(sul bak' tam soe' dee um).
4-Thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid, 3,3-dimethyl-7-oxo-, 4,4-dioxide, sodium salt, (2S-cis)-.
Sodium (2S,5R)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate 4,4-dioxide [69388-84-7].
» Sulbactam Sodium contains not less than 886 µg and not more than 941 µg of sulbactam (C8H11NO5S) 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 11
USP Endotoxin RS
A: The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.
B: It meets the requirements of the tests for Sodium 191.
Crystallinity 695: meets the requirements.
Bacterial endotoxins 85 Where the label states that Sulbactam Sodium is sterile or must be subjected to further processing during the preparation of injectable dosage forms, it contains not more than 0.17 USP Endotoxin Unit per mg of sulbactam.
Sterility 71 Where the label states that Sulbactam Sodium is sterile, it meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined.
Water, Method I 921: not more than 1.0%.
0.005 M Tetrabutylammonium hydroxide Dilute 6.6 mL of a 40% solution of tetrabutylammonium hydroxide with water to obtain 1800 mL of solution. Adjust with 1 M phosphoric acid to a pH of 5.0 ± 0.1, dilute with water to 2000 mL, and mix.
Mobile phase Prepare a filtered and degassed mixture of 0.005 M Tetrabutylammonium hydroxide and acetonitrile (1650:350). Make adjustments if necessary (see System Suitability under Chromatography 621).
Standard preparation Quantitatively dissolve an accurately weighed quantity of USP Sulbactam RS in Mobile phase to obtain a solution having a known concentration of about 1 mg per mL. [noteInject this solution promptly. ]
Assay preparation Transfer about 110 mg of Sulbactam Sodium, accurately weighed, to a 100-mL volumetric flask, dissolve in and dilute with Mobile phase to volume, and mix. [noteInject this solution promptly. ]
Chromatographic system (see Chromatography 621)The liquid chromatograph is equipped with a 230-nm detector and a 4-mm × 30-cm column that contains packing L1. The flow rate is about 2 mL per minute. Chromatograph the Standard preparation, and record the responses as directed for Procedure: the column efficiency is not less than 3500 theoretical plates; the tailing factor is not more than 1.5; and the relative standard deviation for replicate injections is not more than 2.0%.
Procedure Separately inject equal volumes (about 10 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the areas for the major peaks. Calculate the quantity, in µg, of sulbactam (C8H11NO5S) in each mg of Sulbactam Sodium taken by the formula:
100(CP / W)(rU / rS)in which C is the concentration, in mg per mL, of USP Sulbactam RS in the Standard preparation; P is the assigned sulbactam content, in µg per mg, of USP Sulbactam RS; W is the quantity, in mg, of Sulbactam Sodium taken to prepare the Assay preparation; and rU and rS are the peak areas for sulbactam obtained from the Assay preparation and the Standard preparation, respectively.
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USP35NF30 Page 4699Pharmacopeial Forum: Volume No. 27(1) Page 1818