|Characters||It occurs as white or almost white, crystalline powder or colorless, transparent crystals.|
|Identification- Test A Test B Test C Test D||
|Solubility||Very soluble in water, practically insoluble in ethanol (96%)|
|Appearance of solution||Solution is clear and colorless|
|Acidity and alkalinity||To 5 mL of solution S, add 0.1 mL of phenolphthalein solution R. Not more than 0.5 mL of 0.01 M hydrochloric acid or 0.01 M sodium hydroxide is required to change the colour of the indicator.|
|Specific optical rotation||+ 28.0 to + 30.0 (anhydrous substance)|
|Chloride||Not more than 100 ppm|
|Sulfates||Not more than 50 ppm|
|Ammonium||Not more than 40 ppm|
|Barium and oxalates||Specified test.|
|Calcium||Not more than 200 ppm|
|Water||24.0% to 26.5%|
|Assay||Not less than 98.0% and 101.0% (anhydrous substance)|
|Characters||It occurs as colorless crystals or white crystalline powder|
|Identification Test (A) Test (B) Test(C)||(a) Specified test. (b) Specified test. A white, crystalline precipitate is formed within 15 minutes (c) It gives reaction of tartrate|
|Solubility||Freely soluble in water, practically insoluble in alcohol.|
|Limit of ammonia||Not more than 0.002%|
|Heavy metals||Not more than 0.001%|
|Residual solvents||Meets the requirements|
|Assay||Not less than 99.0% and not more than 102.0% calculated on the 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.