Neomycin for Injection
»Neomycin for Injection contains an amount of Neomycin Sulfate equivalent to not less than 90.0percent and not more than 120.0percent of the labeled amount of neomycin.
Packaging and storage— Preserve in Containers for Sterile Solidsas described under Injections á1ñ.
Thin-layer chromatographic identification test á201BNPñ: meets the requirements.
Bacterial endotoxins á85ñ— It contains not more than 1.30USP Endotoxin Units per mg of neomycin.
Sterility á71ñ— It meets the requirements when tested as directed for Membrane Filtrationunder Test for Sterility of the Product to be Examined.
Other requirements— It meets the requirements for pHand Loss on dryingunder Neomycin Sulfateand for Uniformity of Dosage Units á905ñand Labelingunder Injections á1ñ.
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.3to 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.3to obtain a solution having a convenient concentration.
Procedure— Proceed as directed for neomycin under Antibiotics—Microbial Assays á81ñ,using an accurately measured volume of Assay preparationdiluted quantitatively and stepwise with Buffer No.3to yield a Test Dilution having a concentration assumed to be equal to the median dose level of the Standard.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1343
Pharmacopeial Forum:Volume No.28(4)Page 1152
Phone Number:1-301-816-8335