Neomycin and Polymyxin B Sulfates and Prednisolone Acetate Ophthalmic Suspension
»Neomycin and Polymyxin B Sulfates and Prednisolone Acetate Ophthalmic Suspension is a sterile suspension of Prednisolone Acetate in an aqueous solution of Neomycin Sulfate and Polymyxin B Sulfate.It contains the equivalent of not less than 90.0percent and not more than 125.0percent of the labeled amounts of neomycin and polymyxin B,and not less than 90.0percent and not more than 110.0percent of the labeled amount of prednisolone acetate (C23H30O6).It may contain suitable buffers,preservatives,and suspending agents.
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.
Identification— The chromatogram of the Assay preparationobtained as directed in the Assay for prednisolone acetateexhibits a major peak for prednisolone acetate,the retention time of which corresponds to that exhibited in the chromatogram of the Standard preparationobtained as directed in the Assay for prednisolone acetate.
Sterility á71ñ: meets the requirements.
pHá791ñ: between 5.0and 7.0.
Assay for neomycin— Proceed as directed for neomycin under Antibiotics—Microbial Assays á81ñ,using an accurately measured volume of Ophthalmic Suspension,freshly mixed and free from air bubbles,diluted quantitatively and stepwise with Buffer No.3to yield a Test Dilutionhaving a concentration assumed to be equal to the median dose level of the Standard.
Assay for polymyxin B— Proceed as directed for polymyxin Bunder Antibiotics—Microbial Assays á81ñ,using an accurately measured volume of Ophthalmic Suspension,freshly mixed and free from air bubbles,diluted quantitatively and stepwise with Buffer No.6to yield a Test Dilutionhaving 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 in Buffer No.6,to obtain the same concentration of neomycin as is present in the Test Dilution.
Assay for prednisolone acetate—
Mobile phase ,Internal standard solution,Standard preparation,and Chromatographic system—Prepare as directed in the Assay for prednisolone acetateunder Neomycin Sulfate and Prednisolone Acetate Ophthalmic Suspension.
Assay preparation— Transfer an accurately measured volume of Ophthalmic Suspension,freshly mixed and free from air bubbles,equivalent to about 2.5mg of prednisolone acetate,to a suitable container,add 5.0mLof Internal standard solutionand about 100mLof water-saturated chloroform,and shake by mechanical means for about 15minutes.Allow to separate for about 15minutes,and use the clear chloroform layer as the Assay preparation.
Procedure— Proceed as directed in the Assay for prednisolone acetateunder Neomycin Sulfate and Prednisolone Acetate Ophthalmic Suspension.Calculate the quantity,in mg,of prednisolone acetate (C23H30O6)in each mLof the Ophthalmic Suspension taken by the formula:
0.1(C/V)(RU/RS),
in which Cis the concentration,in µg per mL,of USP Prednisolone Acetate RSin the Standard preparation,Vis the volume,in mL,of Ophthalmic Suspension taken,and RUand RSare the peak response ratios of prednisolone acetate to betamethasone 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 1361
Phone Number:1-301-816-8335