Test | Specification...BP |
Characters | It occurs as amorphous, white or almost white powder, hygroscopic. |
Identification Test A Test B | (a) Thin layer chromatography. (b) It gives the reaction of magnesium |
Solubility | Very soluble in water, soluble in methanol, practically insoluble in methylene chloride. |
Appearance of solution | Solution is clear and not more intensely coloured than reference solution B8 |
pH | Between 5.5 to 7.0 |
Specific optical rotation | Between -23.3 to -26.5 (anhydrous substances) |
Related substances -Impurity B -Unspecified impurities -Total of other impurities | Not more than 1.0% Not more than 0.10% Not more than 0.5% |
Impurity A | Not more than 0.6% |
Chlorides | Not more than 500 ppm |
Nitrates | Not more than 200 ppm |
Sulphates | Not more than 0.1% |
Arsenic | Not more than 2 ppm |
Iron | Not more than 200 ppm |
Water | Not more than 8.0% |
Assay | Not less than 8.49% and not more than 8.84% of Mg (anhydrous 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.
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.