Ticarcillin for Injection, chemical structure, molecular formula, Reference Standards
Ticarcillin for Injection
»Ticarcillin for Injection contains an amount of Ticarcillin Disodium equivalent to not less than 90.0percent and not more than 115.0percent of the labeled amount of ticarcillin (C15H16N2O6S2).
Packaging and storage
Preserve in Containers for Sterile Solidsas described under Injections á1ñ.
USP Reference standards á11ñ
USP Endotoxin RS.USP Ticarcillin Monosodium Monohydrate RS.
At the time of use,it meets the requirements for Constituted Solutionsunder Injections á1ñ.
Bacterial endotoxins á85ñ
It contains not more than 0.05USP Endotoxin Unit per mg of ticarcillin.
It meets the requirements when tested as directed for Membrane Filtrationunder Test for Sterility of the Product to be Examined.
between 6.0and 8.0,in the solution constituted as directed in the labeling.
not more than 6.0%.
Particulate matter á788ñ:
meets the requirements for small-volume injections.
It responds to the Identificationtests and meets the requirements for Waterand Dimethylanilineunder Ticarcillin Disodium.It meets also the requirements for Uniformity of Dosage Units á905ñand Labelingunder Injections á1ñ.Ticarcillin for Injection that contains no added substances meets also the requirements for Specific rotationand Ticarcillin contentunder Ticarcillin Disodium.
pH4.3sodium phosphate buffer,Mobile phase,pH6.4sodium phosphate buffer,Standard preparation,Resolution solution,and Chromatographic system
Proceed as directed in the Assayunder Ticarcillin Monosodium.
Assay preparation 1
(where it is represented as being in a single-dose container)Constitute Ticarcillin for Injection as directed in the labeling.Withdraw all of the withdrawable contents,and dilute quantitatively with pH6.4sodium phosphate bufferto obtain a solution having a concentration of about 0.9mg of ticarcillin (C15H16N2O6S2)per mL.
Assay preparation 2
(where the label states the quantity of ticarcillin in a given volume of constituted solution)Constitute Ticarcillin for Injection as directed in the labeling.Dilute an accurately measured volume of the constituted solution quantitatively with pH6.4sodium phosphate bufferto obtain a solution having a concentration of about 0.9mg of ticarcillin (C15H16N2O6S2)per mL.
Proceed as directed for Procedurein the Assayunder Ticarcillin Monosodium.Calculate the quantity,in mg,of ticarcillin (C15H16N2O6S2)withdrawn from the container or in the volume of constituted solution taken by the formula:
in which Lis the labeled quantity,in mg per mL,of ticarcillin (C15H16N2O6S2)in the container or in the volume of constituted solution taken;Dis the concentration,in mg per mL,of ticarcillin in Assay preparation 1or Assay preparation 2,based on the labeled quantity in the container or in the portion of constituted solution taken,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.
Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
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