| Powder: | No |
|---|---|
| Customized: | Customized |
| State: | Liquid |
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| 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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