºC | 199.8~200.5ºC | |
| Residue on Ignition | ≤0.2% | 0.08% | |
| Heavy Metals | ≤10ppm | Complies | |
| Related Substances | Individual Impurities:≤0.5% | 0.15% | |
| Total Impurities:≤1.0% | 0.22% | ||
| Residual Solvent | Dichlorometha ≤0.06% | 0.0066% | |
| Aceton ≤0.5% | 0.015% | ||
| Ethyl aceta ≤0.5% | 0.0013% | ||
| E.E | ≥99.0% | 99.6% | |
Assay (on dry basis) |
98.0%~102.0% | 101.2% | |
| Conclusion:It complies to prescribed enterprise standard. | |||
Roxithromycin is a semi-synthetic macrolide antibiotic. It is used to treat respiratory tract, urinary and soft tissue infections. Roxithromycin is derived from erythromycin, containing the same 14-membered lactone ring. However, an N-oxime side chain is attached to the lactone ring. It is also currently undergoing clinical trials for the treatment of male-pattern hair loss.
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