| Powder: | Yes |
|---|---|
| Customized: | Non-Customized |
| Certification: | GMP, ISO 9001, USP, BP |
| Suitable for: | Elderly, Adult |
| State: | Solid |
| Purity: | >99% |
| Samples: |
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| Customization: |
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Suppliers with verified business licenses
Audited Supplier | Batch No. | HF161026 | Quantity | 2.5kgs |
| Mfg. Date | Oct. 26, 2016 | Package | As required |
| Rep. Date | Oct. 29, 2016 | Exp. Date | Oct. 25, 2018 |
| Items | Standards | Results | |
| Appearance | White to off-white crystalline powder | Complies | |
| Identification | IR spectrum must comply with working standard spectrum | Complies | |
| Water solution must display identification of bromide test | Complies | ||
| Solubility | Easy soluble in Water and Methanol, soluble in Ethanol, slightly soluble in Acetonitrile, almost insoluble in Chloroform | Complies | |
| Appearance of Solution | Must be complies | Complies | |
| The Acidity and Alkalinity | Must be complies | Complies | |
| Loss on Drying | ≤ 0.50% | 0.07% | |
| Residue on Ignition | ≤ 0.10% | 0.08% | |
| Heavy Metals | ≤ 10ppm | Complies | |
| P3-G | ≤ 0.20% | ND | |
| Residual Solvents | Methanol: ≤3000ppm | ND | |
| Butanore: ≤5000ppm | 900ppm | ||
| Ethyl acetate: ≤5000ppm | ND | ||
| Toluene: ≤890ppm | ND | ||
| Related Substances | Impurity PID-A: ≤0.10% | ND | |
| Impurity D-I: ≤0.10% | ND | ||
| Impurity P3-F: ≤0.10% | ND | ||
| Impurity E: ≤0.10% | ND | ||
| The Maximum unknown impurity: ≤0.10% | 0.046% | ||
| Total impurities: ≤0.50% | 0.08% | ||
| Assay(on dried basis) | 99.0%~101.0% | 99.85% | |
| Reference Standard | EP7.1 Standard | ||
| Conclusion | The product complied to EP7.1 standard. | ||
| Storage | Preserve in tight,light-resistant containers in a cool place |
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