|Characters||It occurs as white crystalline powder|
Infrared absorption spectrophotometry.
Specific Optical rotation
Thin Layer Chromatography
|Solubility||Very soluble in water, slightly soluble in ethanol (96 %), practically insoluble in methylene chloride|
|Appearance of solution||Solution is clear and not more intensely colored than reference solution BY7|
|Acidity or alkalinity||Specified test.|
|Specific Optical rotation||+13.5° to +15.5°|
|Related Substances||Not more than 1.0%|
|Unspecified impurities||Not more than 0.1%|
|Other related Substances||Not more than 1.0%|
|Reducing Sugars||Not more than 0.2%|
|Lead||Not more than 0.5 ppm|
|Nickel||Not more than 1 ppm|
|Water||Between 4.5% to 5.5%|
|Sulphated Ash||Not more than 0.1 %|
|Assay||Not less than 96.5% and not more than 102.0% (anhydrous Substance)|
|Descriptions||It occurs a white or light brown, odorless crystal.|
(a) Infrared Absorption
|Residue of Ignition||Not more than 0.5 %|
|Heavy Metals||Not more than 5 ppm|
|Related Compounds||Not more than 1.5 %|
|Reducing sugars||Not more than 0.2 %|
|Water Determinination||Between 4.5 % – 5.5 %|
|Residual solvents||Meets the requirements|
|Assay||Not less than 98.0 % and not more than 101.0 % on anhydrous basis.|
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, ISO 9001, ISO 14001, ISO 45001, ISO 17025, ISO 22000, FSSC 22000, FSSAI, Halal and Kosher certified.
We observe WHO Good manufacturing practice and Good laboratory practice.