Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension
»Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension is a sterile suspension containing the equivalent of not less than 90.0percent and not more than 130.0percent of the labeled amounts of neomycin and of polymyxin B.It contains not less than 90.0percent and not more than 110.0percent of the labeled amount of hydrocortisone.It may contain one or more suitable buffers,dispersants,and preservatives.
Packaging and storage— Preserve in tight,light-resistant containers.The containers or individual cartons are sealed and tamper-proof so that sterility is assured at time of first use.
Thin-layer chromatographic identification test á201BNPñ: meets the requirements.
Sterility á71ñ: meets the requirements.
pHá791ñ: between 3.0and 7.0.
Assay for neomycin and Assay for polymyxin B— Using an accurately measured volume of Otic Suspension,freshly mixed and free from air bubbles,proceed as directed in theAssay for neomycin and theAssay for polymyxin BunderNeomycin and Polymyxin B Sulfates and Hydrocortisone Otic Solution.
Assay for hydrocortisone—
Mobile phase,Standard preparation,and Chromatographic system— Prepare as directed in theAssay for hydrocortisone underNeomycin and Polymyxin B Sulfates,Bacitracin Zinc and Hydrocortisone Ophthalmic Ointment.
Assay preparation— Transfer 3.0mLof Otic Suspension,freshly mixed and free from air bubbles,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 forProcedure in theAssay for hydrocortisone underNeomycin 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 whichCis the concentration,in mg per mL,of USP Hydrocortisone RSin theStandard preparation;andrUandrSare the peak responses obtained from theAssay preparation and theStandard preparation,respectively.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1359
Phone Number:1-301-816-8335