Clarithromycin Ip/usp

Clarithromycin, specified under Indian Pharmacopoeia (IP) and United States Pharmacopeia (USP), has the following specifications:

Product Name: Clarithromycin
Chemical Name: 6-O-methylerythromycin
Appearance: White to off-white crystalline powder
Identification: Should comply with the relevant IP/USP test
Assay: Should contain not less than 97.0% and not more than 102.0% of clarithromycin (calculated on the dried basis)
Loss on Drying: Not more than 5.0%
Residue on Ignition: Not more than 0.2%
Heavy Metals: Not more than 20 ppm
Related Substances: Should comply with the relevant IP/USP test
Microbial Limits: Should comply with the relevant IP/USP test
Particle Size: Should comply with the relevant IP/USP test
Solubility: Freely soluble in methanol, slightly soluble in ethanol
Storage: Store in a tightly closed container, protected from light, at a temperature not exceeding 25C