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l2
S.NoTestSpecification
1DescriptionA white to off-white colour crystalline powder
2SolubilitySoluble in Methanol, Ethyl acetate. Slightly soluble Methylene dichloride. Insoluble in Water
3Identification by IRIR chromatograph of sample should be similar to In-house standard
4Melting range118°C – 122ºC
5Loss on dryingNot more than 1.0%
6Sulphated ashNot more than 0.2%
7Related Impurities by HPLC
a. Individual impurityNot more than 0.5%
b. Total impurityNot more than 1.0%
8Purity by HPLCNot less than 99.0%