Customization: | Available |
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Function: | Antineoplastic, Chemical Medicine Raw Materal |
Certification: | GMP, USP, Ep, Bp |
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Audited by an independent third-party inspection agency
Batch No. | HF170612 | Quantity | 12kgs |
Mfg. Date | Jun. 12, 2017 | Package | As required |
Rep. Date | Jun. 15, 2017 | Exp. Date | Jun. 11, 2019 |
Items | Standards | Results | |
Appearance | White or off-white crystalline powder | Complies | |
Identification | By IR | Complies | |
By HPLC | Complies | ||
Solubility | slightly soluble in water | Complies | |
Water Content | 3.00%~4.40% | 3.60% | |
Melting Point | 69~75ºC | 73.4~74.7ºC | |
Heavy Metal | ≤20ppm | Complies | |
Isomer | ≤0.15% | 0.03% | |
13.6%~16.6% | 15.3% | ||
Purity(HPLC) | ≥99.50% | 99.88% | |
Assay (HPLC basis on drying) |
98.0%~102.0% | 99.96% | |
Particle Size | D90: ≤50µm, D98: ≤80µm | 30µm, 38µm | |
Reference Standard | In-house Standard | ||
Conclusion | The product complied to In-house standard. | ||
Storage | Preserve in tight,light-resistant containers in a cool place |