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 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.