Azithromycin

CHARACTERISTICSWHITE CRYSTALLINE POWDERCONFORMSIDENTIFICATION1. IR TESTCONFORMSB. HPLCCONFORMSSPECIFIC ROTATION-45 -49°- 47.5°CRYSTALLINITYCONFORMSCONFORMSPH9.0 11.010.1WATER4.0 5.0%4.50%RESIDUE ON IGNITION≤0.3%0.03%HEAVY METALS≤25PPM< 20PPMASSAY (HPLC DRIED SUBSTANCE)945μg/mg 1030μg/mg977.8μg/mgRELATIVE SUBSTANCE≤1.0%CONFORMS 1.DESOSAMINYLAZITHROMYCIN≤0.3%0.09% N-DEMETHYLAZITHROMYCIN≤0.7%0.40% 2. ANY OTHER IMPURITY0.28% 3. TOTAL IMPURITY≤3.0%1.30%RESIDUE SOLVENT 1. METHYLENE CHLORIDE≤0.06%<0.06% 2. ACETONE≤0.5%<0.5%