Dactinomycin

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

Dactinomycin contains NLT 950 µg/mg and NMT 1030 µg/mg of dactinomycin (C₆₂H₈₆N₁₂O₁₆), calculated on the dried basis. [CAUTION-Great care should be taken to prevent inhaling particles of Dactinomycin and exposing the skin to it.]

2 IDENTIFICATION

2.1 A. SPECTROSCOPIC IDENTIFICATION TESTS (197), Ultraviolet-Visible Spectroscopy: 197U

Standard solution: 25 µg/mL of dactinomycin from USP Dactinomycin RS in methanol

Sample solution: 25 µg/mL in methanol

Analytical wavelengths: 240 and 445 nm

Acceptance criteria

Absorptivity: The absorptivity, calculated on the dried basis, of the Sample solution at 445 nm is NLT 95.0% and NMT 103.0% that of the Standard solution.

Ratio: A₂₄₀/A₄₄₅ 1.30-1.50, Sample solution

2.2 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

3.1 PROCEDURE

Mobile phase: Acetonitrile, 0.04 M sodium acetate, and 0.07 M acetic acid (46:25:25). Pass through a filter of 1-µm or finer pore size. The acetonitrile concentration may be varied to provide appropriate chromatographic system performance and a suitable elution time.

Standard solution: 1.2 mg/mL of USP Dactinomycin RS in Mobile phase. Use a freshly prepared solution, and protect it from light.

Sample solution: 1.2 mg/mL of Dactinomycin in Mobile phase. Use a freshly prepared solution, and protect it from light.

Chromatographic system

(See Chromatography (621), System Suitability.)

Mode: LC

Detector: UV 254 nm

Column: 3.9-mm x 30-cm; packing L1

Flow rate: 1 mL/min

Injection volume: 20 µL

System suitability

Sample: Standard solution

[NOTE-The retention time for dactinomycin is about 25 min.]

USP-NF Dactinomycin

Suitability requirements

Relative standard deviation: NMT 1.0%, dactinomycin (3 replicate injections)

Analysis

Samples: Standard solution and Sample solution

Calculate the potency, in µg/mg, of dactinomyin (C₆₂H₈₆N₁₂O₁₆) in the Dactinomycin taken:

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

r_u = peak response from the Sample solution

r_s = peak response from the Standard solution S

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

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

P = potency of dactinomycin in USP Dactinomycin RS (mg/mg)

F = conversion factor, 1000 µg/mg

Acceptance criteria: 950-1030 µg/mg on the dried basis

4 SPECIFIC TESTS

4.1 OPTICAL ROTATION, Specific Rotation (781S)

Sample solution: 1 mg/mL in methanol

Acceptance criteria: -293° to -329° (t = 20 deg)

4.2 CRYSTALLINITY (695): Meets the requirements

4.3 LOSS ON DRYING (731)

Analysis: Dry under vacuum at a pressure not exceeding 5 mm of mercury at 60° for 3 h.

Acceptance criteria: NMT 5.0%

4.4 BACTERIAL ENDOTOXINS TEST (85):

It contains NMT 100 USP Endotoxin Units/mg.

5 ADDITIONAL REQUIREMENTS

5.1 PACKAGING AND STORAGE:

Preserve in tight containers, protected from light and excessive heat.

5.2 USP REFERENCE STANDARDS (11)

USP Dactinomycin RS