Printed on: Fri Jan 05 2024, 10:22:23 PM(EST) Status: Currently Official on 06-Jan-2024 DocId: GUID-DBFE2C97-BCAE-4778-8E0B-9D76ED094B2F_3_en-US
Printed by: USP NF Official Date: Official as of 01-May-2018 Document Type: USP @2024 USPC
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2 mL of a 1 in 200 solution of tetramethylammonium
Digitoxin Injection hydroxide in alcohol, and mix: a red-violet color develops
slowly and then fades.
» Digitoxin Injection is a sterile solution of Digitoxin C: The retention time of the major peak in the
chromatogram of the Assay preparation corresponds to that of
in 5 to 50 percent (v/v) of alcohol, and may contain the major peak in the chromatogram of the Standard
Glycerin or other suitable solubilizing agents. It preparation as obtained in the Assay.
contains not less than 90.0 percent and not more Bacterial Endotoxins Test á85ñ —It contains not more than
than 110.0 percent of the labeled amount 111.0 USP Endotoxin Units per mg of digitoxin.
of C41H64O13. Alcohol Determination á611ñ: between 90.0% and 110.0%
of the labeled percentage of C2H5OH.
Packaging and storage—Preserve in single-dose or Other requirements—It meets the requirements under
multiple-dose containers, preferably of Type I glass, protected Injections and Implanted Drug Products á1ñ.
from light. Assay—
USP Reference standards á11ñ— Mobile phase, Standard preparation, System suitability
USP Digitoxin RS preparation, and Chromatographic system—Prepare as directed
Identification— in the Assay under Digitoxin.
A: To a portion of Injection, equivalent to about 1 mg of Assay preparation—Transfer an accurately measured
digitoxin, add 10 mL of water, and extract with 10 mL of volume of Injection, equivalent to about 1 mg of digitoxin,
chloroform. Evaporate the chloroform extract on a steam bath to a 25-mL volumetric flask. Dilute with Mobile phase to
with the aid of a current of air to dryness. Dissolve the residue volume, and mix.
Procedure—Proceed as directed for Procedure in the Assay
al
in 2 mL of a solution prepared by mixing 0.3 mL of ferric
chloride TS and 50 mL of glacial acetic acid, and underlay with under Digitoxin. Calculate the quantity, in µg, of C41H64O13 in
2 mL of sulfuric acid: at the zone of contact of the two liquids a each mL of the Injection taken by the formula:
brown color, which gradually changes to light green, then to
blue, is produced, and finally the entire acetic acid layer 25(C/V)(r U/r S)
acquires a blue color.
B: To a portion of Injection, equivalent to about 0.2 mg of
digitoxin, add 10 mL of water, and extract with 10 mL of
chloroform. Evaporate the chloroform extract on a steam bath
ci in which C is the concentration, in µg per mL, of USP
Digitoxin RS in the Standard preparation, V is the volume, in
mL, of Injection taken, and r U and r S are the peak responses
with the aid of a current of air to dryness. Add 2 mL of a freshly obtained from the Assay preparation and the Standard
prepared 1 in 100 solution of m-dinitrobenzene in alcohol, preparation, respectively.
ffi
and allow to stand for 10 minutes with frequent shaking. Add
O
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