Benoxinate Hydrochloride
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C17H28N2O3·HCl 344.88

Benzoic acid, 4-amino-3-butoxy-, 2-(diethylamino)ethyl ester, monohydrochloride.
2-(Diethylamino)ethyl 4-amino-3-butoxybenzoate monohydrochloride [5987-82-6].
» Benoxinate Hydrochloride contains not less than 98.5 percent and not more than 101.5 percent of C17H28N2O3·HCl, calculated on the dried basis.
Packaging and storage— Preserve in well-closed containers.
A: Infrared Absorption 197K: previously dried.
Solution: 15 µg per mL.
Medium: water.
C: A solution (1 in 100) responds to the tests for Chloride 191.
pH 791: between 5.0 and 6.0, in a solution (1 in 100).
Loss on drying 731 Dry it at 105 for 3 hours: it loses not more than 1.0% of its weight.
Residue on ignition 281: not more than 0.2%.
Ordinary impurities 466
Test solution: methanol.
Standard solution: methanol.
Eluant: a mixture of chloroform, cyclohexane, and diethylamine (5:4:1).
Visualization: 12.
Assay— Dissolve about 250 mg of Benoxinate Hydrochloride, accurately weighed, in a mixture of 20 mL of glacial acetic acid and 20 mL of acetic anhydride, 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 34.49 mg of C17H28N2O3·HCl.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Daniel K. Bempong, Ph.D.
Senior Scientist
(MDPS05) Monograph Development-Pulmonary and Steroids
Reference Standards Lili Wang, Technical Services Scientist
USP32–NF27 Page 1638