(dak'' tin oh mye' sin).
» 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.
USP Reference standards 11
USP Endotoxin RS
Solution: 25 µg per mL.
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.
Specific rotation 781S: between 293 and 329 measured at 20.
Test solution: 1 mg per mL, in methanol.
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.
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USP35NF30 Page 2803Pharmacopeial Forum: Volume No. 34(3) Page 589