4-Thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid, 6-(carboxy-3-thienylacetyl)amino-3,3-dimethyl-7-oxo-, disodium salt, [2S-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].
» Ticarcillin Disodium has a potency equivalent to not less than 800 µg of ticarcillin (C15H16N2O6S2) per mg, calculated on the anhydrous basis.
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.
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.
Water, Method I 921: not more than 6.0%.
Dimethylaniline 223: meets the requirement.
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 (C15H16N2O6S2) 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.
Other requirements Where the label states that Ticarcillin Disodium is sterile, it meets the requirements for Sterility Tests 71 and for Bacterial endotoxins under Ticarcillin for Injection. Where the label states that Ticarcillin Disodium must be subjected to further processing during the preparation of injectable dosage forms, it meets the requirements for Bacterial endotoxins under Ticarcillin for Injection.
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 (C15H16N2O6S2) 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.
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USP32NF27 Page 3741