 
 
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 | E
XP. 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 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.
