| Customization: | Available |
|---|---|
| Powder: | Yes |
| Customized: | Customized |
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| Batch No. | HF170330 | Quantity | 335kgs |
| Mfg. Date | Mar. 30, 2017 | Package | As required |
| Rep. Date | Apr. 03, 2017 | Exp. Date | Mar. 29, 2019 |
| Items | Standards | Results | |
| Appearance | Light yellow to yellow slightly hygroscopic. | Complies | |
| Identification | By IR | Complies | |
| The filtrate gives reaction of chlorides. | Complies | ||
| Solubility | Sparingly soluble in water,slightly soluble in ethanol(96 percent),practically insoluble in acetone. | Complies | |
| pH | 3.9~4.6 | 4.47 | |
| Clarity | Not more than 2 turbidity standard solution turbidity | Complies | |
| Specific Optical Rotation | -125º~-138º | -130.12º | |
| Water Content | ≤ 4.50% | 0.40% | |
| Heavy Metals | ≤ 10ppm | Complies | |
| Sulphated Ash | ≤ 0.10% | 0.03% | |
| Residual Solvents | Methylene Chloride: ≤ 600ppm | ND | |
| Ethanol: ≤ 5000ppm | 71ppm | ||
| Acetic Acid: ≤ 5000ppm | 27ppm | ||
| Related Substance | Impurity A: ≤0.10% | 0.04% | |
| Impurity B: ≤0.10% | ND | ||
| Impurity C: ≤0.10% | ND | ||
| Impurity D: ≤0.10% | ND | ||
| Impurity E: ≤0.10% | ND | ||
| Unspecified impurities: ≤0.10% | 0.05% | ||
| Total impurities: ≤0.30% | 0.10% | ||
| Assay (on the anhydrous basis) | 98.0%~102.0% | 99.88% | |
| Reference Standard | BP Standard | ||
| Conclusion | The product complied to BP standard. | ||
| Storage | Preserve in tight,light-resistant containers in a cool place |
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