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 90.0 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. 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.
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 the Assay for neomycin and the Assay for polymyxin B under Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Solution.
Assay preparation—
Transfer 3.0 mL of Otic Suspension, freshly mixed and free from air bubbles, 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.
in which C is the concentration, in mg per mL, of USP Hydrocortisone RS in the Standard preparation; and rU and rS are the peak responses obtained from the Assay preparation and the Standard preparation, respectively.
11
—
USP Hydrocortisone RS. USP Neomycin Sulfate RS. USP Polymyxin B Sulfate RS.