Solubility: Slightly soluble in 0.1 N sodium hydroxide, in 0.1 N hydrochloride acid and in methanol. Very slightly soluble in acetone and in chloroform. Practically insoluble in water and in ether.
Identification By IR: IR absorption of the sample must be concordant with the standard spectrum.
Identification By HPLC: The retention time of the major peak of the sample corresponds to that of the standard solution, as obtained in the assay.
Water Content: Not more than 1.0 % w/w
Sulphated Ash: Not more than 0.1 % w/w
Heavy metals: Not more than 10 ppm
Impurity A by HPLC: Not more than 0.5% w/w
Any Unknown Impurity by HPLC: Not more than 0.5% w/w
Total impurities by HPLC: Not more than 1.0% w/w
Assay by HPLC: Not less than 98.0 % w/w and Not more than 102.0 % w/w.
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