Test | Specification...BP |
Characters | It occurs as a white or almost white crystalline powder |
Identification Test A Test B | Melting point: 128oC to 132oC Infrared absorption spectrophotometry. |
Solubility | Freely soluble in water and in alcohol, sparingly soluble in acetone. |
Appearance of solution | Solution S is clear and colorless. |
Optical rotation | -0.10o to +0.10o |
Water insoluble substances | Not more than 0.1% |
Water | Not more than 2.0% |
Related Substance Impurity A Impurity B Any Other impurity Total of Other Impurity | Not more than 1.0% Not more than 0.05% Not more than 0.1% Not more than 0.5% |
Sulfated Ash | Not more than 0.1% |
Assay | Not less than 99.0% not more than 101.0% (anhydrous substances) |
Test | Specification...USP |
Characters | It occurs as a White or practically white, crystalline powder or granules, having a strongly acid taste |
Identification Test A | Infrared absorption |
Solubility | Very soluble in water; freely soluble in alcohol |
Appearance of solution | Solution S is clear and colorless |
Water insoluble substances | Not more than 0.1% |
Fumaric Acid | Not more than 1.0% |
Maleic Acid | Not more than 0.05% |
Residue on ignition | Not more than 0.1% |
Residual solvents | Meets the requirements |
Assay | Not less than 99.0% not more than 100.5% |
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.