| Customization: | Available |
|---|---|
| Function: | Specialist Drugs |
| Certification: | Reach |
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| Items | Standards | ||
| Description | White or almost white crystalline powder | ||
| Solubility | Slightly soluble in water, very slightly soluble in methanol, practically insoluble in ethanol | ||
| Identification | IR vs standard | ||
| Test for specific optical rotation | |||
| Appearance of Solution | The solution is clear and colourless | ||
| Acidity | Not more than 0.6 mL of 0.01M NaOH is required to change the colour of the indicator to pink | ||
| Specific Optical Rotation | +74.5°~+78.0° | ||
| Related Substances | Impurity A: ≤ 0.15% | ||
| Impurity B: ≤ 0.15% | |||
| Impurity C: ≤ 0.15% | |||
| Any other impurity: ≤ 0.10% | |||
| Total of other impurities: ≤ 0.15% | |||
| Total of impurities: ≤ 0.30% | |||
| Impurity D | ≤ 0.15% | ||
| Solvents Residue | Ethanol: < 5000ppm | ||
| Silver | ≤ 5ppm | ||
| Loss on Drying | ≤ 0.50% | ||
| Assay(Dried Substances) | 98.0% ~ 102.0% | ||
| Bacterial Endotoxins | ≤ 1.0 EU/mg | ||
| Reference Standard | EP 8.0 Standard | ||
| Conclusion | The product complied to EP 8.0 standard. | ||
| Storage | Preserve in tight,light-resistant containers in a cool place | ||
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