provide Azithromycin
Certificate of Analysis
Product Name:Azithromycin dihydrate Specification:25/kgdrum
Batch No.:A20100516 Batch Quantity:475kg
Manu.Date:2010.05.21 Report Date:2010.05.30
Restest Date:2014.05.20 Testing Basis:USP26
TEST SPECIFICATION RESULT
Characters White crystallinity powder Complies
Identification a)Infrared Absorption
b)HPLC Complies
Specific rotation -45°— -49° -47°
Crystallinity Meets the requirements Complies
PH 9.0—11.0 10.3
Water 4.0%—5.0% 4.3%
Residueonignition ≤0.3% 0.08%
Heavy metals ≤0.0025% <0.0025%
Assay 945u/mg—1030u/mg 952ug/mg
Calculated on the anhydrous basis
Conclusion:The above product contorms to USP26.
Azithromycin dihydrate USP26/USP32