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 90.0 percent and not more than 110.0 percent of the labeled amount of plicamycin (C52H76O24).
Packaging and storage— Preserve in light-resistant Containers for Sterile Solids as described under Injections 1, at a temperature between 2 and 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 Solutions under Injections 1.
Identification— Transfer a suitable quantity to a centrifuge tube, add methanol to obtain a solution having a concentration of about 0.5 mg of plicamycin per mL, mix, and centrifuge to obtain a clear solution. Apply 100 µL of this solution and 100 µL of a Standard solution of USP Plicamycin RS, similarly prepared to a suitable thin-layer chromatographic plate (see Chromatography 621) 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 60 minutes. 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 (1 in 100) and potassium ferricyanide solution (1 in 100). Observe the blue spots under a long-wavelength UV light: the RF value of the principal spot obtained from the test solution corresponds to that obtained from the Standard solution (RF about 0.7). Spots of trace components at RF values of about 0.4 and 0.5 are not more intense than similar spots obtained from the Standard solution.
Bacterial endotoxins 85 It contains not more than 100.0 USP Endotoxin Units per mg of plicamycin.
Sterility 71 It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined.
pH 791: between 5.0 and 7.5, in the solution constituted as directed in the labeling.
Water, Method I 921: 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 Assay under Plicamycin.
Assay preparation— Dilute the contents of 1 container of Plicamycin for Injection quantitatively with Mobile phase to obtain a solution containing about 100 µg of plicamycin per mL.
Procedure— Proceed as directed for Procedure in the Assay under Plicamycin. Calculate the quantity, in mg, of plicamycin (C52H76O24) in the container by the formula:
C(L / D)
in which C is the concentration, in µg per mL, of plicamycin in the Assay preparation; L is the labeled quantity, in mg, of plicamycin in the container; and D is the concentration, in µg per mL, of plicamycin in the Assay preparation on the basis of the labeled quantity in the container and the extent of dilution.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Ahalya Wise, M.S.
(MDANT05) Monograph Development-Antibiotics
Reference Standards Lili Wang, Technical Services Scientist
85 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
(MSA05) Microbiology and Sterility Assurance
71 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
(MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 3320
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.