Plicamycin for Injection
»Plicamycin for Injection is a sterile,dry mixture of Plicamycin and Mannitol.It may contain a suitable buffer.It contains not less than 90.0percent and not more than 110.0percent of the labeled amount of plicamycin (C52H76O24).
Packaging and storage— Preserve in light-resistant Containers for Sterile Solidsas described under Injections á1ñ,at a temperature between 2and 8.
Labeling— Label it with the mandatory instruction to consult the professional information for dosage and warnings,and with the warning that it is intended for hospital use only,under the direct supervision of a physician.
Constituted solution— At the time of use,it meets the requirements for Constituted Solutionsunder Injections á1ñ.
Identification— Transfer a suitable quantity to a centrifuge tube,add methanol to obtain a solution having a concentration of about 0.5mg of plicamycin per mL,mix,and centrifuge to obtain a clear solution.Apply 100µLof this solution and 100µLof a Standard solution of USP Plicamycin RS,similarly prepared to a suitable thin-layer chromatographic plate (see Chromatography á621ñ)coated with a 0.25-mm layer of chromatographic silica gel mixture.Allow the spots to dry,and develop the chromatograms in a solvent system consisting of a mixture chloroform and methanol (1:1)for about 60minutes.Remove the plate from the developing chamber,mark the solvent front,and allow the solvent to evaporate.Spray the plate with a (1:1)mixture of ferric chloride solution (1in 100)and potassium ferricyanide solution (1in 100).Observe the blue spots under a long-wavelength UVlight:the RFvalue of the principal spot obtained from the test solution corresponds to that obtained from the Standard solution (RFabout 0.7).Spots of trace components at RFvalues of about 0.4and 0.5are not more intense than similar spots obtained from the Standard solution.
Bacterial endotoxins á85ñ— It contains not more than 100.0USP Endotoxin Units per mg of plicamycin.
Sterility á71ñ— It meets the requirements when tested as directed for Membrane Filtrationunder Test for Sterility of the Product to be Examined.
pHá791ñ: between 5.0and 7.5,in the solution constituted as directed in the labeling.
Water,Method Iá921ñ: not more than 2.0%.
Assay— [NOTE—Prepare solutions of plicamycin in low-actinic glassware.]
Mobile phase,Standard preparation,and Chromatographic system— Proceed as directed in the Assayunder Plicamycin.
Assay preparation— Dilute the contents of 1container of Plicamycin for Injection quantitatively with Mobile phaseto obtain a solution containing about 100µg of plicamycin per mL.
Procedure— Proceed as directed for Procedurein the Assayunder Plicamycin.Calculate the quantity,in mg,of plicamycin (C52H76O24)in the container by the formula:
C(L/D),
in which Cis the concentration,in µg per mL,of plicamycin in the Assay preparation;Lis the labeled quantity,in mg,of plicamycin in the container;and Dis the concentration,in µg per mL,of plicamycin in the Assay preparationon the basis of the labeled quantity in the container and the extent of dilution.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1571
Phone Number:1-301-816-8335