4-Thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid, 6-(carboxy-3-thienylacetyl)amino-3,3-dimethyl-7-oxo-, disodium salt, [2
S-2
,5
,6
(
S*)]-.
N-(2-Carboxy-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]-hept- 6-yl)-3-thiophenemalonamic acid disodium salt
[
4697-14-7].
Packaging and storage—
Preserve in tight containers.
Labeling—
Where it is intended for use in preparing injectable dosage forms, the label states that it is sterile or must be subjected to further processing during the preparation of injectable dosage forms.
Identification—
Solution:
20 µg per mL. Use the solution prepared as directed in the test for
Ticarcillin content, recording the spectrum between 200 and 300 nm.
B:
A solution (1 in 20) responds to the tests for
Sodium 
191
.
Specific rotation 781S:
between +172
and +187
.
Test solution:
10 mg per mL, in water.
pH 791:
between 6.0 and 8.0, in a solution containing 10 mg of ticarcillin per mL.
Ticarcillin content—
Transfer about 40 mg, accurately weighed, to a 100-mL volumetric flask, dissolve in and dilute with water to volume, and mix. Transfer 5.0 mL of this solution to another 100-mL volumetric flask, dilute with 0.1 N methanolic hydrochloric acid (0.8 mL of hydrochloric acid diluted with methanol to 100 mL) to volume, and mix. Concomitantly determine the absorbances of this test solution with a similarly prepared Standard solution of
USP Ticarcillin Monosodium Monohydrate RS, at the wavelength of maximum absorbance at about 230 nm, using a reagent blank. Calculate the percentage of ticarcillin (C
15H
16N
2O
6S
2) taken by the formula:
P(WS / WU)(AU / AS),
in which
P is the percentage content of ticarcillin in
USP Ticarcillin Monosodium Monohydrate RS;
WS and
WU are the amounts of
USP Ticarcillin Monosodium Monohydrate RS and Ticarcillin Disodium taken, respectively; and
AU and
AS are the absorbances of the test solution and the Standard solution, respectively: between 80.0% and 94.0%, calculated on the anhydrous basis, is found.
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—
Transfer about 50 mg of Ticarcillin Disodium, accurately weighed, to a 50-mL volumetric flask, add pH 6.4 sodium phosphate buffer to volume, and mix.
Procedure—
Proceed as directed for
Procedure in the
Assay under
Ticarcillin Monosodium. Calculate the quantity, in µg, of ticarcillin (C
15H
16N
2O
6S
2) per mg of the Ticarcillin Disodium taken by the formula:
50(CP / M)(rU / rS),
in which
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;
M is the quantity, in mg, of Ticarcillin Disodium taken to prepare the
Assay preparation; and
rU and
rS are the ticarcillin peak responses obtained from the
Assay preparation and the
Standard preparation, respectively.
;)
Ultraviolet Absorption