U.S. PHARMACOPEIA

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Gentian Violet Topical Solution
» Gentian Violet Topical Solution contains, in each 100 mL, not less than 0.95 g and not more than 1.05 g of gentian violet, calculated as hexamethylpararosaniline chloride (C25H30ClN3).
Packaging and storage— Preserve in tight containers.
Identification— A 1 in 5 dilution responds to Identification tests B and C under Gentian Violet.
Solution of residue in alcohol— Evaporate 10 mL on a steam bath to dryness: the residue dissolves completely in 10 mL of alcohol.
Alcohol content 611: between 8.0% and 10.0% of C2H5OH.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay— Pipet 25 mL of Topical Solution into a 300-mL conical flask, and proceed as directed in the Assay for Gentian Violet, beginning with “add 25 mL of water.”
Auxiliary Information— Staff Liaison : Behnam Davani, Ph.D., MBA, Senior Scientist
Expert Committee : (MDAA05) Monograph Development-Antivirals and Antimicrobials
USP29–NF24 Page 1001
Phone Number : 1-301-816-8394