C₁₅H₁₄N₂Na₂O₆S₂ 428.40
4-Thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid,6-(carboxy-3-thienylacetyl)amino-3,3-dimethyl-7-oxo-,disodium salt,[2S-2a,5a,6b(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 800μg 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.

USP Reference standards á11? — USP Endotoxin RS .USP Ticarcillin Monosodium Monohydrate RS .

Identification—

A: Ultraviolet Absorption á197U? —

Solution: 20μg per mL.Use the solution prepared as directed in the test for Ticarcillin content ,recording the spectrum between 200and 300nm.

B: Asolution (1in 20)responds to the tests for Sodium á191?.

Specific rotation á781S?: between +172

Test solution: 10mg per mL,in water.

pHá791? : between 6.0and 8.0,in a solution containing 10mg of ticarcillin per mL.

Water,Method Iá921? : not more than 6.0%.

Dimethylaniline á223? : meets the requirement.

Ticarcillin content— Transfer about 40mg,accurately weighed,to a 100-mLvolumetric flask,dissolve in and dilute with water to volume,and mix.Transfer 5.0mLof this solution to another 100-mLvolumetric flask,dilute with 0.1Nmethanolic hydrochloric acid (0.8mLof hydrochloric acid diluted with methanol to 100mL)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 230nm,using a reagent blank.Calculate the percentage of ticarcillin (C₁₅H₁₆N₂O₆S₂)taken by the formula:

P(W_S/W_U)(A_U/A_S),

in which Pis the percentage content of ticarcillin in USP Ticarcillin Monosodium Monohydrate RS ;W_Sand W_Uare the amounts of USP Ticarcillin Monosodium Monohydrate RS and Ticarcillin Disodium taken,respectively;and A_Uand A_Sare 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 á71? 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 .

Assay—

pH4.3sodium phosphate buffer,Mobile phase,pH6.4sodium phosphate buffer,Standard preparation,Resolution solution,and Chromatographic system— Proceed as directed in the Assayunder Ticarcillin Monosodium.

Assay preparation— Transfer about 50mg of Ticarcillin Disodium,accurately weighed,to a 50-mLvolumetric flask,add pH6.4sodium phosphate bufferto volume,and mix.

Procedure— Proceed as directed for Procedurein the Assayunder Ticarcillin Monosodium.Calculate the quantity,in μg,of ticarcillin (C₁₅H₁₆N₂O₆S₂)per mg of the Ticarcillin Disodium taken by the formula:

50(CP/M)(r_U/r_S),

in which Cis the concentration,in mg per mL,of USP Ticarcillin Monosodium Monohydrate RS in the Standard preparation;Pis the designated potency,in μg of ticarcillin per mg,of USP Ticarcillin Monosodium Monohydrate RS ;Mis the quantity,in mg,of Ticarcillin Disodium taken to prepare the Assay preparation;and r_Uand r_Sare the ticarcillin peak responses obtained from the Assay preparationand the Standard preparation,respectively.