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.
Assay
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 (C
15H
16N
2O
6S
2) withdrawn from the container or in the volume of constituted solution taken by the formula: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 (C
15H
16N
2O
6S
2) 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.