USP Monographs: Phenoxybenzamine Hydrochloride

Phenoxybenzamine Hydrochloride

C18H22ClNO·HCl

340.29

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 98.0 percent and not more than 101.0 percent of C18H22ClNO·HCl, calculated on the dried basis.

Packaging and storage— Preserve in well-closed containers.

USP Reference standards

— USP Phenoxybenzamine Hydrochloride RS.

Identification—

A: Infrared Absorption

197K

B: Ultraviolet Absorption

197U

—

Solution: 1 mg per mL.

Medium: methanol.

Absorptivities at 275 nm, calculated on the dried basis, do not differ by more than 3.0%.

Melting range, Class I

741

: between 136

and 141

Loss on drying

731

— Dry it in vacuum at 60

for 2 hours: it loses not more than 0.5% of its weight.

Ordinary impurities

466

—

Test solution: methanol.

Standard solution: methanol.

Eluant: a mixture of toluene and acetone (1:1).

Visualization: 1.

Organic volatile impurities, Method V

467

: meets the requirements.

Solvent— Use dimethyl sulfoxide.

Residual solvents

467

: meets the requirements.

(Official January 1, 2007)

Assay— Dissolve about 500 mg of Phenoxybenzamine Hydrochloride, accurately weighed, in 50 mL of glacial acetic acid, add 15 mL of mercuric acetate TS, and titrate with 0.1 N perchloric acid VS, determining the endpoint potentiometrically. Perform a blank determination, and make any necessary correction. Each mL of 0.1 N perchloric acid is equivalent to 34.03 mg of C18H22ClNO·HCl.

Auxiliary Information— Staff Liaison : Elena Gonikberg, Ph.D., Scientist

Expert Committee : (MDGRE05) Monograph Development-Gastrointestinal Renal and Endocrine

USP29–NF24 Page 1703

Phone Number : 1-301-816-8251


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