Cefazolin Sodium
C14H13N8NaO4S3
476.49
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 89.1percent and not more than 110.1percent 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.
Identification—
Solution:
20µg per mL.
Medium:
0.1Msodium bicarbonate.
B:
The retention time of the major peak for cefazolin in the chromatogram of the Assay preparationcorresponds to that in the chromatogram of the Standard preparation,as obtained in the Assay.
C:
It responds to the tests for Sodium á191ñ.
Specific rotation á781Sñ:
between -10
and -24.
and -24.
Test solution:
55mg per mL,in 0.1Msodium bicarbonate.
pHá791ñ:
between 4.0and 6.0,in a solution containing 100mg of cefazolin per mL.
Water,Method Iá921ñ:
not more than 6.0%.
Other requirements—
Where the label states that Cefazolin Sodium is sterile,it meets the requirements for Sterilityand Bacterial endotoxinsunder 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 endotoxinsunder Cefazolin for Injection.
Assay—
pH3.6buffer,pH7.0buffer,Mobile phase,Internal standard solution,Standard preparation,and Chromatographic system—
Prepare as directed in the Assayunder Cefazolin.
Assay preparation—
Transfer about 50mg of Cefazolin Sodium,accurately weighed,to a 50-mLvolumetric flask,dissolve in and dilute with pH7.0bufferto volume,and mix.Transfer 5.0mLof this solution to a 100-mLvolumetric flask,add 5.0mLof Internal standard solution,dilute with pH7.0bufferto volume,and mix.
Procedure—
Proceed as directed for Procedurein the Assayunder Cefazolin.Calculate the quantity,in mg,of cefazolin sodium (C14H13NaN8O4S3)in the portion of Cefazolin Sodium taken to prepare the Assay preparationby the formula:
(476.49/454.51)(1000C)(RU/RS),
in which 476.49and 454.51are the molecular weights of cefazolin sodium and cefazolin,respectively,Cis the concentration,in mg per mL,of USP Cefazolin RSin the Standard preparation,calculated on the anhydrous basis,and the other terms are as defined therein.
Auxiliary Information—
Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 375
Pharmacopeial Forum:Volume No.26(6)Page 1539
Phone Number:1-301-816-8335