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 810µg and not more than 1000µg of cefamandole (C18H18N6O5S2)per mg,calculated on the anhydrous and sodium carbonate-free basis.It contains the equivalent of not less than 90.0percent and not more than 115.0percent of the labeled amount of cefamandole (C18H18N6O5S2).
Packaging and storage— Preserve in Containers for Sterile Solidsas described under Injections á1ñ.
Constituted solution— At the time of use,it meets the requirements for Constituted Solutionsunder Injections á1ñ.
Identification— It responds to the Identificationtest under Cefamandole Nafate.
Bacterial endotoxins á85ñ— It contains not more than 0.15USP Endotoxin Unit per mg of cefamandole.
Sterility á71ñ— 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 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 6.0and 8.0,determined after 30minutes in a solution containing 100mg per mL.
Water,Method Iá921ñ: not more than 3.0%.
Particulate matter á788ñ: meets the requirements for small-volume injections.
Other requirements— It meets the requirements under Injections á1ñ.
Assay—
pH2.3Bufferand Standard preparation— Prepare as directed in the Assayunder 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 2mg of cefamandole per mL.Transfer 5.0mLof this solution to a 50-mLvolumetric flask,add 30.0mLof pH2.3buffer,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 2mg of cefamandole per mL.Transfer 5.0mLof this solution to a 50-mLvolumetric flask,add 30.0mLof pH2.3buffer,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 preparationunder Cefamandole Nafate.Determine the sodium carbonate content of a separate,accurately weighed,1-g portion of Cefamandole Nafate for Injection dissolved in 100mLof water.Add methyl orange TS,and titrate with 0.2Nsulfuric acid VS.Each mLof 0.2Nsulfuric acid is equivalent to 10.60mg of Na2CO3.
Procedure— Proceed as directed for Procedurein the Assayunder 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 Cis the concentration,in mg per mL,of USP Cefamandole Nafate RSin the Standard preparation,Lis the labeled quantity,in mg,in the portion of constituted solution taken;Dis the concentration,in mg per mL,of cefamandole in Assay preparation 1or 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 Wis the weight,in mg,of the Cefamandole Nafate for Injection taken in each mLof Assay preparation 3,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 374
Phone Number:1-301-816-8335