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Bromodiphenhydramine Hydrochloride
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C17H20BrNO·HCl 370.71

Ethanamine, 2-(4-bromophenyl)phenylmethoxy-N,N-dimethyl-, hydrochloride.
2-(p-Bromo--phenylbenzyl)oxy-N,N-dimethylethylamine hydrochloride [1808-12-4].
» Bromodiphenhydramine Hydrochloride contains not less than 98.0 percent and not more than 101.0 percent of C17H20BrNO·HCl, calculated on the dried basis.
Packaging and storage— Preserve in tight containers.
Identification—
B: Ultraviolet Absorption 197U—
Solution: 15 µg per mL.
Medium: 0.1 N sulfuric acid.
Absorptivities at 228 nm, calculated on the dried basis, do not differ by more than 3.0%.
Melting range 741: between 148 and 152.
Loss on drying 731— Dry it at 105 for 3 hours: it loses not more than 0.5% of its weight.
Organic volatile impurities, Method I 467: meets the requirements.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay— Dissolve about 700 mg of Bromodiphenhydramine Hydrochloride, accurately weighed, in 50 mL of glacial acetic acid, and add 10 mL of benzene and 15 mL of mercuric acetate TS. Add 2 drops of crystal violet TS, and titrate with 0.1 N perchloric acid VS to a green endpoint. Perform a blank determination, and make any necessary correction. Each mL of 0.1 N perchloric acid is equivalent to 37.07 mg of C17H20BrNO·HCl.
Auxiliary Information— Staff Liaison : Daniel K. Bempong, Ph.D., Scientist
Expert Committee : (MDPS05) Monograph Development-Pulmonary and Steroids
USP29–NF24 Page 310
Phone Number : 1-301-816-8143