Carbenicillin Disodium
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
.
191.
pH 791:
between 6.5 and 8.0, in a solution containing 10 mg of carbenicillin per mL.
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%.
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—
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 Antibiotics—Microbial 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.
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.
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
| Monograph | Ahalya Wise, M.S.
Scientist 1-301-816-8161 |
(MDANT05) Monograph Development-Antibiotics |
| Reference Standards | Lili Wang, Technical Services Scientist 1-301-816-8129 RSTech@usp.org |
USP32–NF27 Page 1788