Cefamandole Nafate for Injection
» Cefamandole Nafate for Injection is a sterile mixture of Cefamandole Nafate and one or more suitable buffers. It has a potency equivalent to not less than 810 µg and not more than 1000 µg of cefamandole (C18H18N6O5S2) per mg, calculated on the anhydrous and sodium carbonate-free basis. It contains the equivalent of not less than 90.0 percent and not more than 115.0 percent of the labeled amount of cefamandole (C18H18N6O5S2).
Packaging and storage Preserve in Containers for Sterile Solids as described under Injections 1.
USP Reference standards 11
USP Endotoxin RS
Constituted solution At the time of use, it meets the requirements for Constituted Solutions under Injections 1.
Identification It responds to the Identification test under Cefamandole Nafate.
Bacterial endotoxins 85 It contains not more than 0.15 USP Endotoxin Unit per mg of cefamandole.
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 6.0 and 8.0, determined after 30 minutes in a solution containing 100 mg per mL.
Water, Method I 921: not more than 3.0%.
Particulate matter 788: meets the requirements for small-volume injections.
Other requirements It meets the requirements under Injections 1.
pH 2.3 Buffer and Standard preparation Prepare as directed in the Assay under Cefamandole Nafate.
Assay preparation 1 (where the article is represented as being in a single-dose container)Constitute Cefamandole Nafate 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 2 mg of cefamandole per mL. Transfer 5.0 mL of this solution to a 50-mL volumetric flask, add 30.0 mL of pH 2.3 Buffer, dilute with water to volume, and mix.
Assay preparation 2 (where the label states the quantity of cefamandole in a given volume of constituted solution)Constitute Cefamandole Nafate for Injection in a volume of water, accurately measured, corresponding to the volume of solvent specified in the labeling. Quantitatively dilute an accurately measured volume of the constituted solution with water to obtain a solution containing about 2 mg of cefamandole per mL. Transfer 5.0 mL of this solution to a 50-mL volumetric flask, add 30.0 mL of pH 2.3 Buffer, dilute with water to volume, and mix.
Assay preparation 3 Using an accurately weighed quantity of Cefamandole Nafate for Injection, prepare as directed for Standard preparation under Cefamandole Nafate. Determine the sodium carbonate content of a separate, accurately weighed, 1-g portion of Cefamandole Nafate for Injection dissolved in 100 mL of water. Add methyl orange TS, and titrate with 0.2 N sulfuric acid VS. Each mL of 0.2 N sulfuric acid is equivalent to 10.60 mg of Na2CO3.
Procedure Proceed as directed for Procedure in the Assay under Cefamandole Nafate. Calculate the quantity, in mg, of cefamandole (C18H18N6O5S2) in the portion of constituted solution taken by the formula:
(CP)(L / 1000D)(iU / iS)in which C is the concentration, in mg per mL, of USP Cefamandole Nafate RS in the Standard preparation; L is the labeled quantity, in mg, in the portion of constituted solution taken; D is the concentration, in mg per mL, of cefamandole in Assay preparation 1 or in Assay preparation 2, based on the volume of constituted solution taken and the extent of dilution; and the other terms are as defined therein. Calculate the potency, in µg of cefamandole (C18H18N6O5S2) per mg, of the Cefamandole Nafate for Injection taken by the formula:
(CP / W)(iU / iS)in which W is the weight, in mg, of the Cefamandole Nafate for Injection taken in each mL of Assay preparation 3, 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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USP35NF30 Page 2532Pharmacopeial Forum: Volume No. 37(3)