Clarithromycin

CAS number:81103-11-9

Molecular formula:C38H69NO13

molecular weight:747.9534

Chemical structure:

PRODUCT NAME CLARITHROMYCIN
Shelf Life
4 years
ITEMS SPECIFICATIONS RESULTS
APPEARANCE WHITE TO ALMOST WHITE,CRYSTALLINE POWDER COMPLIES
SPECIFIC ROTATION -94° TO -102°(20℃) -96.9°
IDENTIFICATION IR SPECTRUM CORRESPONDS TO COMPLIES
CRYSTALLINITY MEETS THE REQUIREMENTS COMPLIES
PH 8.0-10.0 8.4
WATER NOT MORE THAN 2.0% 0.3%
RESIDUE ON IGNITION NOT MORE THAN 0.2% 0.02%
HEAVY METALS NOT MORE THAN 20UG/G COMPLIES
PARTICLE SIZE 40MESHES COMPLIES
RESIDUAL SOLVENTS ETHANOL NOT MORE THAN 5000PPM 300PPM
PYRIDINE HYDROCHLORIDE SHOULD NOT DETECTED ND
RELATED SUBSTANCES IMPURITY I NOT MORE THAN 1.0%
ND
IMPURITY A NOT MORE THAN 1.0%
ND
IMPURITY J NOT MORE THAN 1.0% ND
IMPURITY L NOT MORE THAN 1.0% ND
IMPURITY B NOT MORE THAN 1.0% ND
IMPURITY M NOT MORE THAN 1.0% 0.06%
IMPURITY C NOT MORE THAN 1.0% ND
IMPURITY D NOT MORE THAN 1.0% ND
IMPURITY N NOT MORE THAN 1.0% ND
RELATED COMPOUND A NOT MORE THAN 1.0%
ND
IMPURITY F NOT MORE THAN 1.0% 0.27%
IMPURITY P NOT MORE THAN 1.0% ND
IMPURITY O NOT MORE THAN 1.0% ND
IMPURITY K NOT MORE THAN 1.0% ND
IMPURITY G NOT MORE THAN 1.0% ND
IMPURITY H NOT MORE THAN 1.0% ND
Any individual impurity not more than 1.0% 0.6%
Impurity exceed 0.4% not more than 4
2
Total impurities not more than 3.5%
2.8%
ASSAY 96.0---102.0% ON ANHYDROUS BASIS 97.7%
CONCLUSION THIS BATCH OF PRODUCT IS IN CONFORMANCE WITH USP38