Hydroxyamphetamine Hydrobromide Ophthalmic Solution
» Hydroxyamphetamine Hydrobromide Ophthalmic Solution is a sterile, buffered, aqueous solution of Hydroxyamphetamine Hydrobromide. It contains not less than 95.0 percent and not more than 105.0 percent of the labeled amount of C9H13NO·HBr. It contains a suitable antimicrobial agent.
Packaging and storage— Preserve in tight, light-resistant containers.
A: Dissolve about 500 mg of ammonium molybdate in 10 mL of sulfuric acid, and add 0.2 mL of Ophthalmic Solution: an intense blue color is produced (distinction from similar amino compounds such as amphetamine and methamphetamine, which, lacking a phenolic hydroxyl, do not undergo this reaction).
B: The dried diacetylhydroxyamphetamine obtained in the Assay melts between 96 and 100 (see Class I under Melting Range or Temperature 741), but the range between beginning and end of melting does not exceed 2.0.
C: It responds to Identification test D under Hydroxyamphetamine Hydrobromide.
D: Dilute a volume of Ophthalmic Solution, equivalent to about 50 mg of hydroxyamphetamine hydrobromide, with 0.01 N hydrochloric acid to 25 mL, and proceed as directed under Identification—Organic Nitrogenous Bases 181, using sodium carbonate TS in place of 1 N sodium hydroxide, beginning with “Transfer the liquid to a separator”: the Ophthalmic Solution meets the requirements of the test.
Sterility 71: meets the requirements.
pH 791: between 4.2 and 6.0.
Assay— Transfer an accurately measured volume of Ophthalmic Solution, equivalent to about 100 mg of hydroxyamphetamine hydrobromide, to a 125-mL separator. Wash the solution with 15 mL of chloroform, and discard the washing. Rinse the stopper and the mouth of the separator with a few drops of water. Add 1.05 g of sodium bicarbonate, preventing it from coming in contact with the mouth of the separator, and swirl until most of the bicarbonate has dissolved. By means of a 1-mL syringe, rapidly inject 0.5 mL of acetic anhydride directly into the contents of the separator. Immediately insert the stopper in the separator, and shake vigorously until the evolution of carbon dioxide has ceased (7 to 10 minutes), releasing the pressure as necessary through the stopcock. Allow to stand for 5 minutes, and extract the solution with five 10-mL portions of chloroform, filtering each extract through a pledget of cotton, previously washed with chloroform, into a tared 100-mL beaker. Evaporate the combined chloroform extracts on a steam bath in a current of air or stream of nitrogen to dryness. Dry the residue at 80 for 90 minutes, cool in a desiccator, and weigh. The weight of the diacetylhydroxyamphetamine so obtained, multiplied by 0.9866, represents the weight of C9H13NO·HBr in the volume of Ophthalmic Solution taken.
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Topic/Question Contact Expert Committee
Monograph Feiwen Mao, M.S.
(MDOOD05) Monograph Development-Ophthalmics Oncologics and Dermatologicals
Reference Standards Lili Wang, Technical Services Scientist
71 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
(MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 2592