Dactinomycin for Injection
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.
[CautionGreat care should be taken to prevent inhaling particles of Dactinomycin and exposing the skin to it. ]
• 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, 1.301.50
• B. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.
[NoteUse 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. [NotePrepare the solution by adding a suitable aliquot of Mobile phase to one container of Dactinomycin for Injection. ]
Detector: UV 254 nm
Column: 3.9-mm × 30-cm; packing L1
Flow rate: 2.5 mL/min
Injection size: 10 µL
Sample: Standard solution
[NoteThe retention time for dactinomycin is 6 min. ]
Column efficiency: NLT 1200 theoretical plates
Tailing factor: NMT 2
Relative standard deviation: NMT 3.0%
Samples: Standard solution and Sample solution
Calculate the percentage of C62H86N12O16 in the portion of Dactinomycin for Injection taken:
Result = (rU/rS) × (CS/CU) × 100
Acceptance criteria: 90.0%120.0%
• pH 791: 5.57.5, 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 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 1, Constituted Solutions.
• Packaging and Storage: Preserve in light-resistant Containers for Sterile Solids as described under Injections 1.
• Labeling: Label it to include the statement Protect from light.
• USP Reference Standards 11
USP Endotoxin RS
Auxiliary Information Please check for your question in the FAQs before contacting USP.
USP35NF30 Page 2804Pharmacopeial Forum: Volume No. 35(6) Page 1452