Bromodiphenhydramine Hydrochloride
;)
Ethanamine,2-(4-bromophenyl)phenylmethoxy-N,N-dimethyl-,hydrochloride.
2-(p-Bromo-a-phenylbenzyl)oxy-N,N-dimethylethylamine hydrochloride [1808-12-4].
»Bromodiphenhydramine Hydrochloride contains not less than 98.0percent and not more than 101.0percent of C17H20BrNO·HCl,calculated on the dried basis.
Packaging and storage—
Preserve in tight containers.
Identification—
A:
Infrared Absorption á197Kñ.
B:
Ultraviolet Absorption á197Uñ—
Solution:
15µg per mL.
Medium:
0.1Nsulfuric acid.
Absorptivities at 228nm,calculated on the dried basis,do not differ by more than 3.0%.
Loss on drying á731ñ—
Dry it at 105
for 3hours:it loses not more than 0.5%of its weight.
for 3hours:it loses not more than 0.5%of its weight.
Organic volatile impurities,Method Iá467ñ:
meets the requirements.
Assay—
Dissolve about 700mg of Bromodiphenhydramine Hydrochloride,accurately weighed,in 50mLof glacial acetic acid,and add 10mLof benzene and 15mLof mercuric acetate TS.Add 2drops of crystal violet TS,and titrate with 0.1Nperchloric acid VSto a green endpoint.Perform a blank determination,and make any necessary correction.Each mLof 0.1Nperchloric acid is equivalent to 37.07mg of C17H20BrNO·HCl.
Auxiliary Information—
Staff Liaison:Karen A Russo,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 285
Phone Number:1-301-816-8379