Dactinomycin 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

Dactinomycin for Injection is a sterile mixture of Dactinomycin and Mannitol. It contains NLT 90.0% and NMT 120.0% of the labeled amount of C₆₂H₈₆N₁₂O₁₆

[CAUTION-Great care should be taken to prevent inhaling particles of Dactinomycin and exposing the skin to it.]

2 IDENTIFICATION

2.1 A. PROCEDURE

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

Sample solution: 25 µg/mL of dactinomycin in methanol

Acceptance criteria: The UV absorption spectrum of the Sample solution exhibits maxima and minima at the same wavelengths as the Standard solution, concomitantly measured.

Ratio: A₂₄₀/A₄₄₅ 1.30-1.50

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

[NOTE-Use freshly prepared Standard solution and Sample solution, protected from light.]

Mobile phase: Acetonitrile and water (3:2)

Standard solution: 250 µg/mL of USP Dactinomycin RS in Mobile phase

Sample solution: 250 µg/mL of dactinomycin from

Dactinomycin for Injection diluted with Mobile phase. Filter, if necessary, to obtain a clear

solution. [NOTE-Prepare the solution by adding a suitable aliquot of Mobile phase to one container of Dactinomycin for Injection.]

Chromatographic system

OFFICIAL

(See Chromatography (621), System Suitability.)

Mode: LC

Detector: UV 254 nm

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

Flow rate: 2.5 mL/min

Injection size: 10 µL

System suitability

Sample: Standard solution

[NOTE-The retention time for dactinomycin is 6 min.]

Suitability requirements

Column efficiency: NLT 1200 theoretical plates

Tailing factor: NMT 2

Relative standard deviation: NMT 3.0%

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of C₆₂H₈₆N₁₂O₁₆ in the portion of Dactinomycin for Injection taken: 

Result = (r_u/r_s) x (C_s/C_u) × 100

r_u = peak response from the Sample solution

r_s = peak response from the Standard solution

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

C_u = nominal concentration of dactinomycin in the Sample solution (µg/mL)

Acceptance criteria: 90.0%-120.0%

4 SPECIFIC TESTS

PH (791): 5.5-7.5, in the solution constituted as directed in the labeling

LOSS ON DRYING (731): Dry a portion in vacuum at a pressure not exceeding 5 mm of mercury at 60° for 3 h: it loses NMT 4.0% of its weight.

OTHER REQUIREMENTS: It meets the requirements under Injections and Implanted Drug Products (1).

BACTERIAL ENDOTOXINS TEST (85): NMT 100.0 USP Endotoxin Units/mg of dactinomycin.

STERILITY TESTS (71): Meets the requirements when tested as directed for Test for Sterility of the Product to be Examined, Membrane Filtration, each container being constituted aseptically by injecting Sterile Water for Injection through the stopper, and the entire contents of all the containers being collected aseptically with the aid of 200 mL of Fluid A before filtering.

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 and for Labeling (7), Labels and Labeling for Injectable Products.

5 ADDITIONAL REQUIREMENTS

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

LABELING: Label it to include the statement "Protect from light."

USP REFERENCE STANDARDS (11)

USP Dactinomycin RS