Add the following:
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.
ASSAY
• Procedure
Solution A:
Mobile phase:
Standard solution:
Sample solution:
Chromatographic system
Mode:
Detector:
Column:
Column temperature:
Flow rate:
Injection volume:
System suitability
Sample:
Suitability requirements
Tailing factor:
Relative standard deviation:
Analysis
Samples:
Calculate the percentage of the labeled amount of idarubicin hydrochloride (C26H27NO9·HCl) in the portion of Injection taken:
Result = (rU/rS) × (CS/CU) × P × F × 100
| rU | = | = peak response from the Sample solution |
| rS | = | = peak response from the Standard solution |
| CS | = | = concentration of USP Idarubicin Hydrochloride RS in the Standard solution (mg/mL) |
| CU | = | = nominal concentration of idarubicin hydrochloride in the Sample solution (mg/mL) |
| P | = | = potency of USP Idarubicin Hydrochloride RS (µg/mg) |
| F | = | = conversion factor, 0.001 mg/µg |
Acceptance criteria:
IMPURITIES
• Organic Impurities
Solution A:
Mobile phase:
Diluent A:
Diluent B:
Standard solution:
Sample solution:
Chromatographic system
Mode:
Detector:
Column:
Column temperature:
Flow rate:
Injection volume:
System suitability
Sample:
Suitability requirements
Relative standard deviation:
Analysis
Samples:
Calculate the percentage of each individual impurity in the portion of Injection taken:
Result = (rU/rS) × (CS/CU) × P × F1 × (1/F2) × 100
| rU | = | = peak response of each individual impurity from the Sample solution |
| rS | = | = peak response of idarubicin from the Standard solution |
| CS | = | = concentration of USP Idarubicin Hydrochloride RS in the Standard solution (mg/mL) |
| CU | = | = nominal concentration of idarubicin hydrochloride in the Sample solution (mg/mL) |
| P | = | = potency of USP Idarubicin Hydrochloride RS (µg/mg) |
| F1 | = | = conversion factor, 0.001 mg/µg |
| F2 | = | = relative response factor (see Table 1) |
Acceptance criteria:
Table 1
| Name |
Relative Retention Time |
Relative Response Factor |
Acceptance Criteria, NMT (%) |
|---|---|---|---|
| Idarubicin aglyconea |
0.3 |
1.5 |
2.5 |
| Dianhydro idarubicin aglyconeb |
0.9 |
1.3 |
0.5 |
| Idarubicin hydrochloride |
1.0 |
— |
— |
| Any other individual impurity |
— |
1.0 |
0.5 |
| Total impurities |
— |
— |
3.5 |
|
a
(7S,9S)-9-Acetyl-6,7,9,11-tetrahydroxy-7,8,9,10-tetrahydrotetracene-5,12-dione.
b
8-Acetyl-6,11-dihydroxynaphthacene-5,12-dione.
|
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SPECIFIC TESTS
• Bacterial Endotoxins Test 
85
:
85:
• Sterility Tests 71:
71:
• pH 791:
791:
• Particulate Matter in Injections 788:
788:
• Constituted Solution:
1, Constituted Solutions.
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
1, Containers for Sterile Solids. Store at 2–8, protected from light.
• Labeling:
1, Labeling
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USP38
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Ahalya Wise, M.S.
Senior Scientific Liaison (301) 816-8161 |
(SM12010) Monographs - Small Molecules 1 |
| 85 |
Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison (301) 816-8339 |
(GCM2010) General Chapters - Microbiology |
| 71 |
Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison (301) 816-8339 |
(GCM2010) General Chapters - Microbiology |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP38–NF33 Page 3834
Pharmacopeial Forum: Volume No. 39(6)