Neomycin for Injection
If you find any inaccurate information, please let us know by providing your feedback here
This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
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.
1 Packaging and storage
Preserve as described in Packaging and Storage Requirements 〈659〉, Injection Packaging, Packaging for constitution.
1.1 USP Reference standards 〈11〉
USP Neomycin Sulfate RS
Thin-layer chromatographic identification test 〈201BNP〉: meets the requirements.
Bacterial Endotoxins Test 〈85〉 - It contains not more than 1.30 USP Endotoxin Units per mg of neomycin.
Sterility Tests 〈71〉 - It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined.
2 Other requirements
It meets the requirements for pH and Loss on drying under Neomycin Sulfate and for Uniformity of Dosage Units 〈905〉 and Labeling 〈7〉, Labels and Labeling for Injectable Products.
3 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 B.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 B.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 B.3 to yield a Test Dilution having a concentration assumed to be equal to the median dose level of the Standard.
