Carbenicillin for Injection
» Carbenicillin for Injection contains an amount of Carbenicillin Disodium equivalent to not less than 90.0 percent and not more than 120.0 percent of the labeled amount of carbenicillin (C17H18N2O6S).
Packaging and storage Preserve in Containers for Sterile Solids as described under Injections 1.
USP Reference standards 11
USP Carbenicillin Monosodium Monohydrate RS
USP Endotoxin RS
Identification It responds to the tests for Sodium 191.
Bacterial endotoxins 85 It contains not more than 0.05 USP Endotoxin Unit per mg of carbenicillin.
Sterility 71 It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined, 6 g being aseptically dissolved in 200 mL of Fluid A.
pH 791: between 6.5 and 8.0, in the solution constituted as directed in the labeling.
Water, Method I 921: not more than 6.0%.
Particulate matter 788: meets the requirements for small-volume injections.
Other requirements It meets the requirements for Uniformity of Dosage Units 905 and Constituted Solutions and Labeling under Injections 1.
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. 1 to 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. 1 to obtain a solution having a convenient concentration of carbenicillin.
Procedure Proceed as directed under AntibioticsMicrobial Assays 81, using an accurately measured volume of Assay preparation diluted quantitatively with Buffer No. 1 to yield a Test Dilution having a concentration assumed to be equal to the median dose level of the Standard.
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USP35NF30 Page 2486