Test | Specification...BP |
Characters | It occurs as a white or almost white, crystalline powder. |
Identification Test (A) Test (B) Test (C) | Specified test. The pH of dilution is less than 2. Specified test. Specified Test. A violet-pink color develops. |
Solubility | Freely soluble in water and in alcohol |
Appearance of solution | The solution is clear and not more intensely colored than the reference solution Y7 |
Fumaric acid | Specified Test. Thin layer chromatography. |
Iron | Not more than 5 ppm |
Water | Not more than 2.0% |
Sulfated ash | Not more than 0.1% |
Assay | Not less than 99.0% and not more than 101.0% calculated with reference to the anhydrous substance. |
Test | Specification...USP |
Characters | It occurs as a white crystalline powder |
Identification Test(A) Test(B) Test(C) | (a) Specified Test. The pH of the solution is less than 2 (b) Specified Test (c) Infrared Absorption |
Solubility | Freely soluble in water and in alcohol, sparingly soluble in ether |
Appearance of solution | The solution is clear and not more intensely colored than the reference solution |
Color and clarity of the solution | The sample solution is clear and not more intensely colored than the reference solution |
Water | Not more than 2.0% |
Residue on ignition | Not more than 0.1% |
Heavy metals | Not more than 10 ppm |
Fumaric acid | Not more than 1.5% |
Iron | Not more than 5 ppm |
Residual Solvents | Meets the requirements |
Assay | Not less than 99.0% and not more than 101.0% calculated 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.
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.