Oxprenolol Hydrochloride
2-Propanol,1-(o-allyloxyphenoxy)-3-isopropylamino-,hydrochloride. 1-(o-Allyloxyphenoxy)-3-isopropylamino-2-propanol hydrochloride [6452-73-9]. »Oxprenolol Hydrochloride contains not less than 98.5percent and not more than 101.0percent of C15H23NO3·HCl,calculated on the dried basis.
Packaging and storage
Preserve in well-closed containers.
Clarity of solution
Dissolve 1g in 10mLof water:solution is clear.
Identification
A:
Infrared Absorption á197Kñ.
B:
Asolution of it responds to the tests for Chloride á191ñ.
pHá791ñ:
between 4.0and 6.0,in a solution (1in 10).
Loss on drying á731ñ
Dry about 3g of it in vacuum at 60
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Residue on ignition á281ñ:
not more than 0.1%.
Heavy metals,Method IIá231ñ:
0.001%.
Chromatographic purity
Diluting solvent
Prepare a mixture of chloroform and dehydrated alcohol (1:1).
Standard solution A
Prepare a solution of USP Oxprenolol Hydrochloride RSin Diluting solventcontaining 20mg per mL.
Standard solution B
Dilute an accurately measured volume of Standard solution Aquantitatively,and stepwise if necessary,with Diluting solventto obtain a solution containing 0.08mg per mL.
Test solution
Transfer 200mg of it to a 10-mLvolumetric flask,dissolve in Diluting solvent,dilute with Diluting solventto volume,and mix.
Procedure
Apply separate 5-µLportions of the Test solutionand the Standard solutionsto the starting line of a suitable thin-layer chromatographic plate (see Chromatography á621ñ)coated with a 0.25-mm layer of chromatographic silica gel mixture,previously washed with methanol until the solvent front reaches the top of the plate,dried first in air and then at 100
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Organic volatile impurities,Method Iá467ñ:
meets the requirements.
Assay
Dissolve about 450mg of Oxprenolol Hydrochloride in 100mLof glacial acetic acid.Add 10mLof mercuric acetate TS,and titrate with 0.1Nperchloric acid VS,determining the endpoint potentiometrically,using a glass-calomel electrode system (with a salt bridge of a saturated solution of lithium chloride in glacial acetic acid).Perform a blank determination,and make any necessary correction.Each mLof 0.1Nperchloric acid is equivalent to 30.18mg of C15H23NO3·HCl.
Auxiliary Information
Staff Liaison:Andrzej Wilk,Ph.D.,Senior Scientific Associate
Expert Committee:(PA5)Pharmaceutical Analysis 5
USP28NF23Page 1430
Phone Number:1-301-816-8305
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