Test | Specification...BP |
Character | It occurs as a white or almost white, powder or crystalline powder, or colorless crystals. |
Identification
Test(A) Test(B) Test(C) |
(a) Specificoptical rotation (b) Examine the chromatograms obtained in the test for ninhydrin-positive substances. (c) It gives reaction of potassium |
Solubility | Very soluble in water, practically insoluble in alcohol and in methylene chloride. |
pH | Between 6.0 to 7.5 |
Appearance of solution | Solution is clear and colorless. |
Specific optical rotation | Between + 18.0 to + 20.5 (anhydrous substance) |
Ninhydrin- positive substances:
Test solution A Test solution B |
(a) Any spot, apart from the principal spot, is not more intense than the spot in the chromatogram obtained with reference solution. (b) Not more than 0.5% |
Chlorides | Not more than 200ppm |
Sulfates | Not more than 500ppm |
Ammonium | Not more than 200ppm |
Iron | Not more than 30ppm |
Heavy Metals | Not more than 10ppm |
Water | Between 4.0% to 6.0% |
Assay | Not less than 99.0% and not more than 101.0% (anhydrous substances) |
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.
Other
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.