Items | Standard | Results |
Appearance | Colorless or yellowish liquid or crystalline | Colorless liquid |
Identification / IR | Concordant with the RS spectrum | Conform |
Appearance of solution | Clear and not more intensely coloured than reference solution BY 6 | Conform |
Acidity or alkalinity | ≤ 0.05ml 0.1M HCl ≤ 0.05ml 0.1M NaOH |
< 0.05 ml < 0.05 ml |
Water | ≤ 0.5% | 0.04% |
Related substance (HPLC) Impurity A |
≤ 0.05% | <0.01% |
Related substance (GC) | ||
Impurity B (Phenol) | ≤ 0.15% | 0.03% |
Impurity C (Veratrole) | ≤ 0.2% | < 0.02% |
Impurity E (Methyl benzoate) | ≤ 0.2% | <0.02% |
Maximun unknown impurity | ≤ 0.10% | 0.02% |
Total impurities | ≤ 1.0% | 0.07% |
Assay (HPLC) (Calculate on anhydrous basis) |
97.0-102.0% | 100.2% |
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