Clarithromycin

CAS number: 81103-11-9

Molecular formula: C38H69NO13

molecular weight: 747.9534

Chemical structure:

PRODUCT NAMECLARITHROMYCIN
Shelf Life
4 years
ITEMSSPECIFICATIONSRESULTS
APPEARANCEWHITE TO ALMOST WHITE,CRYSTALLINE POWDERCOMPLIES
SPECIFIC ROTATION-94° TO -102°(20)-96.9°
IDENTIFICATIONIR SPECTRUM CORRESPONDS TOCOMPLIES
CRYSTALLINITYMEETS THE REQUIREMENTSCOMPLIES
PH8.0-10.08.4
WATERNOT MORE THAN 2.0%0.3%
RESIDUE ON IGNITIONNOT MORE THAN 0.2%0.02%
HEAVY METALSNOT MORE THAN 20UG/GCOMPLIES
PARTICLE SIZE40MESHESCOMPLIES
RESIDUAL SOLVENTSETHANOL NOT MORE THAN 5000PPM300PPM
PYRIDINE HYDROCHLORIDE SHOULD NOT DETECTEDND
RELATED SUBSTANCESIMPURITY 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%
ASSAY96.0---102.0% ON ANHYDROUS BASIS97.7%
CONCLUSIONTHIS BATCH OF PRODUCT IS IN CONFORMANCE WITH USP38