Cisplatin for Injection
» Cisplatin for Injection is a sterile, lyophilized mixture of Cisplatin, Mannitol, and Sodium Chloride. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of cisplatin (Cl2H6N2Pt).
[CautionCisplatin is potentially cytotoxic. Great care should be taken in handling the powder and preparing solutions. ]
Packaging and storage Preserve in Containers for Sterile Solids as described under Injections 1. Protect from light.
USP Reference standards 11
USP Endotoxin RS
Constituted solution At the time of use, it meets the requirements for Constituted Solutions under Injections 1.
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.
Bacterial endotoxins 85 It contains not more than 2.0 USP Endotoxin Units per mg of cisplatin.
Sterility 71 It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined.
Uniformity of dosage units 905: meets the requirements.
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
Mobile phase, Standard preparation, and Chromatographic system Proceed as directed in the test for Limit of trichloroammineplatinate under Cisplatin.
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.
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 Cl2H6N2Pt 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.
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USP35NF30 Page 2679