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l2
S.No Test Specification
1 Description A white to off-white colour crystalline powder
2 Solubility Soluble in Methanol, Ethyl acetate. Slightly soluble Methylene dichloride. Insoluble in Water
3 Identification by IR IR chromatograph of sample should be similar to In-house standard
4 Melting range 118°C – 122ºC
5 Loss on drying Not more than 1.0%
6 Sulphated ash Not more than 0.2%
7 Related Impurities by HPLC
a. Individual impurity Not more than 0.5%
b. Total impurity Not more than 1.0%
8 Purity by HPLC Not less than 99.0%