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.
pH 791:
between 5.0 and 7.5, in the solution constituted as directed in the labeling.
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 (C
52H
76O
24) 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.
