Dactinomycin for Injection
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.
]
IDENTIFICATION
• 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
• B.
The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.
ASSAY
• 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
Mode:
LC
Detector:
UV 254 nm
Column:
3.9-mm × 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 = (rU/rS) × (CS/CU) × 100
| rU | = | = peak response from the Sample solution |
| rS | = | = peak response from the Standard solution |
| CS | = | = concentration of USP Dactinomycin RS in the Standard solution (µg/mL) |
| CU | = | = nominal concentration of dactinomycin in the Sample solution (µg/mL) |
Acceptance criteria:
90.0%–120.0%
SPECIFIC TESTS
• pH 
791
:
5.5–7.5, in the solution constituted as directed in the labeling
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.
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.
1.
• Bacterial Endotoxins Test 85:
NMT 100.0 USP Endotoxin Units/mg of dactinomycin.
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.
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.
1, Constituted Solutions.
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in light-resistant Containers for Sterile Solids as described under Injections 1.
1.
• Labeling:
Label it to include the statement “Protect from light.”
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Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Ahalya Wise, M.S.
Senior Scientific Liaison 1-301-816-8161 |
(SM12010) Monographs - Small Molecules 1 |
| 85 |
Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison 1-301-816-8339 |
(GCM2010) General Chapters - Microbiology |
| 71 |
Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison 1-301-816-8339 |
(GCM2010) General Chapters - Microbiology |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 2804
Pharmacopeial Forum: Volume No. 35(6) Page 1452