Fluvoxamine maleate USP Pharmaceutical API Depression made in china

Appearance

A white to almost white crystalline powder

Solubility

Sparingly soluble in water, freely soluble in 

Ethanol(96%) and in methanol

Identification

A:Infrared Absorption

B:The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.

Melting temperature

121°—123°

Loss on drying

≤0.5%

Residue on ignition

≤0.1%

Heavy metals

≤0.001%

Related compounds

5-Methoxy-1-[4-(trifluoromethyl)phenyl]-1-pentanone-(E)-O-[2-[(2-succinyl)amino]ethyl]oxime       (Limit 0.3%)

5-Methoxy-4’-(trifluoromethyl)valeropentanone-(E)-O-(2-aminoethyl) aminoethyl oxime maleate      (Limit 0.2%)

Z-isomer                                     (Limit 0.5%)

4’-(trifluoromethyl)valeropentanone-(E)- O-(2-aminoethyl) aminoethyl oxime maleate               (Limit 0.2%)

(E)-O-(2-aminoethyl)-4'-(trifluoromethyl)-α-phenyl- acetophenone oxime maleate              (Limit 0.2%)

4'-(trifluoromethyl)valeropentanone-(E)-O-(2-aminoethyl) oxime maleate                           (Limit 0.2%)

Related compounds

5-Methoxy-4'-(trifluoromethyl)valeropentanone oxime                                                     (Limit 0.2%)

5-Methoxy-4'-(trifluoromethyl)valeropentanone ketone  

(Limit 0.2%)

Unknown impurities                              (Limit 0.1%)

Total                                            (Limit 1.5%)

Assay

Not less than 98.0% and not more than 102.0% (Calculated with reference to the dried substance)