Valrubicin Intravesical Solution
Valrubicin Intravesical Solution is a sterile solution of Valrubicin in a suitable vehicle. It contains NLT 95.0% and NMT 105.0% of the labeled amount of valrubicin (C34H36F3NO13).
• A. Thin-Layer Chromatographic Identification Test 201
Standard solution: Use the Standard solution, prepared as directed in the Assay, suitably diluted with methanol.
Sample solution: Use the Sample solution, prepared as directed in the Assay, suitably diluted with methanol.
Solution A: 0.1 M ammonium formate. Adjust with formic acid to a pH of 4.0.
Developing solvent system: Acetonitrile and Solution A (45:55)
• B. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.
Buffer: 0.1 M ammonium formate. Adjust with formic acid to a pH of 4.0.
Mobile phase: Acetonitrile and Buffer (45:55)
Standard solution: 0.2 mg/mL of USP Valrubicin RS in methanol
Sample solution: Equivalent to 0.2 mg/mL of valrubicin, from Intravesical Solution in methanol
Detector: UV 254 mm
Column: 5-mm × 10-cm; 4-µm packing L1, and a guard column
Flow rate: 2.5 mL/min
Injection size: 10 µL
Sample: Standard solution
Relative standard deviation: NMT 2%
Samples: Standard solution and Sample solution
Calculate the percentage of the labeled amount of C34H36F3NO13 in the Intravesical Solution taken:
Result = (rU/rS) × (CS/CU) × 100
Acceptance criteria: 95.0%105.0%
Buffer, Mobile phase, and Chromatographic system: Proceed as directed in the Assay.
Sample solution: 0.2 mg/mL of valrubicin in methanol
Sample: Sample solution
Measure the areas for the major peaks. Calculate the percentage of each impurity in the portion of Intravesical Solution taken:
Result = (rU/rT) × 100
[NoteDo not consider any peaks due to solvent or excipients. ]
Individual impurities: See Impurity Table 1.
Total impurities: NMT 3.5%
Impurity Table 1
• Bacterial Endotoxins Test 85: NMT 0.14 USP Endotoxin Unit/mg of valrubicin
• pH 791: 4.07.0 in a solution equivalent to 66.7 mg/mL of valrubicin in 0.9% sodium chloride solution
• Other Requirements: Meets the requirements under Injections 1
• Packaging and Storage: Preserve in single-dose or multiple-dose containers, preferably of Type I glass. Store in a refrigerator.
• Labeling: Label it to indicate that it is not intended for intravenous or intramuscular injection but is to be used for intravesical instillation.
• USP Reference Standards 11
USP Endotoxin RS
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USP35NF30 Page 4996Pharmacopeial Forum: Volume No. 34(6) Page 1486