Oxaliplatin Family Notice of Revision, Effective 1st Aug

Notice of Intent to Revise: Oxaliplatin, Oxaliplatin for Injection, and Oxaliplatin Injection

Type of Posting: Notice of Intent to Revise
Posting Date: 24-Apr-2026
Targeted Official Date: 01-Aug-2026
Revision Vehicle: Revision Bulletin
Expert Committee: Small Molecules Therapeutic Areas 3

In accordance with the Rules and Procedures of the Council of Experts, this is to provide notice that the Small Molecules Therapeutic Areas 3 intends to revise the Oxaliplatin family of monographs to accommodate the introduction of a different form of the USP Oxaliplatin Related compound B RS.

To address the continuity of supply and improved solubility of the USP Oxaliplatin Related Compound B, USP is introducing the 4-methylbenzenesulfonato dihydrate form of this Reference Standard as the replacement of previously available dinitrato complex.

To accommodate this change, the following revisions are proposed:

• Oxaliplatin
  • In the test for Assay:
  • Update the concentration of USP Oxaliplatin Related Compound B RS in the preparation of the Oxaliplatin related compound B standard stock solution to maintain the concentration of the impurity in the solution based on the new form of the Reference Standard (from 0.125 mg/mL to 0.2 mg/mL)
  • In the Organic Impurities, Procedure 2: Limit of (SP-4-2-)-Diaqua[(1R,2R)-cyclohexane-1,2-diamine-N,N′]platinum, Oxaliplatin Related Compound C, and Unspecified Impurities test:
  • Update the concentration of USP Oxaliplatin Related Compound B RS in the preparation of the Standard solution to maintain the concentration of the impurity in the solution based on the new form of the Reference Standard (from 0.01 mg/mL to 0.016 mg/mL)
  • Revise the molecular weight of USP Oxaliplatin Related Compound B RS in the equations (from 433.28 to 687.69)
• Oxaliplatin for Injection
  • In the Limit of (SP-4-2)-Diaqua[(1R,2R)-cyclohexane-1,2-diamine-N,N′]platinum test:
  • Update the concentration of USP Oxaliplatin Related Compound B RS in the preparation of the Standard solution to maintain the concentration of the impurity in the solution based on the new form of the Reference Standard (from 0.0125 mg/mL to 0.02 mg/mL)
  • Revise the molecular weight of USP Oxaliplatin Related Compound B RS in the equation (from 433.28 to 687.69)
• Oxaliplatin Injection
  • In the Limit of (SP-4-2)-Diaqua[(1R,2R)-cyclohexane-1,2-diamine-N,N′]platinum and Unspecified Impurities test:
  • Update the concentrations of USP Oxaliplatin Related Compound B RS in the preparation of the Standard stock solution and Standard solution to maintain the concentration of the impurity in the solutions based on the new form of the Reference Standard (from 0.125 mg/mL to 0.2 mg/mL for the Standard stock solution; from 31.25 µg/mL to 49.6 µg/mL for the Standard solution)
  • Revise the molecular weight of USP Oxaliplatin Related Compound B RS in the equation (from 433.28 to 687.69) In addition to the above changes, the chemical name, chemical formula, and molecular weight for USP Oxaliplatin Related Compound B RS in the USP Reference Standards <11> sections of all three monographs are updated to reflect the new form of Reference Standard as follows:

Replace:
Chemical name: [SP-4-2-(1R-trans)]-(1,2-Cyclohexanediamine-N,N′) dinitratoplatinum(II)
Chemical formula: C6H14N4O6Pt
Molecular weight: 433.28

With:
Chemical name: [SP-4-2-(1R-trans)]-[(1,2-Cyclohexanediamine-N,N’)bis(4-methylbenzenesulfonato)] platinum(II) dihydrate
Chemical formula: C20H28N2O6PtS2 · 2H2O
Molecular weight: 687.69

It is anticipated that the proposed revision will be published on July 31, 2026 as a Revision Bulletin pursuant to the Rules and Procedures and will become official on August 1, 2026.

Should you have any questions, please contact Robyn Fales, Senior Scientist II (rnp@usp.org).