Benzocaine Ointment
»Benzocaine Ointment contains not less than 90.0percent and not more than 110.0percent of the labeled amount of C9H11NO2in a suitable ointment base.
Packaging and storage
Preserve in tight containers,protected from light,and avoid prolonged exposure to temperatures exceeding 30
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Identification
Ointments having water-soluble bases
Transfer an amount of Ointment,equivalent to about 5mg of benzocaine,to a small beaker,add 20mLof 0.5Nhydrochloric acid,warm gently to disperse the ointment,cool,and filter,if necessary.To 10mLof the filtrate add 5drops of a solution of sodium nitrite (1in 10)and 2drops of methyl red TS,and neutralize with 1Nsodium hydroxide.Add 2mLof a solution of 100mg of 2-naphthol in 5mLof sodium hydroxide TS:an orange-red precipitate is formed.
Ointments having water-insoluble bases
Transfer an amount of Ointment,equivalent to about 2.5mg of benzocaine,to a small separator,and dissolve in 20mLof ether.Extract with 10mLof 0.5Nhydrochloric acid,and filter the aqueous phase through paper into a small beaker.Add 5drops of a solution of sodium nitrite (1in 10)and 2drops of methyl red TS,and neutralize with 1Nsodium hydroxide.Add 2mLof a solution of 100mg of 2-naphthol in 5mLof 1Nsodium hydroxide:an orange-red precipitate is formed.
Microbial limits á61ñ
It meets the requirements of the tests for absence of Staphylococcus aureusand Pseudomonas aeruginosa.
Minimum fill á755ñ:
meets the requirements.
Assay
Ointments having water-soluble bases
Accurately weigh an amount of Ointment,equivalent to about 200mg of benzocaine,in a tared 250-mLbeaker.Add 50mLof water and 5mLof hydrochloric acid,and stir by mechanical means until solution is effected.Cool the solution in an ice bath to about 10
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Ointments having water-insoluble bases
Accurately weigh an amount of Ointment,equivalent to about 200mg of benzocaine,and transfer to a 125-mLseparator.Suspend the ointment in 50mLof ether by shaking,and extract with three successive 25-mLportions of 1Nhydrochloric acid,filtering each portion into a 250-mLbeaker,and proceed as directed under Ointments having water-soluble bases,beginning with Cool the solution.
Auxiliary Information
Staff Liaison:Karen A Russo,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28NF23Page 230
Phone Number:1-301-816-8379
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