|Characters||It appears as white or yellowish, crystalline powder or crystals.|
|Identification Test (A) Test (B) Test(C) Test (D)||a. Specific optical rotation- Between +103° and +108° b. Infrared Absorption Sprectrophotometry c. Specified test. A grey precipitate is formed. d. It gives reaction of sodium|
|Solubility||Freely soluble in water, sparingly soluble in ethanol (96 %), practically insoluble in methylene chloride.|
|Appearance of solution||Solution S is clear and not more intensely colored than reference solution Y6 or BY6 examine the color immediately after preparation of the solution.|
|Specific optical rotation||Between +103° and +108°(dried substance)|
|pH||Between 7.0 to 8.0|
|Impurity E||Not more than 0.3 %|
|Related substances- 1. Impurities C, D 2. Unspecified impurities 3. Total of impurities other than C and D||1. Not more than 0.15 % 2. Not more than 0.10% 3. Not more than 0.2 %|
|Sulfates||Not more than 150 ppm|
|Copper||Not more than 5 ppm|
|Iron||Not more than 2 ppm|
|Nickel||Not more than 1 ppm|
|Loss on drying||Not more than 0.25%|
|Assay||Not less than 99.0% to not more than 101.0% (dried substance)|
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.