Calcium Levulinate Dihydrate BP
General Specifications
| Test | Specification |
| Characters | It occurs as a white or almost white, crystalline powder. |
| Identification
Test A Test B Test C Test D Test E |
(a) Infrared absorption spectrophotometry. (b) Thin-layer chromatography (c) Specified test. The melting point is 203 °C to 210 °C. (d) Gives reaction of calcium (e) Test for Loss on drying |
| Solubility | Freely soluble in water, very slightly soluble in ethanol (96%), practically insoluble in methylene chloride. |
| Appearance of solution | Solution is clear and not more intensely colored than reference solution Y6 |
| pH | Between 6.8 to 7.8 |
| Oxidisable substances | Specified test. After 5 min, the violet color of the mixture is still visible. |
| Sucrose and reducing sugars | Specified test. No red precipitate is formed. |
| Chlorides | Not more than 50 ppm |
| Sulfates | Not more than 200 ppm |
| Magnesium and alkali metals | Not more than 1.0% |
| Loss on drying | Between 11.0 % to 12.5% |
| Assay | Not less than 98.0% and more than 101.0%
(dried 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.
