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 90.0 percent and not more than 125.0 percent of the labeled amounts of neomycin and polymyxin B, and not less than 90.0 percent and not more than 110.0 percent 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 preparation obtained as directed in the Assay for prednisolone acetate exhibits a major peak for prednisolone acetate, the retention time of which corresponds to that exhibited in the chromatogram of the Standard preparation obtained as directed in the Assay for prednisolone acetate.
Sterility 71: meets the requirements.
pH 791: between 5.0 and 7.0.
Assay for neomycin— Proceed as directed for neomycin under Antibiotics—Microbial Assays 81, using an accurately measured volume of Ophthalmic Suspension, freshly mixed and free from air bubbles, diluted quantitatively and stepwise with Buffer No. 3 to yield a Test 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 B under Antibiotics—Microbial Assays 81, using an accurately measured volume of Ophthalmic Suspension, freshly mixed and free from air bubbles, diluted quantitatively and stepwise with Buffer No. 6 to yield a Test 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 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 acetate under 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 2.5 mg of prednisolone acetate, to a suitable container, add 5.0 mL of Internal standard solution and about 100 mL of water-saturated chloroform, and shake by mechanical means for about 15 minutes. Allow to separate for about 15 minutes, and use the clear chloroform layer as the Assay preparation.
Procedure— Proceed as directed in the Assay for prednisolone acetate under Neomycin Sulfate and Prednisolone Acetate Ophthalmic Suspension. Calculate the quantity, in mg, of prednisolone acetate (C23H30O6) in each mL of the Ophthalmic Suspension taken by the formula:
0.1(C / V)(RU / RS)
in which C is the concentration, in µg per mL, of USP Prednisolone Acetate RS in the Standard preparation, V is the volume, in mL, of Ophthalmic Suspension taken, and RU and RS are the peak response ratios of prednisolone acetate to betamethasone obtained from the Assay preparation and the Standard preparation, respectively.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Ahalya Wise, M.S.
Scientist
1-301-816-8161		 (MDANT05) Monograph Development-Antibiotics
Reference Standards Lili Wang, Technical Services Scientist
1-301-816-8129
RSTech@usp.org
71 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
1-301-816-8339		 (MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 3066
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.