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.
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 (C
15H
16N
2O
6S
2) 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 (C
15H
16N
2O
6S
2) 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 (C
8H
9NO
5) 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.
