5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 3-[[(5-methyl-1,3,4-thiadiazol-2-yl)thio]methyl]-8-oxo-7-[[(1H-tetrazol-1-yl)acetyl]amino]-, monosodium salt (6R-trans).
Monosodium (6R,7R)-3-[[(5-methyl-1,3,4-thiadiazol-2-yl)thio]methyl]-8-oxo-7-[2-(1H-tetrazol-1-yl)acetamido]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate [27164-46-1].
» Cefazolin Sodium has a potency equivalent to not less than 89.1 percent and not more than 110.1 percent of cefazolin sodium (C14H13NaN8O4S3), 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.
Medium: 0.1 M sodium bicarbonate.
B: The retention time of the major peak for cefazolin in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.
C: It responds to the tests for Sodium 191.
Specific rotation 781S: between 10 and 24.
Test solution: 55 mg per mL, in 0.1 M sodium bicarbonate.
pH 791: between 4.0 and 6.0, in a solution containing 100 mg of cefazolin per mL.
Water, Method I 921: not more than 6.0%.
Other requirements Where the label states that Cefazolin Sodium is sterile, it meets the requirements for Sterility and Bacterial endotoxins under Cefazolin for Injection. Where the label states that Cefazolin Sodium must be subjected to further processing during the preparation of injectable dosage forms, it meets the requirements for Bacterial endotoxins under Cefazolin for Injection.
pH 3.6 Buffer, pH 7.0 Buffer, Mobile phase, Internal standard solution, Standard preparation, and Chromatographic system Prepare as directed in the Assay under Cefazolin.
Assay preparation Transfer about 50 mg of Cefazolin Sodium, accurately weighed, to a 50-mL volumetric flask, dissolve in and dilute with pH 7.0 Buffer to volume, and mix. Transfer 5.0 mL of this solution to a 100-mL volumetric flask, add 5.0 mL of Internal standard solution, dilute with pH 7.0 Buffer to volume, and mix.
Procedure Proceed as directed for Procedure in the Assay under Cefazolin. Calculate the quantity, in mg, of cefazolin sodium (C14H13NaN8O4S3) in the portion of Cefazolin Sodium taken to prepare the Assay preparation by the formula:
(476.49 / 454.51)(1000C)(RU / RS)in which 476.49 and 454.51 are the molecular weights of cefazolin sodium and cefazolin, respectively; C is the concentration, in mg per mL, of USP Cefazolin RS in the Standard preparation, calculated on the anhydrous basis; and the other terms are as defined therein.
Auxiliary Information Please check for your question in the FAQs before contacting USP.Chromatographic Column
USP32NF27 Page 1823Pharmacopeial Forum: Volume No. 34(6) Page 1438
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.