Cefazolin for Injection
» Cefazolin for Injection contains an amount of Cefazolin Sodium equivalent to not less than 90.0 percent and not more than 115.0 percent of the labeled amount of cefazolin (C14H14N8O4S3).
Packaging and storage Preserve in Containers for Injections as described under Injections 1.
Constituted solution At the time of use, it meets the requirements for Constituted Solutions under Injections 1.
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 meets the requirements of the tests for Sodium 191.
Specific rotation 781S: between 10 and 24.
Test solution: 55 mg per mL, in 0.1 M sodium bicarbonate.
Bacterial endotoxins 85 It contains not more than 0.15 USP Endotoxin Unit per mg of cefazolin.
Sterility 71 It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined.
Uniformity of dosage units 905: meets the requirements.
Procedure for content uniformity Perform the Assay on individual containers using Assay preparation 1 or Assay preparation 2, or both, as appropriate.
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%.
Particulate matter 788: meets the requirements for small-volume injections.
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 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 pH 7.0 buffer to obtain a stock solution containing about 1 mg of cefazolin per mL. 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.
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 pH 7.0 buffer to obtain a stock solution containing about 1 mg of cefazolin per mL. 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 in the Assay under 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 L is the labeled quantity, in mg, of cefazolin in the container, or in the volume of constituted solution taken; D is the concentration, in mg per mL, of cefazolin in the stock solution used in preparing Assay preparation 1 or 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 units has been performed using the Procedure for content uniformity, use the average of these determinations as the Assay value.
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USP32NF27 Page 1824