Accessed from 10.6.1.
1 by merck1 on Sat Jun 04 12:52:41 EDT 2016
USP 39
solution contains a mixture of 4-demethoxydaunorubicinone
and idarubicin.
Chromatographic system (see Chromatography 〈621〉)—The
liquid chromatograph is equipped with a 254-nm detector
and a 4.6-mm × 25-cm column that contains packing L13.
The flow rate is about 2 mL per minute. Chromatograph the
Resolution solution, and record the peak responses as di-
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-
norubicinone peak and the idarubicin peak is not less than
9.5. Chromatograph the Standard preparation, and record
the peak responses as directed for Procedure: the capacity
factor, k′, for the idarubicin peak is not less than 10 and not
more than 20; the tailing factor for the idarubicin peak is
not less than 0.85 and not more than 1.2; the column effi-
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%.
Procedure—Separately inject equal volumes (about 20 µL)
of the Standard preparation and the Assay preparation into
the chromatograph, record the chromatograms, and meas-
ure the areas for the major peaks. Calculate the quantity, in
µg, of C26H27NO9 · HCl in each mg of the Idarubicin Hydro-
chloride taken by the formula:
100(C/M)(rU / rS)
in which C is the concentration, in µg per mL, of idarubicin
hydrochloride (C26H27NO9 · HCl) in the Standard preparation;
M is the quantity, in mg, of Idarubicin Hydrochloride taken
to prepare the Assay preparation; and rU and rS are the re-
sponses of the idarubicin peak obtained from the Assay
preparation and the Standard preparation, respectively.
Idarubicin Hydrochloride for Injection
.
» Idarubicin Hydrochloride for Injection is a ster-
ile mixture of Idarubicin Hydrochloride and Lac-
tose. It contains not less than 90.0 percent and
not more than 110.0 percent of the labeled
amount of C26H27NO9 · HCl.
Caution—Great care should be taken to prevent
inhaling particles of Idarubicin Hydrochloride and
exposing the skin to it.
Change to read:
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
USP Idarubicin Hydrochloride RS
Change to read:
Constituted solution—At the time of use, it meets the
requirements for •Injections and Implanted Drug Products 〈1〉,
.
Specific Tests, Completeness and clarity of solutions• (CN 1-May-
2016).
Identification—The chromatogram of the Assay prepara-
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.
Official Monographs / Idarubicin 4275
Change to read:
•Bacterial Endotoxins Test 〈85〉• (CN 1-May-2016)—It contains
.
not more than 8.9 USP Endotoxin Units per mg of
idarubicin hydrochloride, a solution of Idarubicin Hydrochlo-
ride for Injection containing 0.07 mg of idarubicin hydro-
chloride per mL being used in the Test Procedure.
Change to read:
•Sterility Tests 〈71〉• (CN 1-May-2016)—It meets the require-
.
ments when tested as directed for Membrane Filtration under
Test for Sterility of the Product to be Examined.
pH 〈791〉: between 5.0 and 7.0, in a solution constituted
as directed in the labeling, water being used as the diluent.
Change to read:
•Water Determination, Method I 〈921〉• (CN 1-May-2016):
.
not more than 4.0%, the Test Preparation being prepared as
directed for a hygroscopic specimen.
Change to read:
Other requirements—It meets the requirements for Uni-
formity of Dosage Units 〈905〉 and for •Labeling 〈7〉, Labels
.
and Labeling for Injectable Products• (CN 1-May-2016).
Assay—
Mobile phase, Diluent, Standard preparation, Resolution so-
lution, and Chromatographic system—Proceed as directed in
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.
Procedure—Proceed as directed for Procedure under
Idarubicin Hydrochloride. Calculate the quantity, in mg, of
C26H27NO9 · HCl in the container of Idarubicin Hydrochloride
for Injection taken by the formula:
(C / 1000)(L / D)(rU / rS)
in which C is the concentration, in µg per mL, of idarubicin
hydrochloride (C26H27NO9 · HCl) in the Standard preparation;
L is the labeled quantity, in mg, of idarubicin hydrochloride
in the container; D is the concentration, in mg per mL, of
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
peak obtained from the Assay preparation and the Standard
preparation, respectively.
.
Idarubicin Hydrochloride Injection
DEFINITION
Idarubicin Hydrochloride Injection is a sterile solution in
water. It contains NLT 90.0% and NMT 110.0% of the
labeled amount of idarubicin hydrochloride (C26H27NO9 ·
HCl).
IDENTIFICATION
• A. The retention time of the major peak of the Sample
solution corresponds to that of the Standard solution, as
obtained in the Assay.