Assay
Mobile phase
,
Phosphate buffer,
Standard preparation, and
Chromatographic systemPrepare as directed in the
Assay under
Cefoxitin Sodium.
Assay preparation 1
(where it is represented as being in a single-dose container)Constitute Cefoxitin 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 water to obtain a solution having a concentration of about 0.3 mg of cefoxitin per mL. Use this solution within 5 hours.
Assay preparation 2
(where the label states the quantity of cefoxitin in a given volume of constituted solution)Constitute Cefoxitin 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 water to obtain a solution containing about 0.3 mg of cefoxitin per mL. Use this solution within 5 hours.
Procedure
Proceed as directed in the
Assay under
Cefoxitin Sodium. Calculate the quantity, in mg, of cefoxitin (C
16H
17N
3O
7S
2) in the portion of constituted solution taken by the formula:
0.001(CP)(L / D)(rU / rS),
in which
L is the labeled quantity, in mg, in the portion of constituted solution taken;
D is the concentration, in mg per mL, of
Assay preparation 1 or
Assay preparation 2, based on the volume of constituted solution taken and the extent of dilution; and the other terms are as defined therein.