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 90.0percent and not more than 115.0percent of the labeled amount of ticarcillin (C15H16N2O6S2)and the equivalent of not less than 85.0percent and not more than 120.0percent of the labeled amount of clavulanic acid (C8H9NO5).
Packaging and storage— Preserve in Containers for Injectionsas described under Injections á1ñ.Maintain in the frozen state.
Labeling— It meets the requirements for Labelingunder Injections á1ñ.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 preparationobtained as directed in the Assayexhibits a major peak for ticarcillin,the retention time of which corresponds to that exhibited in the chromatogram of the Standard preparationobtained as directed in the Assay.
Bacterial endotoxins á85ñ— It contains not more than 0.07USP Endotoxin Unit per mg of ticarcillin.
Sterility á71ñ— It meets the requirements when tested as directed for Membrane Filtrationunder Test for Sterility of the Product to be Examined.
pHá791ñ: between 5.5and 7.5.
Particulate matter á788ñ: meets the requirements for small-volume injections.
Other requirements— It meets the requirements for Uniformity of Dosage Units á905ñand for Labelingunder Injections á1ñ.
Assay—
pH4.3sodium phosphate buffer ,Mobile phase,pH6.4phosphate buffer,Clavulanate lithium stock standard solution,Standard preparation,and Chromatographic system—Proceed as directed in the Assayunder 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 pH6.4phosphate bufferto obtain a solution having a concentration of about 0.9mg of ticarcillin (C15H16N2O6S2)per mL.
Procedure— Proceed as directed for Procedurein the Assayunder Ticarcillin and Clavulanic Acid for Injection.Calculate the quantity,in mg,of ticarcillin (C15H16N2O6S2)in each mLof the Injection taken by the formula:
(L/D)(CP/1000)(rU/rS),
in which Lis the labeled quantity,in mg per mL,of ticarcillin (C15H16N2O6S2)in the Injection;Dis the concentration,in mg per mL,of ticarcillin in the Assay preparation,based on the labeled quantity and the extent of dilution;Cis the concentration,in mg per mL,of USP Ticarcillin Monosodium Monohydrate RSin the Standard preparation;Pis the designated potency,in µg of ticarcillin per mg,of USP Ticarcillin Monosodium Monohydrate RS;and rUand rSare the ticarcillin peak responses obtained from the Assay preparationand the Standard preparation,respectively.
Calculate the quantity,in mg,of clavulanic acid (C8H9NO5)in each mLof the Injection taken by the formula:
(L/D)(CP/1000)(rU/rS),
in which Lis the labeled quantity,in mg per mL,of clavulanic acid (C8H9NO5)in the Injection;Dis the concentration,in mg per mL,of clavulanic acid in the Assay preparation,based on the labeled quantity and the extent of dilution;Cis the concentration,in mg per mL,of USP Clavulanate Lithium RSin the Standard preparation;Pis the designated potency,in µg of clavulanic acid per mg,of USP Clavulanate Lithium RS;and rUand rSare the clavulanic acid peak responses obtained from the Assay preparationand the Standard preparation,respectively.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1928
Phone Number:1-301-816-8335