Hydroxyamphetamine Hydrobromide Ophthalmic Solution
»Hydroxyamphetamine Hydrobromide Ophthalmic Solution is a sterile,buffered,aqueous solution of Hydroxyamphetamine Hydrobromide.It contains not less than 95.0percent and not more than 105.0percent of the labeled amount of C9H13NO·HBr.It contains a suitable antimicrobial agent.
Packaging and storage—
Preserve in tight,light-resistant containers.
Identification—
A:
Dissolve about 500mg of ammonium molybdate in 10mLof sulfuric acid,and add 0.2mLof 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 Assaymelts between 96
and 100(see Class Iunder Melting Range or Temperature á741ñ),but the range between beginning and end of melting does not exceed 2.0.
and 100(see Class Iunder Melting Range or Temperature á741ñ),but the range between beginning and end of melting does not exceed 2.0.
D:
Dilute a volume of Ophthalmic Solution,equivalent to about 50mg of hydroxyamphetamine hydrobromide,with 0.01Nhydrochloric acid to 25mL,and proceed as directed under Identification—Organic Nitrogenous Bases á181ñ,using sodium carbonate TSin place of 1Nsodium hydroxide,beginning with “Transfer the liquid to a separator”:the Ophthalmic Solution meets the requirements of the test.
Sterility á71ñ:
meets the requirements.
pHá791ñ:
between 4.2and 6.0.
Assay—
Transfer an accurately measured volume of Ophthalmic Solution,equivalent to about 100mg of hydroxyamphetamine hydrobromide,to a 125-mLseparator.Wash the solution with 15mLof chloroform,and discard the washing.Rinse the stopper and the mouth of the separator with a few drops of water.Add 1.05g 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-mLsyringe,rapidly inject 0.5mLof 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 (7to 10minutes),releasing the pressure as necessary through the stopcock.Allow to stand for 5minutes,and extract the solution with five 10-mLportions of chloroform,filtering each extract through a pledget of cotton,previously washed with chloroform,into a tared 100-mLbeaker.Evaporate the combined chloroform extracts on a steam bath in a current of air or stream of nitrogen to dryness.Dry the residue at 80for 90minutes,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.
for 90minutes,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.
Auxiliary Information—
Staff Liaison:Lawrence Evans,III,Ph.D.,Scientist
Expert Committee:(PA6)Pharmaceutical Analysis 6
USP28–NF23Page 976
Phone Number:1-301-816-8389