| Customization: | Available |
|---|---|
| Powder: | Yes |
| Customized: | Non-Customized |
|
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| Batch No. | HF160612 | Quantity | 6.5kgs |
| Mfg. Date | Jun. 12, 2016 | Package | As required |
| Rep. Date | Jun. 15, 2016 | Exp. Date | Jun. 11, 2018 |
| Items | Standards | Results | |
| Appearance | White or almost white crystals or crystalline powder | Complies | |
| Identification | Specific optical rotation | Complies | |
| By IR | Complies | ||
| It gives reaction of bromides | Complies | ||
| Solubility | Slightly soluble in water | Complies | |
| Appearance of Solution | Solution S is clear and not more intensely coloured than reference solution BY7 | Complies | |
| Specific Optical Rotation | +30.5°~+35.0° | +32.3° | |
| Water Content | ≤ 4.0% | 1.30% | |
| Sulfated Ash | ≤ 0.10% | 0.046% | |
| Related Substances | Impurity A: ≤0.25% | ND | |
| Impurity C: ≤0.25% | 0.04% | ||
| Impurity D: ≤0.25% | 0.018% | ||
| Impurity E: ≤0.25% | ND | ||
| Impurity B(TLC): ≤0.25% | ND | ||
| Any other unspecified impurity: ≤0.10% | 0.03% | ||
| Total inpurities: ≤0.70% | 0.16% | ||
| Bacterial Endotoxins | Not more than 10EU/mg of Vecurium Bromide | Complies | |
| Assay (HPLC basis on drying) |
99.0%~101.0% | 99.88% | |
| Reference Standard | EP8.0 Standard | ||
| Conclusion | The product complied to EP8.0 standard. | ||
| Storage | In an airtight container,protected from light and moisture | ||
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