|Appearance||It occurs as white or almost white, crystalline powder or colorless crystals.|
|Identification Test A Test B Test C||a. Melting point – Between 125 °C to 128 °C b. Infrared absorption spectrophotometry c. Thin - layer chromatography|
|Solubility||Very slightly soluble in water, freely soluble in ethanol (96 %) and in methanol.|
|Appearance of solution||Solution is clear and not more intensely colored than reference solution BY6|
|Related substances a. Correction factor b. Impurity A c. Unspecified impurity d. Total||Specified test Not more than 0.5% Not more than 0.5% Not more than 1.0%|
|Sulfated ash||Not more than 0.1%|
|Assay||Not less than 98.0% and not more than 102.0%.|
Shelf life, Storage and Packing
It should be stored in a segregated area in a cool and ventilated place away from combustible materials. Keep in a tightly closed container, sealed until ready for use. It is packed in 25kg or 50kg HDPE bags or drums as required.
GLP, cGMP (FDA) Approved, WHO-GMP, ISO 9001: 2015, ISO14001:2015, OHSAS18001:2007, FSSC 22000: 2005, FSSAI, Kosher and Halal Certified.