| Customization: | Available |
|---|---|
| Powder: | Yes |
| Customized: | Customized |
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| Batch No. | HF170425 | Quantity | 25kgs |
| Mfg. Date | Apr. 25, 2017 | Package | As required |
| Rep. Date | Apr. 28, 2017 | Exp. Date | Apr. 24, 2019 |
| Items | Standards | Results | |
| Appearance | White to light yellow crystalline powder | Complies | |
| Identification | It should be Nitrogen base reaction | Complies | |
| By UV | Complies | ||
| Should display the reaction of chloride differentiated | Complies | ||
| Solubility | Should dissolved in water, warm ethanol a insoluble in ether and benzene, the solution is neutral to litmus | Complies | |
| Melting Point | 178ºC~185ºC | 180.3~182.1ºC | |
| Loss on Drying | ≤ 0.50% | 0.14% | |
| Residue on Ignition | ≤ 0.15% | 0.03% | |
| Residual Solvents | DMF: ≤880ppm | ND | |
| Et.: ≤5000ppm | ND | ||
| Ace ≤5000ppm | ND | ||
| Isopr: ≤5000ppm | ND | ||
| Tolu: ≤890ppm | ND | ||
| : ≤3000ppm | ND | ||
| Related Substances | If the impurities are detected, then the total amount of the impurities should be not more than 2.0%. | Complies | |
| Assay (on the anhydrous basis) | 97.0%~103.0% | 99.67% | |
| Reference Standard | USP35 Standard | ||
| Conclusion | The product complied to USP35 standard. | ||
| Storage | Preserve in tight,light-resistant containers in a cool place | ||
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