Amoxapine
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.
Loss on drying á731ñ
Dry it at 105
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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
USP28NF23Page 142
Phone Number:1-301-816-8330
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