China Fluvoxamine Maleate 61718-82-9, Find details about China Fluvoxamine Maleate, 61718-82-9 from Fluvoxamine Maleate 61718-82-9
Items | Standards | Results |
Appearance | A white to almost white crystalline powder | Complies |
Identification | By IR | Complies |
By HPLC | ||
Solubility | Sparingly soluble in water, freely soluble in Ethanol(96%) and in methanol | Complies |
Melting Point | 121ºC~123ºC | 121.6ºC~122.5ºC |
Loss on Drying | ≤ 0.50% | 0.18% |
Residual of Ignition | ≤ 0.10% | 0.06% |
Heavy Metals | ≤ 10ppm | Complies |
Related Substances | 5-Methoxy-1-[4-(trifluoromethyl)phenyl]-1-pentanone-(E)-O-[2-[(2-succinyl)amino]ethyl]oxime: ≤ 0.30% | 0.07% |
5-Methoxy-4'-(trifluoromethyl)valerophenone(E)-O-(2-aminoethyl)aminoethyl oxime maleate: ≤ 0.20% | ND | |
Z-isomer: ≤ 0.50% | 0.08% | |
4'-(Trifluoromethyl)valerophenone(E)-O-2-(2-aminoethyl)aminoethyl oxime maleate: ≤ 0.20% | ND | |
(E)-O-2-(2-Aminoethyl)-4-(trifluoromethyl)-phenyl-acetophenone oxime maleate: ≤ 0.20% | ND | |
4'-(Trifluoromethyl)valerophenone(E)-O-(2-aminoethyl) oxime maleate: ≤ 0.20% | ND | |
5-Methoxy-4'-(trifluoromethyl)valerophenone oxime: ≤ 0.20% | 0.09% | |
5-Methoxy-4'-(trifluoromethyl)valerophenone ketone: ≤ 0.20% | 0.06% | |
Umknown single impurity: ≤0.10% | 0.02% | |
Total impurities: ≤1.0% | 0.32% | |
Assay (HPLC basis on drying) | 98.0%~102.0% | 99.82% |
Reference Standard | USP 34 Standard | |
Conclusion | The product complied to USP 34 standard. | |
Storage | Preserve in tight,light-resistant containers in a cool place |