Neomycin Sulfate and Hydrocortisone Otic Suspension
»Neomycin Sulfate and Hydrocortisone Otic Suspension is a sterile suspension containing not less than 90.0percent and not more than 130.0percent of the labeled amount of neomycin,and not less than 90.0percent and not more than 110.0percent of the labeled amount of hydrocortisone.It contains Acetic Acid,and may contain one or more suitable buffers,dispersants,and preservatives.
NOTE—Where Neomycin Sulfate and Hydrocortisone Otic Suspension is prescribed,without reference to the quantity of neomycin or hydrocortisone contained therein,a product containing 3.5mg of neomycin and 10mg of hydrocortisone per mLshall be dispensed.
Packaging and storage— Preserve in tight,light-resistant containers.
Sterility á71ñ: meets the requirements.
pHá791ñ: between 4.5and 6.0.
Assay for neomycin— Using an accurately measured volume of Otic Suspension,freshly mixed and free from entrapped air,proceed as directed in the Assay for neomycinunder Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Solution.
Assay for hydrocortisone—
Assay preparation— Transfer 3.0mLof Otic Suspension,freshly mixed and free from entrapped air,to a 200-mLvolumetric flask,dilute with a mixture of methanol and water (1:1)to volume,and mix.Filter the solution,rejecting the first 10mLof the filtrate.
Procedure— Proceed as directed for Procedurein the Assay for hydrocortisone contentunder Neomycin and Polymyxin B Sulfates,Bacitracin Zinc,and Hydrocortisone Ophthalmic Ointment.Calculate the quantity,in mg,of C21H30O5in each mLof the Otic Suspension taken by the formula:
(66.67C)(rU/rS),
in which Cis the concentration,in mg per mL,of USP Hydrocortisone RSin the Standard preparation,and rUand rSare the peak responses obtained from the Assay preparationand the Standard preparation,respectively.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1348
Phone Number:1-301-816-8335
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