Ticarcillin for Injection
» Ticarcillin for Injection contains an amount of Ticarcillin Disodium equivalent to not less than 90.0 percent and not more than 115.0 percent of the labeled amount of ticarcillin (C15H16N2O6S2).
Packaging and storage Preserve in Containers for Sterile Solids as described under Injections 1.
Constituted solution At the time of use, it meets the requirements for Constituted Solutions under Injections 1.
Bacterial endotoxins 85 It contains not more than 0.05 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 6.0 and 8.0, in the solution constituted as directed in the labeling.
Water, Method I 921: not more than 6.0%.
Particulate matter 788: meets the requirements for small-volume injections.
Other requirements It responds to the Identification tests and meets the requirements for Water and Dimethylaniline under Ticarcillin Disodium. It meets also the requirements for Uniformity of Dosage Units 905 and Labeling under Injections 1. Ticarcillin for Injection that contains no added substances meets also the requirements for Specific rotation and Ticarcillin content under Ticarcillin Disodium.
pH 4.3 sodium phosphate buffer, Mobile phase, pH 6.4 sodium phosphate buffer, Standard preparation, Resolution solution, and Chromatographic system Proceed as directed in the Assay under 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 pH 6.4 sodium phosphate buffer to obtain a solution having a concentration of about 0.9 mg 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 pH 6.4 sodium 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 Monosodium. Calculate the quantity, in mg, of ticarcillin (C15H16N2O6S2) withdrawn from the container or in the volume of constituted solution taken by the formula: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 container or in the volume of constituted solution taken; D is the concentration, in mg per mL, of ticarcillin in Assay preparation 1 or Assay preparation 2, based on the labeled quantity in the container or in the portion of constituted solution taken, 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.
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USP32NF27 Page 3741