| Customization: | Available |
|---|---|
| Function: | Chemical Medicine Raw Materal |
| Certification: | GMP, Reach, FDA |
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| Batch No. | HF160301 | Quantity | 58kgs |
| Mfg. Date | Mar. 01, 2016 | Package | As required |
| Rep. Date | Mar. 04, 2016 | Exp. Date | Feb. 28, 2018 |
| Items | Standards | Results | |
| Appearance | White or off-white crystalline powder | Complies | |
| Identification | By IR | Complies | |
| By HPLC | Complies | ||
| Solubility | Slightly soluble in water, freely soluble in ethanol and acetone, soluble in 2-propanol and insoluble in heptane | Complies | |
| Water Content | ≤0.50% | 0.22% | |
| Residue on Ignition | ≤0.20% | 0.15% | |
| Melting Point | 120ºC~130ºC | 121.0ºC~122.0ºC | |
| Polymorphic Identity | XRD | Form 6 | |
| Heavy Metal | ≤20ppm | Complies | |
| Residue Solvent | Acetone: ≤5000ppm | ND | |
| Toluene: ≤890ppm | 137.7ppm | ||
| Dichloromethane: ≤600ppm | 255.1ppm | ||
| Tetrahydrofuran: ≤720ppm | 345.4ppm | ||
| ter-Butylmethylether: ≤5000ppm | ND | ||
| Related Substances | Any Single Impurity ≤0.10% | 0.04% | |
| Total Impurities: ≤0.50% | 0.08% | ||
| Particle Size Distribution | D90: ≤ 45µm | Complies | |
| Assay | 98.0~101.5% | 99.30% | |
| Reference Standard | In-house Standard | ||
| Conclusion | The product complied to In-house standard. |
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