China Made Gemfibrozil Powder Pharmaceutical Chemicals CAS 25812-30-0, Find details about China Gemfibrozil, Gemfibrozil Powder from China Made Gemfibrozil Powder Pharmaceutical Chemicals CAS 25812-30-0
Items | Standards | Results | |
Appearance | White or off-white solid powder | Complies | |
Identification | By IR | Complies | |
By HPLC | Complies | ||
Solubility | Soluble in DMF, sparingly soluble in THF, slightly soluble in methanol and acetonitrile, very sightly soluble in ethanol and dichloromethane, insoluble in water. | Complies | |
Polymorphic Form | Polymorphic form 1 | Complies | |
Melting Point | 211ºC~216ºC | 212.6ºC~214.5ºC | |
Water Content | ≤ 0.50% | 0.12% | |
Heavy Metals | ≤ 20ppm | Complies | |
Residue on Ignition | ≤ 0.20% | 0.08% | |
Related Substance | Any single impurity: ≤0.10% | 0.05% | |
Total Impurities: ≤1.00% | 0.18% | ||
(on the anhydrous basis) Assay | 98.0%~102.0% | 99.88% | |
Particle Size | D90: ≤100µm | Complies |