- Min.Order :0 Metric Ton
- Purity: 97.0%~103.0%
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USP34
| Items | Specifications | Results |
| Appearance | White to practically white crystalline powder | White crystalline powder |
| Melting | 240°C | 239°C |
| Identification | A:IR | Complies |
| B:UV | Complies | |
| C: Positive reaction | Complies | |
| Solubility | Practically insoluble in water sparingly soluble in alcohol, in dioxane, and in methanol; slightly soluble in acetone and in chloroform; very slightly soluble in ether | Complies |
| Specific rotation | +79o~+86o | +82.7o |
| Loss on drying | ≤1.0% | 0.10% |
| Residue on ignition | ≤0.2% | 0.03% |
| Chromatographic purity | A: Individual impurity ≤1.0% | 0.40% |
| B: Total impurities≤2.0% | 1.10% | |
| Assay | 97.0~103.0% | 99.80% |
| Conclusion | The results conforms to the USP34 | |
EP7
| Items | Specifications | Results |
| Chararcter | white or almost white crystalline powder | almost white crystalline powder |
| Specific optical rotation | +79°~+86° | +83.4° |
| Identification | ||
| A: Complies by IR | Conforms | |
| B: Complies by TLC | conforms | |
| Test | ||
| Related substances | individual impurity NMT 0.5% | 0.0027 |
| Total impurities NMT 2.0% | 0.0122 | |
| Loss on drying | NMT 0.5% | 0.002 |
| Methanol | NMT 3000PPM | Undetected |
| Ethanol | NMT 5000PPM | 1620PPM |
| Acetone | NMT 5000PPM | Undetected |
| Ethyl Aetate | NMT 5000PPM | 19PPM |
| Assay | Contain 97% to 103% of C22H30O6 Calculated on the dried basis | 0.995 |
| Conclusion | The results can conforms with EP7 |
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