Packaging and storage
Preserve in partially-filled containers having a small vent in the closure, and store in a cool place.
Labeling
Label it to indicate the name and amount of any added preservative. The label states that this article is not intended for direct administration to humans or animals.
Acidity
Dilute 25 g with water to 250 mL, and mix thoroughly. Take 25 mL of the solution, add phenolphthalein TS, and titrate with 0.10 N sodium hydroxide: not more than 2.5 mL is required for neutralization.
Chloride 221:
1.5 g diluted with water to 25 mL shows no more chloride than 0.10 mL of 0.020 N hydrochloric acid (0.005%).
Other requirements
It responds to the
Identification test and meets the requirements of the tests for
Nonvolatile residue,
Heavy metals, and
Limit of preservative (90 mL of it being used) under
Hydrogen Peroxide Topical Solution.
Assay
Accurately weigh about 1 mL of Concentrate in a tared 100-mL volumetric flask, dilute with water to volume, and mix. To 20.0 mL of this solution add 20 mL of 2 N sulfuric acid, and titrate with 0.1 N potassium permanganate VS. Each mL of 0.1 N potassium permanganate is equivalent to 1.701 mg of H2O2.
Auxiliary Information
Staff Liaison :
Behnam Davani, Ph.D., MBA, Senior Scientist
Expert Committee : (MDAA05) Monograph Development-Antivirals and Antimicrobials
USP29NF24 Page 1080
Pharmacopeial Forum : Volume No. 30(5) Page 1629
Phone Number : 1-301-816-8394