Carbenicillin for Injection
»Carbenicillin for Injection contains an amount of Carbenicillin Disodium equivalent to not less than 90.0percent and not more than 120.0percent of the labeled amount of carbenicillin (C17H18N2O6S).
Packaging and storage— Preserve in Containers for Sterile Solidsas described under Injections á1ñ.
Identification— It responds to the tests for Sodium á191ñ.
Bacterial endotoxins á85ñ— It contains not more than 0.05USP Endotoxin Unit per mg of carbenicillin.
Sterility á71ñ— It meets the requirements when tested as directed for Membrane Filtrationunder Test for Sterility of the Product to be Examined,6g being aseptically dissolved in 200mLof Fluid A.
pHá791ñ: between 6.5and 8.0,in the solution constituted as directed in the labeling.
Water,Method Iá921ñ: not more than 6.0%.
Particulate matter á788ñ: meets the requirements for small-volume injections.
Other requirements— It meets the requirements for Uniformity of Dosage Units á905ñand Constituted Solutionsand Labelingunder Injections á1ñ.
Assay—
Assay preparation 1 (where it is packaged for dispensing and where the package is represented as being a single-dose container)—Constitute Carbenicillin for Injection as directed in the labeling.Withdraw all of the withdrawable contents,and dilute quantitatively with Buffer No.1to obtain a solution having a convenient concentration of carbenicillin.
Assay preparation 2 (where the label states the quantity of carbenicillin in a given volume of constituted solution)—Constitute Carbenicillin for Injection as directed in the labeling.Dilute an accurately measured volume of the constituted solution quantitatively with Buffer No.1to obtain a solution having a convenient concentration of carbenicillin.
Procedure— Proceed as directed under Antibiotics—Microbial Assays á81ñ,using an accurately measured volume of Assay preparationdiluted quantitatively with Buffer No.1to yield a Test Dilutionhaving 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 345
Phone Number:1-301-816-8335