U.S. PHARMACOPEIA

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Neomycin for Injection
» Neomycin for Injection contains an amount of Neomycin Sulfate equivalent to not less than 90.0 percent and not more than 120.0 percent of the labeled amount of neomycin.
Packaging and storage— Preserve in Containers for Sterile Solids as described under Injections 1.
Thin-layer chromatographic identification test 201BNP: meets the requirements.
Bacterial endotoxins 85— It contains not more than 1.30 USP Endotoxin Units per mg of neomycin.
Sterility 71— It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Other requirements— It meets the requirements for pH and Loss on drying under Neomycin Sulfate and for Uniformity of Dosage Units 905 and Labeling under Injections 1.
Assay—
Assay preparation 1 (where it is packaged for dispensing)—Constitute Neomycin for Injection as directed in the labeling. Withdraw all of the withdrawable contents, using a suitable hypodermic needle and syringe, and dilute quantitatively with Buffer No. 3 to obtain a solution having a convenient concentration.
Assay preparation 2 (where it is packaged for dispensing and where the labeling states the quantity of neomycin in a given volume of constituted solution)—Constitute Neomycin for Injection as directed in the labeling. Dilute an accurately measured volume of the constituted solution quantitatively with Buffer No. 3 to obtain a solution having a convenient concentration.
Procedure— Proceed as directed for neomycin under Antibiotics—Microbial Assays 81, using an accurately measured volume of Assay preparation 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.
Auxiliary Information— Staff Liaison : Brian D. Gilbert, Ph.D., Scientist
Expert Committee : (MDANT05) Monograph Development-Antibiotics
USP29–NF24 Page 1492
Pharmacopeial Forum : Volume No. 28(4) Page 1152
Phone Number : 1-301-816-8223