Constituted solution—
At the time of use, it meets the requirements for
Constituted Solutions under
Injections 
1
.
Identification—
Spray reagent—
Prepare as directed for
Spray reagent in
Identification test
C under
Cisplatin.
Standard preparation—
Prepare a solution containing 1.0 mg of
USP Cisplatin RS per mL, 9 mg of sodium chloride per mL, and 10 mg of
D-mannitol per mL, in water.
Test preparation—
Dissolve the contents of 1 container in water to provide a Cisplatin concentration of 1.0 mg per mL, based on label claim.
Procedure—
Proceed as directed for
Procedure in
Identification test
C under
Cisplatin, beginning with “Apply separately 5-µL quantities.” The principal spot from the
Test preparation corresponds in appearance and
RF value to that from the
Standard preparation.
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 3.5 and 6.2, in the solution constituted as directed in the labeling, using Sterile Water for Injection.
Water, Method I 921—
Use anhydrous formamide as the extraction solvent, and use the following procedure. Introduce about 50 mL of anhydrous formamide into the titration vessel, and titrate with the
Reagent to the electrometric endpoint. Use the formamide thus dried to rinse a suitable glass syringe equipped with a 22-gauge needle, about 8 cm long. Add the rinse back to the titration vessel, and again titrate the vessel contents, if necessary. Via the syringe, withdraw 5 mL of the formamide thus titrated, and, through the closure of the container, expel the contents into the container. Shake the container to obtain a solution. With the same syringe, withdraw all of the contents of the container, and transfer to the titration vessel. Titrate to the endpoint, adjusting the feeding speed control to the lowest setting, to avoid over-titration. The amount of water found is not more than 2.0%.
Limit of trichloroammineplatinate—
Test preparation—
Using low-actinic volumetric glassware, quantitatively dissolve with water the contents of 1 container to yield a 0.5 mg per mL solution of Cisplatin.
Procedure—
Proceed as directed for
Procedure in the test for
Limit of trichloroammineplatinate under
Cisplatin. Calculate the percentage of trichloroammineplatinate taken by the formula:
0.1(318.48/357.58)(rU / rS)(CV/W),
in which 318.48 and 357.58 are the formula weights of trichloroammineplatinate and potassium trichloroammineplatinate, respectively;
rU and
rS are the peak areas obtained from the
Test preparation and the
Standard preparation, respectively;
C is the concentration, in µg per mL, of the
Standard preparation; V is the volume, in mL, of the constituted container contents; and
W is the labeled amount, in mg, of Cisplatin per container. Not more than 1.0% is found.
Limit of transplatin—
Mobile phase, Stock standard solution, Working standard solution, Standard preparation, Resolution solution, and Chromatographic system—
Proceed as directed in the test for
Limit of transplatin under
Cisplatin.
Test solution—
Quantitatively dissolve the contents of 1 container with water to yield a 0.5 mg per mL solution of Cisplatin.
Test preparation—
Prepare as directed for
Test preparation in the test for
Transplatin under
Cisplatin.
Procedure—
Proceed as directed for
Procedure in the test for
Limit of transplatin under
Cisplatin. Calculate the percentage of transplatin taken by the formula:
0.1(CV/W)(rU / rS),
in which
C is the concentration, in µg per mL, of the
Standard preparation; V is the volume, in mL, of the constituted container contents;
W is the labeled amount, in mg, of Cisplatin per container; and
rU and
rS are the peak areas obtained from the
Test preparation and the
Standard preparation, respectively. Not more than 2.0% is found.
Assay—
Mobile phase, Standard preparation, and Chromatographic system—
Proceed as directed in the
Assay under
Cisplatin.
Assay preparation—
Quantitatively dissolve the Cisplatin in 1 container by sonicating for 5 minutes with dimethylformamide to yield a Cisplatin concentration of about 1.0 mg per mL. Filter 5 mL through a suitable membrane filter, and collect the filtrate after discarding the first mL passing through the filter.
Procedure—
Proceed as directed for
Procedure in the
Assay under
Cisplatin. Calculate the quantity, in mg, of Cl
2H
6N
2Pt in the container taken by the formula:
CV(rU / rS),
in which
C is the concentration, in mg per mL, of
USP Cisplatin RS in the
Standard preparation;
V is the volume, in mL, of the constituted container contents; and
rU and
rS are the peak responses obtained from the
Assay preparation and the
Standard preparation, respectively.
