Customization: | Available |
---|---|
Powder: | Yes |
Customized: | Non-Customized |
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Audited by an independent third-party inspection agency
Batch No. | HF161008 | Quantity | 25.8kgs |
Mfg. Date | Oct. 08, 2016 | Package | As required |
Rep. Date | Oct. 11, 2016 | Exp. Date | Oct. 07, 2018 |
Items | Standards | Results | |
Appearance | White or off-white crystalline powder | Complies | |
Identification | By IR | Complies | |
By HPLC | Complies | ||
Solubility | Very slightly soluble in water, freely soluble in acetone and methylene chloride | Complies | |
Water Content | ≤ 4.00% | 0.25% | |
Heavy Metals | ≤ 10ppm | Complies | |
Residue on Ignition | ≤ 0.10% | 0.07% | |
Optical Isomer | ≤ 0.50% | ND | |
Related Substances | Impurity B: ≤0.20% | ND | |
Impurity C: ≤0.20% | 0.07% | ||
Impurity D: ≤0.10% | 0.06% | ||
Impurity F: ≤0.10% | ND | ||
Any unspecified impurity: ≤0.10% | Complies | ||
Total Impurities: ≤0.50% | 0.14% | ||
Purity(HPLC) | ≥99.0% | 99.86% | |
Assay (on the anhydrous basis) | 97.5%~102.0% | 99.92% | |
Reference Standard | In-house Standard | ||
Conclusion | The product complied to In-house standard. | ||
Storage | Preserve in tight,light-resistant containers in a cool place |