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 90.0 percent and not more than 130.0 percent of the labeled amounts of neomycin and of polymyxin B. It contains not less than 90.0 percent and not more than 110.0 percent 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.
USP Reference standards 11
USP Hydrocortisone RS. USP Neomycin Sulfate RS. USP Polymyxin B Sulfate RS.
Thin-layer chromatographic identification test 201BNP:
meets the requirements.
Sterility 71:
meets the requirements.
pH 791:
between 4.1 and 7.0.
Assay for neomycin
Proceed as directed for neomycin under AntibioticsMicrobial 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 AntibioticsMicrobial 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 yield the same concentration of neomycin as is present in the Test Dilution.
Assay for hydrocortisone
Mobile phase, Standard preparation, and Chromatographic system
Prepare as directed in the Assay for hydrocortisone under Neomycin 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 30 mg of hydrocortisone, to a 200-mL volumetric flask, dilute with a mixture of methanol and water (1:1) to volume, and mix. Filter the solution, rejecting the first 10 mL of the filtrate.
Procedure
Proceed as directed for Procedure in the Assay for hydrocortisone under Neomycin and Polymyxin B Sulfates, Bacitracin Zinc and Hydrocortisone Ophthalmic Ointment. Calculate the quantity, in mg, of C21H30O5 in each mL of the Ophthalmic Suspension taken by the formula:
200(C/V)(rU / rS)
in which C is the concentration, in mg per mL, of USP Hydrocortisone RS in the Standard preparation; V is the volume, in mL, of Ophthalmic Suspension taken; and rU and rS are the peak responses obtained from the Assay preparation and the Standard preparation, respectively.
Auxiliary Information
Please check for your question in the FAQs before contacting USP.
Chromatographic Column
USP32NF27 Page 3063
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.
|