| Function: | Chemical Medicine Raw Materal |
|---|---|
| Certification: | GMP, USP, Ep, Bp |
| Grade Standard: | Medicine Grade |
| Type: | Chemical Medicine Raw Materal |
| State: | Solid |
| Volatile: | Not Volatile |
| Samples: |
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| Customization: |
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Suppliers with verified business licenses
Audited Supplier | Batch No. | HF161021 | Quantity | 3.66kgs |
| Mfg. Date | Oct. 21, 2016 | Package | As required |
| Rep. Date | Oct. 23, 2016 | Exp. Date | Oct. 20, 2018 |
| Items | Standards | Results | |
| Appearance | White or off-white solid powder | White solid powder | |
| Identification | By IR | Complies | |
| By HPLC | Complies | ||
| Solubility | Slightly soluble in water, very slightly soluble in methanol, hardly insoluble in ethanol, acetone and acetonitrile | Complies | |
| Specific Rotation | +9.0°~ +13.0°(0.6g/100ml in DMSO) | +10.0° | |
| Loss on Drying | ≤ 0.50% | 0.25% | |
| Heavy Metal | ≤ 10ppm | Complies | |
| Residue on Ignition | ≤ 0.20% | 0.10% | |
| Enantiomer | (SS) ≤0.1% | ND | |
| Citrate | 36.2% ~ 40.0% (on dried basis) | 38.3% | |
| Residual Solvents | Petroleum ether: ≤3000ppm | ND | |
| Ethanol: ≤5000ppm | ND | ||
| Ethyl ether: ≤5000ppm | ND | ||
| Acetone: ≤5000ppm | ND | ||
| n-Butyl alcohol: ≤5000ppm | ND | ||
| Dichloromethane: ≤600ppm | ND | ||
| Related Substances | (RS+SR): ≤0.10% | ND | |
| Any single impurity: ≤0.10% | 0.05% | ||
| Total Impurities: ≤0.30% | 0.07% | ||
| Assay (HPLC basis on drying) |
99.0%~101.0% | 99.85% | |
| Reference Standard | In-house Standard | ||
| Conclusion | The product complied to In-house standard. | ||
| Storage | Preserve in tight,light-resistant containers in a cool place | ||
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Audited Supplier 
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