Idarubicin Hydrochloride Injection

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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1 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).

2 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.

3 ASSAY

Procedure

Solution A:

2.9 g/L of sodium lauryl sulfate in water. To each liter of this solution add 1.3 mL of phosphoric acid.

Mobile phase:

Acetonitrile and Solution A (1:1)

Standard solution:

0.04 mg/mL of USP Idarubicin Hydrochloride RS in water

Sample solution:

Nominally 0.04 mg/mL of idarubicin hydrochloride in water

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 254 nm

Column: 4.6-mm × 50-mm; 5-µm packing L7

Column temperature: 40°

Flow rate: 1.5 mL/min

Injection volume: 10 µL

System suitability

Sample: Standard solution

Suitability requirements

Tailing factor: NMT 2.0

Relative standard deviation: NMT 2.0%

Analysis

Samples: Standard solution and Sample solution

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: 90.0%–110.0%

4 IMPURITIES

Organic Impurities

Solution A:

2.9 g/L of sodium lauryl sulfate and 2.3 g/L of phosphoric acid in water

Mobile phase:

Tetrahydrofuran, methanol, and Solution A (25:15:60)

Diluent A:

2.3 g/L of phosphoric acid in water

Diluent B:

Tetrahydrofuran, methanol, and Diluent A (25:15:60). Adjust with 2 N sodium hydroxide to a pH of 3.6.

Standard solution:

0.01 mg/mL of USP Idarubicin Hydrochloride RS in Diluent B

Sample solution:

Nominally 0.5 mg/mL of idarubicin hydrochloride in Diluent B

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 254

Column: 4.6-mm × 25-cm; 5-µm packing L7

Column temperature: 40°

Flow rate: 1.5 mL/min

Injection volume: 20 µL

System suitability

Sample: Standard solution

Suitability requirements

Relative standard deviation: NMT 5.0%

Analysis

Samples: Standard solution and Sample solution

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: See Table 1. The reporting threshold is 0.04%.

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.

5 SPECIFIC TESTS

Bacterial Endotoxins Test 〈85〉: Contains NMT 8.9 USP Endotoxin Units/mg of idarubicin hydrochloride

Sterility Tests 〈71〉, Test for Sterility of the Product to Be Examined, Membrane Filtration: Meets the requirements

pH 〈791〉: 3.0–4.5

Particulate Matter in Injections 〈788〉: Meets the requirements for small-volume injections

6 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in tight containers as described in Packaging and Storage Requirements 〈659〉, Injection Packaging, Packaging for constitution. Store at 2°–8°, protected from light.

Labeling: Meets the requirements in Labeling 〈7〉, Labels and Labeling for Injectable Products

USP Reference Standards 〈11〉

USP Idarubicin Hydrochloride RS