Amoxapine
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C17H16ClN3O 313.78

Dibenz[b,f][1,4]oxazepine,2-chloro-11-(1-piperazinyl)-.
2-Chloro-11-(1-piperazinyl)dibenz[b,f][1,4]oxazepine [14028-44-5].
»Amoxapine contains not less than 98.5percent and not more than 101.0percent of C17H16ClN3O,calculated on the dried basis.
Packaging and storage— Preserve in tight containers.
Identification,Infrared Absorption á197Kñ.
Melting range,Class Iá741ñ: between 177and 181.
Loss on drying á731ñ Dry it at 105for 4hours:it loses not more than 0.5%of its weight.
Residue on ignition á281ñ: not more than 0.1%.
Chromatographic purity—
Standard solutions— Dissolve an accurately weighed quantity of USP Amoxapine RSin chloroform,and mix to obtain Standard preparation Ahaving a known concentration of 0.50mg per mL.Quantitatively dilute a portion of Standard solution Awith chloroform to obtain Standard solution Bhaving a known concentration of 0.25mg per mL.
Test solution— Dissolve an accurately weighed quantity of Amoxapine in chloroform to obtain a solution containing 50mg per mL.
Procedure— Separately apply 5µLof the Test solutionand each of the two Standard solutionsto a suitable thin-layer chromatographic plate (see Chromatography á621ñ),coated with a 0.2-mm layer of chromatographic silica gel mixture.Allow the spots to dry,and develop the chromatogram in a solvent system consisting of a mixture of chloroform,methanol,and ammonium hydroxide (18:2:0.1)until the solvent front has moved about three-fourths of the length of the plate.Remove the plate from the developing chamber,mark the solvent front,air-dry,examine the plate under short-wavelength UVlight,and compare the intensities of any secondary spots observed in the chromatogram of the Test solutionwith those of the principal spots in the chromatograms of the Standard solutions:no secondary spot from the chromatogram of the Test solutionis larger or more intense than the principal spot obtained from Standard solution B(0.5%),and the sum of the intensities of the secondary spots obtained from the Test solutioncorresponds to not more than 1.0%.
Assay— Transfer about 300mg of Amoxapine,accurately weighed,to a 250-mLflask,dissolve in 50mLof glacial acetic acid,and add 3drops of crystal violet TS.Titrate with 0.1Nperchloric acid VSto an emerald green endpoint.Perform a blank determination,and make any necessary correction.Each mLof 0.1Nperchloric acid is equivalent to 15.69mg of C17H16ClN3O.
Auxiliary Information— Staff Liaison:Ravi Ravichandran,Ph.D.,Senior Scientist
Expert Committee:(PA3)Pharmaceutical Analysis 3
USP28–NF23Page 142
Phone Number:1-301-816-8330