Description

Methadone Hydrobromide is a pharmaceutically active salt form of the synthetic opioid analgesic, methadone. This compound is critical for its role in controlled pain management and as a cornerstone in medication-assisted treatment (MAT) programs for opioid dependence. It is primarily utilized by pharmaceutical manufacturers, research institutions, and compounding pharmacies requiring a high-purity active pharmaceutical ingredient (API).

Application

• Active Pharmaceutical Ingredient (API): Core component in the formulation of prescription medications for severe pain management.
• Opioid Agonist Therapy (OAT): Essential for manufacturing medications used in the treatment of opioid use disorder, aiding in withdrawal management and maintenance therapy.
• Pharmaceutical Research & Development: Used in preclinical and clinical studies for developing new analgesic formulations or delivery systems.
• Reference Standard: Serves as a high-purity calibrant in analytical laboratories for quality control and forensic analysis.
• Compounding Pharmacy: Employed by specialized pharmacies to prepare customized dosage forms as per physician prescriptions.

Basic Information

Product Name	Methadone Hydrobromide
CAS No.	19767-48-7
Molecular Formula	C21H27NO • HBr
Molecular Weight	390.36 g/mol
Synonyms	Methadone HBr; Methadone Hydrobromide Salt; (RS)-6-(Dimethylamino)-4,4-diphenylheptan-3-one hydrobromide; DL-Methadone Hydrobromide; Amidone Hydrobromide; Phenadone Hydrobromide; Heptanal, 6-(dimethylamino)-4,4-diphenyl-, hydrobromide
EINECS	Contact for details

Quality Control

Our Methadone Hydrobromide is manufactured and tested under strict quality management systems. We ensure compliance with current Good Manufacturing Practices (cGMP) and relevant pharmacopeial standards (e.g., USP, EP) where applicable. Certificates of Analysis (COA) documenting identity, purity, and impurity profiles are provided with each batch to guarantee traceability and regulatory support.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.5%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.