Neomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic Suspension
»Neomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic Suspension is a sterile,aqueous 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.
Packaging and storage— Preserve in tight 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 4.1and 7.0.
Assay for neomycin— Proceed as directed for neomycin underAntibiotics—Microbial Assays á81ñ,using an accurately measured volume of Ophthalmic Suspension,freshly mixed and free from air bubbles,diluted quantitatively and stepwise withBuffer No.3to yield aTest Dilution having a concentration assumed to be equal to the median dose level of the Standard.
Assay for polymyxin B— Proceed as directed for polymyxin BunderAntibiotics—Microbial Assays á81ñ,using an accurately measured volume of Ophthalmic Suspension,freshly mixed and free from air bubbles,diluted quantitatively and stepwise withBuffer No.6to yield aTest Dilution having a concentration assumed to be equal to the median dose level of the Standard.Add to each test dilution of the Standard a quantity of Neomycin Sulfate RS,dissolved inBuffer No.6,to yield the same concentration of neomycin as is present in theTest Dilution.
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 an accurately measured volume of Ophthalmic Suspension,freshly mixed and free from air bubbles,equivalent to about 30mg of hydrocortisone,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 Ophthalmic Suspension taken by the formula:
200(C/V)(rU/rS),
in whichCis the concentration,in mg per mL,of USP Hydrocortisone RSin theStandard preparation;Vis the volume,in mL,of Ophthalmic Suspension taken;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 1358
Phone Number:1-301-816-8335