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USP 39 Official Monographs / Idarubicin 4275

solution contains a mixture of 4-demethoxydaunorubicinone Change to read:


and idarubicin.
Chromatographic system (see Chromatography 〈621〉)—The •Bacterial Endotoxins Test 〈85〉• (CN 1-May-2016)—It contains
liquid chromatograph is equipped with a 254-nm detector
.

not more than 8.9 USP Endotoxin Units per mg of


and a 4.6-mm × 25-cm column that contains packing L13. idarubicin hydrochloride, a solution of Idarubicin Hydrochlo-
The flow rate is about 2 mL per minute. Chromatograph the ride for Injection containing 0.07 mg of idarubicin hydro-
Resolution solution, and record the peak responses as di- chloride per mL being used in the Test Procedure.
rected for Procedure: the relative retention times are about
0.5 for 4-demethoxydaunorubicinone and 1.0 for idarubicin;
and the resolution, R, between the 4-demethoxydau- Change to read:
norubicinone peak and the idarubicin peak is not less than
9.5. Chromatograph the Standard preparation, and record •Sterility Tests 〈71〉• (CN 1-May-2016)—It meets the require-
.

the peak responses as directed for Procedure: the capacity ments when tested as directed for Membrane Filtration under
factor, k′, for the idarubicin peak is not less than 10 and not Test for Sterility of the Product to be Examined.
more than 20; the tailing factor for the idarubicin peak is pH 〈791〉: between 5.0 and 7.0, in a solution constituted
not less than 0.85 and not more than 1.2; the column effi- as directed in the labeling, water being used as the diluent.
ciency calculated from the idarubicin peak is not less than
3000 theoretical plates; and the relative standard deviation
for replicate injections is not more than 2.0%. Change to read:
Procedure—Separately inject equal volumes (about 20 µL)
of the Standard preparation and the Assay preparation into •Water Determination, Method I 〈921〉• (CN 1-May-2016):
.

the chromatograph, record the chromatograms, and meas- not more than 4.0%, the Test Preparation being prepared as
ure the areas for the major peaks. Calculate the quantity, in directed for a hygroscopic specimen.
µg, of C26H27NO9 · HCl in each mg of the Idarubicin Hydro-
chloride taken by the formula:
Change to read:
100(C/M)(rU / rS)
Other requirements—It meets the requirements for Uni-
in which C is the concentration, in µg per mL, of idarubicin formity of Dosage Units 〈905〉 and for •Labeling 〈7〉, Labels
.

hydrochloride (C26H27NO9 · HCl) in the Standard preparation; and Labeling for Injectable Products• (CN 1-May-2016).
M is the quantity, in mg, of Idarubicin Hydrochloride taken Assay—
to prepare the Assay preparation; and rU and rS are the re- Mobile phase, Diluent, Standard preparation, Resolution so-
sponses of the idarubicin peak obtained from the Assay lution, and Chromatographic system—Proceed as directed in
preparation and the Standard preparation, respectively. the Assay under Idarubicin Hydrochloride.
Assay preparation—Dilute the contents of 1 container of
Idarubicin Hydrochloride for Injection quantitatively with Dil-
uent to obtain a solution containing about 0.5 mg of

USP Monographs
idarubicin hydrochloride per mL.
Idarubicin Hydrochloride for Injection
.

Procedure—Proceed as directed for Procedure under


Idarubicin Hydrochloride. Calculate the quantity, in mg, of
» Idarubicin Hydrochloride for Injection is a ster- C26H27NO9 · HCl in the container of Idarubicin Hydrochloride
ile mixture of Idarubicin Hydrochloride and Lac- for Injection taken by the formula:
tose. It contains not less than 90.0 percent and (C / 1000)(L / D)(rU / rS)
not more than 110.0 percent of the labeled
amount of C26H27NO9 · HCl. in which C is the concentration, in µg per mL, of idarubicin
Caution—Great care should be taken to prevent hydrochloride (C26H27NO9 · HCl) in the Standard preparation;
inhaling particles of Idarubicin Hydrochloride and L is the labeled quantity, in mg, of idarubicin hydrochloride
in the container; D is the concentration, in mg per mL, of
exposing the skin to it. idarubicin hydrochloride in the Assay preparation on the ba-
sis of the labeled quantity in the container and the extent of
dilution; and rU and rS are the responses of the idarubicin
Change to read: peak obtained from the Assay preparation and the Standard
preparation, respectively.
Packaging and storage—•Preserve as described in Pack-
.

aging and Storage Requirements 〈659〉, Injection Packaging,


Sterile solids packaging• (CN 1-May-2016).
USP Reference standards 〈11〉—
.

USP Endotoxin RS Idarubicin Hydrochloride Injection


USP Idarubicin Hydrochloride RS
DEFINITION
Idarubicin Hydrochloride Injection is a sterile solution in
Change to read: water. It contains NLT 90.0% and NMT 110.0% of the
labeled amount of idarubicin hydrochloride (C26H27NO9 ·
Constituted solution—At the time of use, it meets the HCl).
requirements for •Injections and Implanted Drug Products 〈1〉,
IDENTIFICATION
.

Specific Tests, Completeness and clarity of solutions• (CN 1-May-


2016).
• A. The retention time of the major peak of the Sample
solution corresponds to that of the Standard solution, as
Identification—The chromatogram of the Assay prepara- obtained in the Assay.
tion obtained in the Assay exhibits a major peak for
idarubicin, the retention time of which corresponds to that
in the chromatogram of the Standard preparation obtained
in the Assay.

Official from May 1, 2016


Copyright (c) 2016 The United States Pharmacopeial Convention. All rights reserved.