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. Roxar, Roximycin, Roxomycin, Tirabicin and Coroxin.
CERTIFICATE OF ANALYSIS of Roxithromycin
| 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.
Roxithromycin is one of the most commonly used broad-spectrum and highly effective anti-inflammatory drugs, and is a member of the broad-spectrum antimicrobial family. General name roxithromycin capsules, roxithromycin enteric-coated tablets, roxithromycin dispersing tablets, roxithromycin dry suspension, etc. Often used for streptococcus pyogenes caused by pharyngitis and tonsillitis, sensitive bacteria caused by all kinds of inflammation.
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