Pharmaceutical Raw Materials

Azithromycin

CAS: 83905-01-5
Standard USP
Appearance white powder
Package:25kg/drum
Product description: used for a variety of infections caused by susceptible bacteria
INQUIRY

Azithromycin

Product Name: Azithromycin

CAS NO: 83905-01-5

Application:

For any antibiotic, used for a variety of infections caused by susceptible bacteria, such as respiratory infections, skin and soft tissue infections.

Sample: With Free

Specification:

Item	Spec.	Result
Characteristics	White or almost white powder	White powder
Identification
A:Infrared Absorption spectrum	Meets the requirement	Meets the requirement
B:The retention time	Corresponds to standard preparation	Meets the requirement
Tests
pH	9.0~11.0	10.2
Specific rotation	-45°~ -49°	-48°
Crystallinity	Meets the requirement	Meets the requirement
Related substance	Desosaminylazithromycin≤0.3%	0.01%
	N-demethylzaithromycin≤0.7%	0.1%
	Any other impurity≤1.0%	0.58%
	Total impurities≤3.0%	1.2%
Residue on ignition	≤0.3%	0.02%
Water	4.0%~5.0%	4.5%
Heavy metals	≤0.0025%	<0.0025%
Residual solvents(by GC)	Acetone Not more than 5000 ppm	573 ppm
Residual solvents(by GC)	Alcohol Not more than 5000 ppm	13 ppm
Assay	945μg/mg~1030μg/mg	997 μg/mg
Conclusion	The above product conforms to USP34
Remark	In house order number:90%<50 μm