Valrubicin Intravesical Solution

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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1 DEFINITION

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).

2 IDENTIFICATION

Change to read:

A. The UV spectrum of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.

B. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.

3 ASSAY

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3.1 Procedure

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: Nominally equivalent to 0.2 mg/mL of valrubicin prepared as follows. Transfer a portion of Intravesical Solution to a suitable volumetric flask and dilute with methanol to volume.

Chromatographic system

• (See Chromatography 〈621〉, System Suitability.)
• Mode: LC
• Detector: UV 254 nm. For Identification A, use a diode array detector in the range of 200–400 nm.
• Columns: 5-mm × 10-cm; 4-µm packing L1; and a guard column
• Flow rate: 2.5 mL/min
• Injection volume: 10 µL

System suitability

• Sample: Standard solution
• Suitability requirements
• Tailing factor: NMT 2.0
• Relative standard deviation: NMT 2%

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of valrubicin (C₃₄H₃₆F₃NO₁₃) in the portion of Intravesical Solution taken:

Result = (rᵤ/rₛ) × (Cₛ/Cᵤ) × 100

rᵤ = peak response from the Sample solution

rₛ = peak response from the Standard solution

Cₛ = concentration of USP Valrubicin RS in the Standard solution (mg/mL)

Cᵤ = nominal concentration of valrubicin in the Sample solution (mg/mL)

Acceptance criteria: 95.0%–105.0%

4 IMPURITIES

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4.1 Organic Impurities

Buffer, Mobile phase, and Chromatographic system: Proceed as directed in the Assay.

Sample solution: 0.2 mg/mL of valrubicin in methanol

Analysis

Sample: Sample solution

Calculate the percentage of any specified and unspecified impurities in the portion of Intravesical Solution taken:

Result = (r_U/r_T) × 100

r_U = peak area for any specified or unspecified impurity

r_T = sum of the areas of all the peaks

Acceptance criteria: See Table 1.

Table 1

5 SPECIFIC TESTS

Change to read:

Bacterial Endotoxins Test 〈85〉: Meets the requirements

Add the following:

Sterility Tests 〈71〉: Meets the requirements

pH 〈791〉

• Sample solution: 1 in 15 solution in 0.9% sodium chloride solution
• Acceptance criteria: 4.0–7.0

Other Requirements: Meets the requirements under Injections and Implanted Drug Products 〈1〉

6 ADDITIONAL REQUIREMENTS

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 Valrubicin RS