Ticarcillin and Clavulanic Acid Injection
» Ticarcillin and Clavulanic Acid Injection is a sterile isoosmotic solution of Ticarcillin Monosodium and Clavulanate Potassium in Water for Injection. It contains one or more suitable buffering agents and a tonicity-adjusting agent. It contains the equivalent of not less than 90.0 percent and not more than 115.0 percent of the labeled amount of ticarcillin (C15H16N2O6S2) and the equivalent of not less than 85.0 percent and not more than 120.0 percent of the labeled amount of clavulanic acid (C8H9NO5).
Packaging and storage— Preserve in Containers for Injections as described under Injections 1. Maintain in the frozen state.
Labeling— It meets the requirements for Labeling under Injections 1. The label states that it is to be thawed just prior to use, describes conditions for proper storage of the resultant solution, and directs that the solution is not to be refrozen.
Identification— The chromatogram of the Assay preparation obtained as directed in the Assay exhibits a major peak for ticarcillin, the retention time of which corresponds to that exhibited in the chromatogram of the Standard preparation obtained as directed in the Assay.
Bacterial endotoxins 85— It contains not more than 0.07 USP Endotoxin Unit per mg of ticarcillin.
Sterility 71— It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined.
pH 791: between 5.5 and 7.5.
Particulate matter 788: meets the requirements for small-volume injections.
Other requirements— It meets the requirements for Uniformity of Dosage Units 905 and for Labeling under Injections 1.
Assay—
pH 4.3 sodium phosphate buffer , Mobile phase, pH 6.4 phosphate buffer, Clavulanate lithium stock standard solution, Standard preparation, and Chromatographic system—Proceed as directed in the Assay under Ticarcillin and Clavulanic Acid for Injection.
Assay preparation— Allow a container of Injection to thaw, and mix the solution. Dilute an accurately measured volume of Injection quantitatively, and stepwise if necessary, with pH 6.4 phosphate buffer to obtain a solution having a concentration of about 0.9 mg of ticarcillin (C15H16N2O6S2) per mL.
Procedure— Proceed as directed for Procedure in the Assay under Ticarcillin and Clavulanic Acid for Injection. Calculate the quantity, in mg, of ticarcillin (C15H16N2O6S2) in each mL of the Injection taken by the formula:
(L / D)(CP / 1000)(rU / rS)
in which L is the labeled quantity, in mg per mL, of ticarcillin (C15H16N2O6S2) in the Injection; D is the concentration, in mg per mL, of ticarcillin in the Assay preparation, based on the labeled quantity and the extent of dilution; C is the concentration, in mg per mL, of USP Ticarcillin Monosodium Monohydrate RS in the Standard preparation; P is the designated potency, in µg of ticarcillin per mg, of USP Ticarcillin Monosodium Monohydrate RS; and rU and rS are the ticarcillin peak responses obtained from the Assay preparation and the Standard preparation, respectively.
Calculate the quantity, in mg, of clavulanic acid (C8H9NO5) in each mL of the Injection taken by the formula:
(L / D)(CP / 1000)(rU / rS)
in which L is the labeled quantity, in mg per mL, of clavulanic acid (C8H9NO5) in the Injection; D is the concentration, in mg per mL, of clavulanic acid in the Assay preparation, based on the labeled quantity and the extent of dilution; C is the concentration, in mg per mL, of USP Clavulanate Lithium RS in the Standard preparation; P is the designated potency, in µg of clavulanic acid per mg, of USP Clavulanate Lithium RS; and rU and rS are the clavulanic acid peak responses obtained from the Assay preparation and the Standard preparation, respectively.
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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
85 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
1-301-816-8339		 (MSA05) Microbiology and Sterility Assurance
71 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
1-301-816-8339		 (MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 3742