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S.No Test Specification
1. Description An off-white to pale grey colour crystalline powder, hygroscopic
2. Solublity Soluble in methanol and water. Insoluble in ethyl acetate.
3. Identification by IR IR chromatograph of sample should be similar to In-house standard
4. Loss on drying Not more than 1.0%
5. Purity by HPLC  
a. Individual impurity Not more than 0.5%
b. Total impurities Not more than 1.0%
6. Assay by Chemical Not less than 98.0%