Packaging and storage— Preserve in tight containers.

Alcohol content, Method II 611: between 80.0% and 87.0% of C2H5OH, the dilution to approximately 2% alcohol being made with methanol instead of with water.

Residual solvents 467: meets the requirements.

Assay— Transfer 2.0 mL of Camphor Spirit to a suitable pressure bottle containing 50 mL of freshly prepared dinitrophenylhydrazine TS. Close the pressure bottle, immerse it in a water bath, and maintain at about 75 for 16 hours. Cool to room temperature, and transfer the contents to a beaker with the aid of 100 mL of 3 N sulfuric acid. Allow to stand at room temperature for not less than 12 hours, transfer the precipitate to a tared filter crucible, and wash with 100 mL of 3 N sulfuric acid followed by 75 mL of cold water in divided portions. Continue the suction until the excess water is removed, dry the crucible and precipitate at 80 for 2 hours, cool, and weigh. The weight of the precipitate so obtained, multiplied by 0.4581, represents the weight of C10H16O in the specimen taken.

Expert Committee : (MDAA05) Monograph Development-Antivirals and Antimicrobials

USP29–NF24 Page 362

Phone Number : 1-301-816-8394