U.S. PHARMACOPEIA

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Neomycin and Polymyxin B Sulfates Solution for Irrigation
» Neomycin and Polymyxin B Sulfates Solution for Irrigation is a sterile, aqueous solution 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 may contain a suitable preservative.
Packaging and storage— Preserve in tight containers.
Labeling— Label it to indicate that it is to be diluted for use in a urinary bladder irrigation and is not intended for injection.
Thin-layer chromatographic identification test 201BNP: meets the requirements.
Sterility 71— It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined.
pH 791: between 4.5 and 6.0.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay for neomycin and Assay for polymyxin B— Proceed with Neomycin and Polymyxin B Sulfates Solution for Irrigation as directed in the Assay for neomycin and in the Assay for polymyxin B under Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Solution.
Auxiliary Information— Staff Liaison : Brian D. Gilbert, Ph.D., Scientist
Expert Committee : (MDANT05) Monograph Development-Antibiotics
USP29–NF24 Page 1502
Pharmacopeial Forum : Volume No. 28(4) Page 1159
Phone Number : 1-301-816-8223