Clarithromycin USP34 CAS NO.81103-11-9

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Appearance A white or almost white crystalline powder

Solubility Practically insoluble in water,freely soluble in methylene chloride,soluble in acetone, slightly soluble in methanol,dehydrated alcohol and in acetonitrile.Slightly soluble in phosphate buffer at PH values of 2-5.

Identification IR Conforms to Clarithromycin RS

Crystallinity Meets the requirements

Specific optical rotation -94°~-102°

PH 8.0-10.0

Water 2.0% max

Sulphated ash 0.2% max

Heavy metals 20ppm max

Related substances I,A,J,L,B,M,C,D,N,E,F,P,O,K,G,H:1.0%Max

Any other impurity:0.1% max

More than 0.4% impurity: 4 max

Total impurities:3.5% max

Assay(on dry base) 96.0%~102.0%

Residual solvents Ethanol 3000ppm max

Bulk density 0.30g/ml~0.55g/ml

Tapped density 0.55g/ml~0.80g/ml

Particle size  90%min passes through 40mesh