Test | Specification...BP |
Characters | It occurs as a yellowish-white powder or translucent granules. |
Identification
Test A Test B |
a. Infrared Absorption Spectrophotometry b. Viscosity |
Solubility | Soluble in water, slightly soluble in ethanol, practically insoluble in acetone. |
Appearance of solution | Solution S is clear and not more intensely coloured than reference solution Y7 |
pH | 4.5 to 6.5 for solution S. |
Viscosity | 85 % to 115 % of the value stated on the label. |
Acid value | Not more than 3.0 |
Ester value | 90 % to 110 % of the value stated on the label. |
Heavy metals | Not more than 10 ppm |
Loss on drying | Not more than 5.0% |
Sulfated ash | Not more than 1.0% |
Test | Specification...USP |
Characters | Clear, yellowish or brownish, oily liquid. |
Solubility | It is soluble in water |
Viscocity | between 85.0% and 115.0% |
pH | between 5.0 and 8.0 |
Loss on drying | not more than 5.0% |
Residue on ignition | not more than1.0% |
Heavy metals | not more than 10 µg per g |
Acid Value | not more than 3.0 |
Water-insoluble substance | not more than 0.1% |
methanol and methyl acetate | not more than 1.0% |
Organic Volatile impurity | Passes test |
Residual Solvents | Meets the Requirements |
Assay | Not less than 85% and not more than 115% |
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.