Dactinomycin for Injection
» Dactinomycin for Injection is a sterile mixture of Dactinomycin and Mannitol. It contains not less than 90.0 percent and not more than 120.0 percent of the labeled amount of C62H86N12O16, the labeled amount being 0.5 mg in each container.
Caution—Great care should be taken to prevent inhaling particles of Dactinomycin and exposing the skin to it.
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.”
Constituted solution— At the time of use, it meets the requirements for Constituted Solutions under Injections 1.
A: The UV absorption spectrum of a methanol solution containing about 25 µg of dactinomycin per mL exhibits maxima and minima at the same wavelengths as that of a similar solution of USP Dactinomycin RS, concomitantly measured, and the ratio A240 /A445 is between 1.30 and 1.50.
B: The chromatogram obtained from the Assay preparation in the Assay exhibits a major peak for dactinomycin, the retention time of which corresponds to that exhibited by the Standard preparation, and the chromatogram compares qualitatively to that obtained from the Standard preparation.
Bacterial endotoxins 85 It contains not more than 100.0 USP Endotoxin Units per mg of dactinomycin.
Sterility 71 It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined, 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.
pH 791: between 5.5 and 7.5, in the solution constituted as directed in the labeling.
Loss on drying 731 Dry it in vacuum at a pressure not exceeding 5 mm of mercury at 60 for 3 hours: it loses not more than 4.0% of its weight.
Other requirements— It meets the requirements under Injections 1.
Assay— [note—In this procedure, use freshly prepared Standard preparation and Assay preparation, protected from light.]
Mobile phase— Mix 6 volumes of acetonitrile and 4 volumes of water, filter through a membrane filter (1-µm or finer porosity), and degas. [note—The acetonitrile concentration may be varied to provide appropriate Chromatographic system performance and to provide a suitable elution time.]
Standard preparation— Dissolve an accurately weighed quantity of USP Dactinomycin RS in Mobile phase, and dilute quantitatively with Mobile phase to obtain a solution having a known concentration of about 250 µg of dactinomycin per mL.
Assay preparation— Add an accurately measured volume of Mobile phase to 1 container of Dactinomycin for Injection to obtain a solution containing about 250 µg of dactinomycin per mL, and filter, if necessary, to obtain a clear solution.
Chromatographic system (see Chromatography 621)—The liquid chromatograph is equipped with a 254-nm detector and a 3.9-mm × 30-cm column that contains packing L1. The flow rate is about 2.5 mL per minute. Chromatograph the Standard preparation, and record the peak response as directed under Procedure: the column efficiency is not less than 1200 theoretical plates, the tailing factor is not more than 2, and the relative standard deviation for replicate injections is not more than 3.0%.
Procedure— Separately inject equal volumes (about 10 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks. The retention time is about 6 minutes for dactinomycin. Calculate the quantity, in mg, of C62H86N12O16 in the container of Dactinomycin for Injection taken by the formula:
(CV / 1000)(rU / rS)
in which C is the concentration, in µg, of dactinomycin in each mL of the Standard preparation, V is the volume, in mL, of the Assay preparation, and rU and rS are the peak responses of the Assay preparation and the Standard preparation, respectively.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Ahalya Wise, M.S.
(MDANT05) Monograph Development-Antibiotics
Reference Standards Lili Wang, Technical Services Scientist
85 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
(MSA05) Microbiology and Sterility Assurance
71 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
(MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 2054
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.