Phenoxybenzamine Hydrochloride
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Benzenemethanamine,N-(2-chloroethyl)-N-(1-methyl-2-phenoxyethyl)-,hydrochloride.
N-(2-Chloroethyl)-N-(1-methyl-2-phenoxyethyl)benzylamine hydrochloride [63-92-3].
»Phenoxybenzamine Hydrochloride contains not less than 98.0percent and not more than 101.0percent of C18H22ClNO·HCl,calculated on the dried basis.
Packaging and storage—
Preserve in well-closed containers.
Identification—
A:
Infrared Absorption á197Kñ.
Solution:
1mg per mL.
Medium:
methanol.
Absorptivities at 275nm,calculated on the dried basis,do not differ by more than 3.0%.
Loss on drying á731ñ—
Dry it in vacuum at 60
for 2hours:it loses not more than 0.5%of its weight.
for 2hours:it loses not more than 0.5%of its weight.
Ordinary impurities á466ñ—
Test solution:
methanol.
Standard solution:
methanol.
Eluant:
a mixture of toluene and acetone (1:1).
Visualization:
1.
Organic volatile impurities,Method Vá467ñ:
meets the requirements.
Solvent—
Use dimethyl sulfoxide.
Assay—
Dissolve about 500mg of Phenoxybenzamine Hydrochloride,accurately weighed,in 50mLof glacial acetic acid,add 15mLof mercuric acetate TS,and titrate with 0.1Nperchloric acid VS,determining the endpoint potentiometrically.Perform a blank determination,and make any necessary correction.Each mLof 0.1Nperchloric acid is equivalent to 34.03mg of C18H22ClNO·HCl.
Auxiliary Information—
Staff Liaison:Elena Gonikberg,Ph.D.,Scientist
Expert Committee:(PA4)Pharmaceutical Analysis 4
USP28–NF23Page 1533
Phone Number:1-301-816-8251