Packaging and storage— Preserve in tight,single-dose containers,preferably of Type Iglass,and store at controlled room temperature.The container may contain an inert gas in the headspace.

Specific gravity á841ñ: not more than 0.8035at 15.56,indicating not less than 96.8%,by weight,of C2H5OH.

Acidity— To 50mL,in a glass-stoppered flask,add 50mLof recently boiled water.Add phenolphthalein TS,and titrate with 0.020Nsodium hydroxide to a pink color that persists for 30seconds:not more than 10.0mLof 0.020Nsodium hydroxide is required for neutralization.

Other requirements— It meets the requirements for Identification,Limit of nonvolatile residue,Water-insoluble substances,Aldehydes and other foreign organic substances,Amyl alcohol and nonvolatile,carbonizable substances,UVabsorbance,Limit of acetone and isopropyl alcohol,and Methanolunder Dehydrated Alcohol,and meets the requirements under Injections á1ñ.

Expert Committee:(PA2)Pharmaceutical Analysis 2

USP28–NF23Page 62

Phone Number:1-301-816-8139