Mitotane

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

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

DOWNLOAD PDF HERE

C₁₄H₁₀Cl₄              320.04

Benzene, 1-chloro-2-[2,2-dichloro-1-(4-chlorophenyl)ethyl]-, (RS)-; (±)-1,1-Dichloro-2-(o-chlorophenyl)-2-(p-chlorophenyl)ethane CAS RN: 53-19-0; UNII: 78E4J5IB5J.

1 DEFINITION

Mitotane contains NLT 97.0% and NMT 103.0% of mitotane (CHCI), calculated on the anhydrous basis.

[CAUTION-Handle Mitotane with exceptional care, because it is a highly potent agent.]

2 IDENTIFICATION

Change to read:

A. SPECTROSCOPIC IDENTIFICATION TESTS (197), Infrared Spectroscopy: 197M or 197A _{(RB 1-Aug-2023)}

B. 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

Change to read:

PROCEDURE

Buffer: 1.38 g/L of monobasic potassium phosphate in water. Adjust with phosphoric acid to a pH of 2.5.

Mobile phase: Acetonitrile and Buffer (75:25)

System suitability solution: 0.2 mg/ml. of USP Mitotane RS and 0.2 mg/mL of USP Mitotane Related Compound A RS in Mobile phase _{(RB 1-Aug-2023)}

Standard solution: 0.2 mg/mL of USP Mitotane RS in Mobile phase

Sample solution: 0.2 mg/mL of Mitotane in Mobile phase. [NOTE-Inject within 48 h of preparation.]

Chromatographic system

(See Chromatography (621) System Suitability.)

Mode: LC

Detector: UV 230 nm

Column: 4.6-mm x 25-cm; 5-µm packing L1

Flow rate: 1 mL/min

Injection volume: 10 µL

System suitability

Samples: System suitability solution and Standard solution

[NOTE-The relative retention times for mitotane related compound A _{(RB 1-Aug-2023)} and mitotane are about 0.92 and 1.0, respectively.]

Suitability requirements

Resolution: NLT 1.5 between mitotane related compound A _{(RB 1-Aug-2023)} and mitotane, System suitability solution

Tailing factor: NMT 1.5, Standard solution

Relative standard deviation: NMT 1.0%, Standard solution

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of mitotane (C₁₄H₁₀Cl₄) in the portion of Mitotane taken:

Result = (r_u /r_s ) × (C_s /C_u ) × 100

r_u = peak response of mitotane from the Sample solution

r_s = peak response of mitotane from the Standard solution

C_s = concentration of USP Mitotane RS in the Standard solution (mg/mL)

C_u = concentration of Mitotane in the Sample solution (mg/mL)

Acceptance criteria: 97.0%–103.0% on the anhydrous basis

4 IMPURITIES

RESIDUE ON IGNITION (281): NMT 0.5%

Delete the following:

ORGANIC IMPURITIES (RB 1-Aug-2023)

5 SPECIFIC TESTS

WATER DETERMINATION (921), Method / Method la: NMT 0.5%

6 ADDITIONAL REQUIREMENTS

Change to read:

PACKAGING AND STORAGE: Preserve in tight, light-resistant containers. Store at room temperature _{(RB 1-Aug-2023)}

Change to read:

USP REFERENCE STANDARDS (11)

USP Mitotane RS

USP Mitotane Related Compound A RS

2,2-Bis(4-Chlorophenyl)-1,1-dichloroethane.

C₁₄H₁₀Cl₄             320.04 (RB 1-Aug-2023)