| Test | Specification...BP |
| Characters | White or almost white, crystalline or granular powder, slightly efflorescent. |
| Identification
Test (A) Test (B) Test(C) |
(a)Test for loss on drying (b)It gives the reaction of Lactates (c)It gives the reaction of Calcium |
| Solubility | Soluble in water, freely soluble in boiling water, very slightly soluble in ethanol (96%) |
| Appearance of solution | The solution is not more opalescent than the reference suspension and not more intensely colored than the reference solution BY6 |
| Acidity or alkalinity | Specified Test |
| Chlorides | Not more than 200 ppm |
| Sulfates | Not more than 400 ppm |
| Barium | Specified Test |
| Iron | Not more than 50ppm |
| Magnesium and alkali salts | Not more than 1% |
| Heavy metals | Not more than 10ppm |
| Loss on drying | Between 22.0% and 27.0% |
| Assay | Not less than 98.0% and not more than 102.0% (dried substances) |
| Test | Specification...IP |
| Appearance | White granules or powder; odorless or with slight but not unpleasant odor. |
| Solubility | Soluble in water, freely soluble water in hot water, very slightly soluble in ethanol (95%) |
| Appearance of solution | The solution is not more opalescent than the reference suspension and not more intensely colored than the standard solution |
| Acidity and alkalinity | Passes test |
| Arsenic | Maximum 2ppm |
| Heavy metals | Maximum 20ppm |
| Iron | Maximum 80ppm |
| Chlorides | Maximum 200ppm |
| Sulphates | Maximum 0.15% |
| Reducing sugars | Passes test |
| Loss on drying | Maximum 30% |
| Assay | Not less than 98.0% and not more than 102.0% |
| Test | Specification...USP |
| Characters | It appears as a white practically odorless granules or powder. The pentahydrate is somewhat efflorescent and at 120˚ becomes anhydrous. |
| Identification
Test (A) Test (B) |
a) It gives the reaction of Calcium Infrared Absorption |
| Solubility | Soluble in water and insoluble in alcohol. |
| Magnesium and alkali salts | Not more than 1% |
| Volatile fatty acids | The mixture does not emit an odor of volatile fatty acids |
| Acidity | Specified test. |
| Loss on drying | 22.0–27.0% |
| Heavy metals | Maximum 20ppm |
| Residual Solvents | Meets the requirements |
| Assay | Not less than 98.0% and not 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.