4-Thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid, 6-[(carboxyphenylacetyl)amino]-3,3-dimethyl-7-oxo-, disodium salt, [2S-(2,5,6)]-.
N-(2-Carboxy-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo.[3.2.0]- hept-6-yl)- 2-phenylmalonamic acid disodium salt [4800-94-6].
» Carbenicillin Disodium has a potency equivalent to not less than 770 µg of carbenicillin (C17H18N2O6S) per mg, calculated on the anhydrous basis.
Packaging and storage Preserve in tight containers.
Labeling Where it is intended for use in preparing injectable dosage forms, the label states that it is sterile or must be subjected to further processing during the preparation of injectable dosage forms.
Identification It responds to the tests for Sodium 191.
pH 791: between 6.5 and 8.0, in a solution containing 10 mg of carbenicillin per mL.
Water, Method I 921: not more than 6.0%.
Other requirements Where the label states that Carbenicillin Disodium is sterile, it meets the requirements for Sterility and Bacterial endotoxins under Carbenicillin for Injection. Where the label states that Carbenicillin Disodium must be subjected to further processing during the preparation of injectable dosage forms, it meets the requirements for Bacterial endotoxins under Carbenicillin for Injection.
Assay preparation Dissolve a suitable quantity of Carbenicillin Disodium, accurately weighed, in Buffer No. 1, and dilute 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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USP32NF27 Page 1788