Item | Standard | Result |
Characters | A white, or almost white, crystalline powder or white or colourless, acicular crystals, slightly soluble in water, freely soluble in ethanol (96 percent), sparingly soluble in methylene chloride | Complies |
Indentification | A. Melting point 158ºC-161ºC | 158.5ºC-160.3ºC |
B. The IR spectrum of samples complies with Salicylic acid CRS | Complies |
Appearance of solution | Solution is clear and colourless | Clear |
Chlorides | NMT100ppm | <100PPM |
Sulfates | NMT200ppm | <200PPM |
Heavy metals | NMT20ppm | <20PPM |
Loss on drying | NMT0.5% | 0.02% |
Residue on drying | NMT0.05% | 0.02% |
Related substances | 4-hydroxybenzoic acid ≤0.1% | 0.004% |
4-hydroxyisophthalic acid≤0.05% | 0.002% |
Phenol≤0.02% | N.D. |
Any other impurities≤0.05% | N.D. |
Total impurities≤0.2% | 0.005% |
Assay (on dried basis) | Contains C7H6O3 99.0%-100.5% | 99.60% |
Conclusion | The Product Complies with the standard of BP2020/EP10.0/USP NF2021. |