Mitomycin for Injection

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

Mitomycin for Injection contains NLT 90.0% and NMT 120.0% of the labeled amount of mitomycin (C₁₅H₁₈N₄O₅).

2 IDENTIFICATION

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

3 ASSAY

PROCEDURE

Mobile phase: Dissolve 1.54 g of ammonium acetate in 250 mL of methanol. Add 5.0 mL of 0.83 N acetic acid and water to make 1000 mL.

System suitability solution: 0.5 mg/mL of USP Mitomycin RS and 7.5 mg/mL of 3-ethoxy-4-hydroxy benzaldehyde in N,N-dimethylacetamide

Standard solution: 0.5 mg/mL of USP Mitomycin RS in N,N-dimethylacetamide

Sample solution: Add an accurately measured volume of N,N-dimethylacetamide to 1 container of Mitomycin for Injection to obtain a solution that is nominally 0.5 mg/mL of mitomycin.

Chromatographic system

(See Chromatography (621), System Suitability.)

Mode: LC

Detector: UV 365 nm

Column: 3.9 - mm x 30 - 1 cm; 10-µm packing L11

Flow rate: 2 mL/min

Injection volume: 10 µL

System suitability

Samples: System suitability solution and Standard solution

[NOTE-The relative retention times for mitomycin and 3-ethoxy-4-hydroxybenzaldehyde are 1.0 and 1.4, respectively.]

Suitability requirements

Resolution: NLT 1.8 between mitomycin and 3-ethoxy-4-hydroxybenzaldehyde, System suitability solution

Tailing factor: NMT 1.3, Standard solution

Relative standard deviation: NMT 2.0%, Standard solution

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of mitomycin (C₁₅H₁₈N₄O₅) in the container of Mitomycin for Injection taken:

Result = (r_u /r_s ) × (C_s /C_u ) × P × F × 100

r_u = peak area from the Sample solution

r_s = peak area from the Standard solution

C_s = concentration of USP Mitomycin RS in the Standard solution (mg/mL)

C_u = nominal concentration of mitomycin in the Sample solution (mg/mL)

P = potency of mitomycin in USP Mitomycin RS (µg/mg)

F = conversion factor, 0.001 mg/µg

Acceptance criteria: 90.0%–120.0%

4 PERFORMANCE TESTS

UNIFORMITY OF DOSAGE UNITS (905); Meets the requirements

5 SPECIFIC TESTS

PH (791)

Sample solution: Constitute as directed in the labeling.

Acceptance criteria: 6.0-8.0 where it contains mannitol, and 5.5-8.5 where it contains hydroxypropyl betadex

WATER DETERMINATION, Method la(921)

Sample solution: Prepare as directed for a hygroscopic specimen, using the pooled contents of five containers.

Acceptance criteria: NMT 5.0%

BACTERIAL ENDOTOXINS TEST (85): Contains NMT 10.0 USP Endotoxin Units/mg of mitomycin

STERILITY TESTS (71): Meets the requirements when tested as directed for Test for Sterility of the Product to Be Examined, Membrane Filtration

CONSTITUTED SOLUTION: At the time of use, it meets the requirements for Injections and Implanted Drug Products (1), Specific Tests, Completeness and clarity of solutions.

OTHER REQUIREMENTS: Meets the requirements in Injections and Implanted Drug Products (1)

6 ADDITIONAL REQUIREMENTS

PACKAGING AND STORAGE: Preserve as described in Packaging and Storage Requirements (659), Injection Packaging, Packaging for constitution.

protected from light. Store at 25^o, excursions permitted between 15^o and 30^o.

USP REFERENCE STANDARDS (11)

USP Mitomycin RS