Dactinomycin
» Dactinomycin contains not less than 950 µg and not more than 1030 µg of C62H86N12O16 per mg, calculated on the dried basis.
CautionGreat care should be taken to prevent inhaling particles of Dactinomycin and exposing the skin to it.
Packaging and storage
Preserve in tight containers, protected from light and excessive heat.
Identification
Solution:
25 µg per mL.
Medium:
methanol.
Absorptivity at 445 nm, calculated on the dried basis, is not less than 95.0% and not more than 103.0% of that of USP Dactinomycin RS, the potency of the Reference Standard being taken into account.
Ratio:
A240/A445 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.
Crystallinity 695:
meets the requirements.
Bacterial endotoxins 85
It contains not more than 100 USP Endotoxin Units per mg.
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 5.0% of its weight.
Assay
[noteIn this procedure, use a freshly prepared Standard preparation and Assay preparation, protected from light.]
Mobile phase
Prepare a suitable mixture of acetonitrile, 0.04 M sodium acetate, and 0.07 M acetic acid (approximately 46:25:25), filter through a membrane filter (1-µm or finer porosity), and degas. [noteThe 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 1200 µg of dactinomycin per mL.
Assay preparation
Dissolve about 30 mg of Dactinomycin, accurately weighed, in Mobile phase to make 25.0 mL, and mix.
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 1.0 mL per minute. Chromatograph three replicate injections of the Standard preparation, and record the peak responses as directed under Procedure: the relative standard deviation is not more than 1.0%.
Procedure
Separately inject equal volumes (about 20 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 25 minutes for Dactinomycin. Calculate the potency, in µg, of C62H86N12O16 per mg taken by the formula:
25(C / W)(rU / rS)
in which C is the concentration, in µg, of dactinomycin in each mL of the Standard preparation; W is the weight, in mg, of Dactinomycin taken; 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.
Chromatographic Column
USP32NF27 Page 2053
Pharmacopeial Forum: Volume No. 34(3) Page 589
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.
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