| Test | Specification...BP |
| Characters | It occurs as a white or almost white powder |
| Identification
Test A Test B |
(a) Infrared absorption spectrophotometry (b)Thin Layer Chromatography |
| Solubility | Freely Soluble in water, slightly soluble in glacial acetic acid, in anhydrous ethanol and in methanol. |
| Melting Point | About 125OC with decomposition |
| Appearance of solution | The solution is clear and not more intensely colored than reference solution Y5 |
| Specific optical rotation | +23.0O to +29.0O |
| Total Ash | Not more than 0.2% |
| Heavy Metals | Not more than 20 ppm |
| Reducing Sugars (as Glucose) | Not more than 0.2% |
| Water | Not more than 5.0% |
| Assay | Not less than 98.0% and not more than 102.0% (anhydrous substances) |
| Test | Specification...EP |
| Characters | It occurs as a white or almost white powder |
| Identification
Test A Test B |
(a) Infrared absorption spectrophotometry (b)Thin Layer Chromatography |
| Solubility | Freely Soluble in water, slightly soluble in glacial acetic acid, in anhydrous ethanol and in methanol. |
| Melting Point | About 125OC with decomposition |
| Appearance of solution | The solution is clear and not more intensely colored than reference solution Y5 |
| Specific optical rotation | +23.0O to +29.0O |
| Total Ash | Not more than 0.2% |
| Reducing Sugars (as Glucose) | Not more than 0.2% |
| Water | Not more than 5.0% |
| Microbial Contamination
TAMC TYMC |
Not more than 103 cfu/g Not more than 102 cfu/g |
| Assay | Not less than 98.0% and not more than 102.0% (anhydrous substances) |
| Test | Specification...USP |
| Characters | White or almost white powder. |
| Identification
Test A Test B |
(a) Infrared absorption spectrophotometry. (b) Thin-layer chromatography |
| Solubility | Freely soluble in water, slightly soluble in glacial acetic acid, in anhydrous ethanol and in methanol. |
| MP | About 125 °C |
| Optical rotation | Between + 23.0 to + 29.0 |
| Articles of Botanical Origin | Maximum 0.2% |
| Reducing sugars | Maximum 0.2% |
| Heavy metals | Maximum 20 ppm |
| Water | Maximum 5.0% |
| Assay | Not less than 98.0% and more than 102.0%, on the 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.