Packaging and storage— Preserve in tight, light-resistant containers, at a temperature not exceeding 30.

Alcohol content, Method I 611: between 62.0% and 68.0% of C2H5OH.

Residual solvents 467: meets the requirements.

Assay for total NH3— Transfer 10.0 mL to a 250-mL conical flask containing about 50 mL of water. Add 30.0 mL of 0.5 N sulfuric acid VS, and boil until the solution becomes clear. Cool, add methyl red TS, and titrate the excess acid with 0.5 N sodium hydroxide VS. Perform a blank determination (see Residual Titrations under Titrimetry 541). Each mL of 0.5 N sulfuric acid is equivalent to 8.515 mg of NH3.

Assay for ammonium carbonate— Transfer 10.0 mL to a flask of about 300-mL capacity. Add 30 mL of 0.5 N sodium hydroxide, and boil the mixture, replacing the water lost by evaporation, until the vapors no longer turn moistened red litmus paper blue. Cool, dilute with 100 mL of cold, carbon dioxide-free water, add about 6 drops of phenolphthalein TS, then add just enough 0.5 N sulfuric acid VS to discharge the color of the phenolphthalein. Add methyl orange TS, and titrate with 0.5 N sulfuric acid VS. Perform a blank determination (see Residual Titrations under Titrimetry 541). Each mL of 0.5 N sulfuric acid consumed in the titration with methyl orange TS is equivalent to 48.04 mg of (NH4)2CO3.

Expert Committee : (MDPS05) Monograph Development-Pulmonary and Steroids

USP29–NF24 Page 150

Phone Number : 1-301-816-8143