Clarithromycin USP Sulfonic Acid Derivatives Test Specification Min Max ASSAY

Test Specification Min Max ASSAY (by TITRATION) 98%

589 nm DYE CONTENT 50%

0 % COLOR (APHA) 10 CHLORIDE (Cl) 80 ppb PHOSPHATE (PO[@4@]) 200 ppb SULFATES (SO[@4@]) 500 ppb ARSENIC 5 ppb ANTIMONY (Sb) 5 ppb ALUMINUM 200 ppb BORON (B) 100 ppb CALCIUM (Ca) 200 ppb CHROMIUM (Cr) 100 ppb COPPER (Cu) 50 ppb GOLD (Au) 300 ppb IRON (Fe) 200 ppb LEAD (Pb) 100 ppb MAGNESIUM (Mg) 300 ppb MANGANESE (Mn) 200 ppb NICKEL (Ni) 50 ppb POTASSIUM (K) 300 ppb SODIUM (Na) 300 ppb TIN (Sn) 300 ppb TITANIUM (Ti) 300 ppb ZINC (Zn) 300 ppb PARTICLE COUNT (>/=1

30% RESIDUE ON IGNITION 0

Test Specification Min Max ASSAY (OsO[@4@]) 98

Clarithromycin USP Sulfonic Acid Derivatives Test Specification Min Max ASSAYTest Specification Min Max ASSAY (ANHYDROUS BASIS) 96 102. 00% SPECIFIC ROTATION (20C) 94 to 102 94 to 102 CRYSTALLINITY TO PASS TEST TO PASS TEST pH 8 10 WATER DETERMINATION 2. 00% RESIDUE ON IGNITION 0. 20% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED ORGANIC IMPURITIES TO PASS TEST TO PASS TEST IDENTIFICATION TO PASS TEST TO PASS TEST EXPIRATION DATE DATE OF MANUFACTURE APPEARANCE RESIDUAL SOLVENTS: TO PASS TEST TO PASS TEST CLASS 2 (SOLVENT)