Cefazolin for Injection
»Cefazolin for Injection contains an amount of Cefazolin Sodium equivalent to not less than 90.0percent and not more than 115.0percent of the labeled amount of cefazolin (C14H14N8O4S3).
Packaging and storage— Preserve in Containers for Injectionsas described under Injections á1ñ.
Constituted solution— At the time of use,it meets the requirements for Constituted Solutionsunder Injections á1ñ.
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 meets the requirements of the tests for Sodium á191ñ.
Specific rotation á781Sñ: between -10and -24.
Test solution: 55mg per mL,in 0.1Msodium bicarbonate.
Bacterial endotoxins á85ñ It contains not more than 0.15USP Endotoxin Unit per mg of cefazolin.
Sterility á71ñ It meets the requirements when tested as directed for Membrane Filtrationunder Test for Sterility of the Product to be Examined.
Uniformity of dosage units á905ñ: meets the requirements.
Procedure for content uniformity— Perform the Assayon individual containers using Assay preparation 1or Assay preparation 2,or both,as appropriate.
pHá791ñ: between 4.0and 6.0,in a solution containing 100mg of cefazolin per mL.
Water,Method Iá921ñ: not more than 6.0%.
Particulate matter á788ñ: meets the requirements for small-volume injections.
Other requirements— It meets the requirements for Labelingunder Injections á1ñ.
Assay—
pH3.6buffer,pH7.0buffer,Mobile phase,Internal standard solution,Standard preparation,and Chromatographic system Prepare as directed in the Assayunder Cefazolin.
Assay preparation 1 (where it is packaged for dispensing and is represented as being in a single-dose container)—Constitute Cefazolin for Injection in a volume of water,accurately measured,corresponding to the volume of solvent specified in the labeling.Withdraw all of the withdrawable contents,using a suitable hypodermic needle and syringe,and dilute quantitatively with pH7.0bufferto obtain a stock solution containing about 1mg of cefazolin per mL.Transfer 5.0mLof this solution to a 100-mLvolumetric flask,add 5.0mLof Internal standard solution,dilute with pH7.0bufferto volume,and mix.
Assay preparation 2 (where the label states the quantity of cefazolin in a given volume of constituted solution)—Constitute Cefazolin for Injection in a volume of water,accurately measured,corresponding to the volume of solvent specified in the labeling.Dilute an accurately measured volume of the constituted solution quantitatively with pH7.0bufferto obtain a stock solution containing about 1mg of cefazolin per mL.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 in the Assayunder Cefazolin.Calculate the quantity,in mg,of cefazolin (C14H14N8O4S3)in the container,and in the volume of constituted solution taken by the formula:
(CL/D)(RU/RS),
in which Lis the labeled quantity,in mg,of cefazolin in the container,or in the volume of constituted solution taken;Dis the concentration,in mg per mL,of cefazolin in the stock solution used in preparing Assay preparation 1or Assay preparation 2,on the basis of the labeled quantity in the container,or in the volume of constituted solution taken,respectively,and the extent of dilution;and the other terms are as defined therein.Where the test for Uniformity of dosage unitshas been performed using the Procedure for content uniformity,use the average of these determinations as the Assayvalue.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 376
Phone Number:1-301-816-8335