| Test | Specification...BP |
| Description | It occurs as white or almost white, crystalline powder or colourless crystals |
| Identification
Test (A) Test (B) Test (C) |
A) Melting Point: 115 °C to 118 °C. B) Infrared absorption spectrophotometry. C) Thin-layer chromatography |
| Solubility | Very slightly soluble in water, freely soluble in ethanol (96%) and in methanol. |
| Appearance of solution | Solution S is clear and not more intensely coloured than reference solution BY6 |
| Acidity | Specified Test |
| Related substances
a. impurity A b. unspecified impurities c. total d. disregard limit |
Maximum 0.5 % Maximum 0.5 % Maximum 1.0 % Maximum 0.1 % |
| Sulfated ash | Maximum 0.1 % |
| Assay | Not less than 98.0% and not more than 102.0% |
| Test | Specification...USP |
| Appearance | It occurs as small, colorless crystals or white powder. |
| Identification
Test A Test B |
a. Infrared absorption spectrophotometry b. Melting point –Between 115°C to 118°C |
| Solubility | Freely soluble in acetone, in alcohol, in ether, and in propylene glycol; slightly soluble in water and in glycerin. |
| Color of Solution | The Sample solution is clear and not more intensely colored than alcohol or the Comparison solution. |
| Acidity | Not More than 0.1 mL is required to produce a blue color. |
| Related substances
p-Hydroxybenzoic acid Unspecified impurity Total impurity |
Not more than 0.5% Not more than 0.5% Not more than 1.0% |
| Residue on Ignition | Not more than 0.1% |
| Residual Solvents | Meets the requirements. |
| Assay | Not less than 98.0% and not more than 102.0% of C9H10O3 |
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.