Cephalothin Injection
»Cephalothin Injection contains an amount of Cephalothin Sodium equivalent to not less than 90.0percent and not more than 115.0percent of the labeled amount of cephalothin (C16H16N2O6S2).
Packaging and storage— Preserve in Containers for Injectionsas described under Injections á1ñ.Maintain in the frozen state.
Labeling— It meets the requirements for Labelingunder Injections á1ñ.The label states that it is to be thawed just prior to use,describes conditions for proper storage of the resultant solution,and directs that the solution is not to be refrozen.
Bacterial endotoxins á85ñ— It contains not more than 0.13USP Endotoxin Unit per mg of cephalothin.
pHá791ñ: between 6.0and 8.5.
Particulate matter á788ñ: meets the requirements for small-volume injections.
Other requirements— It responds to the Identificationtest Aunder Cephalothin Sodiumand meets the requirements for Sterilityunder Cephalothin for Injection.
Assay—
Mobile phase,Standard preparation,Resolution solution,and Chromatographic system— Proceed as directed in the Assayunder Cephalothin Sodium.
Assay preparation— Transfer an accurately measured volume of Injection,equivalent to about 100mg of cephalothin (C16H16N2O6S2),to a 100-mLvolumetric flask,dilute with Mobile phaseto volume,and mix.
Procedure— Proceed as directed for Procedurein the Assayunder Cephalothin Sodium.Calculate the quantity,in µg,of cephalothin (C16H16N2O6S2)in each mLof the Injection taken by the formula:
100(CP/V)(rU/rS),
in which Cis the concentration,in mg per mL,of USP Cephalothin Sodium RS,in the Standard preparation,Pis the assigned potency,in µg of cephalothin (C16H16N2O6S2)per mg,of USP Cephalothin Sodium RS,Vis the volume,in mL,of Injection taken to prepare the Assay preparation,and rUand rSare the cephalothin peak responses obtained from the Assay preparationand the Standard preparation,respectively.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 417
Phone Number:1-301-816-8335