Methadone Hydrochloride
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This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
C21H27NO.HCl 345.91
3-Heptanone, 6-(dimethylamino)-4,4-diphenyl-, hydrochloride;
6-(Dimethylamino)-4,4-diphenyl-3-heptanone hydrochloride CAS RN®: 1095-90-5; UNII: 229809935B.
1 DEFINITION
Methadone Hydrochloride contains NLT 98.5% and NMT 100.5% of methadone hydrochloride (C21H27NO.HCl), calculated on the dried basis.
2 IDENTIFICATION
Change to read:
Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197K (CN 1-May-2020)
Identification Tests—General, Chloride〈191〉: A solution meets the requirements of the tests.
3 ASSAY
Procedure
Sample: 500 mg
Mode: Direct titration
Titrimetric system
Titrant: 0.1 N perchloric acid VS
Endpoint detection: Visual
Analysis: Dissolve the Sample in a mixture of 10 mL of glacial acetic acid and 10 mL of mercuric acetate TS, warming slightly if necessary to dissolve. Cool the solution to room temperature, add 10 mL of dioxane, then add crystal violet TS, and titrate rapidly with Titrant. Perform a blank determination, and make any necessary correction (see Titrimetry 〈541〉). Each mL of Titrant is equivalent to 34.59 mg of methadone hydrochloride (C21H27NO.HCl).
Acceptance criteria: 98.5%–100.5% on the dried basis
4 IMPURITIES
Residue on Ignition 〈281〉: NMT 0.1%
Ordinary Impurities 〈466〉
Standard solution: Alcohol
Sample solution: Alcohol
Eluant: Methanol and ammonium hydroxide (100:1.5)
Visualization: 3
Acceptance criteria: The sum of the intensities of all secondary spots from the Sample solution corresponds to NMT 1.0%.
5 SPECIFIC TESTS
pH 〈791〉
Sample solution: 10 mg/mL
Acceptance criteria: 4.5–6.5
Loss on Drying 〈731〉
Sample: 500 mg
Analysis: Dry the Sample at 105° for 1 h.
Acceptance criteria: NMT 0.3%
6 ADDITIONAL REQUIREMENTS
Packaging and Storage: Preserve in tight, light-resistant containers. Store at 25°, excursions permitted between 15° and 30°.
USP Reference Standards 〈11〉
USP Methadone Hydrochloride RS
