Description

Methadone Tartrate is the tartrate salt form of the synthetic opioid analgesic, methadone. This high-purity pharmaceutical intermediate is critical for ensuring the consistent quality and efficacy of final drug formulations. It is primarily utilized by manufacturers in the pharmaceutical industry for the production of medication-assisted treatment (MAT) therapies and in controlled clinical research settings.

Application

• Pharmaceutical Active Ingredient (API): Primary use in the formulation of oral solutions, tablets, and dispersible tablets for opioid dependence treatment and chronic pain management.
• Clinical Research & Development: Serves as a key reference standard and intermediate in pharmacokinetic, pharmacodynamic, and metabolic studies.
• Analytical Standard: Used as a certified reference material (CRM) in high-performance liquid chromatography (HPLC), gas chromatography (GC), and mass spectrometry for quality control and forensic analysis.
• Controlled Substance Manufacturing: An essential raw material for licensed producers of Schedule II narcotics under strict regulatory oversight (e.g., DEA, FDA, EMA).

Basic Information

Product Name	Methadone Tartrate
CAS No.	10075-40-8
Molecular Formula	C23H33NO8 • C4H6O6 or C27H39NO14
Molecular Weight	601.60 g/mol
Synonyms	Methadone Bitartrate; (RS)-6-(Dimethylamino)-4,4-diphenylheptan-3-one tartrate; DL-Methadone Tartrate; (±)-Methadone Tartrate; Heptadone Tartrate; Polamidone Tartrate; Phenadone Tartrate; Amidone Tartrate
EINECS	233-230-5

Quality Control

Our Methadone Tartrate is manufactured and tested under strict quality management systems. Each batch is analyzed to meet stringent in-house specifications aligned with pharmaceutical industry expectations for identity, purity, and strength. A comprehensive Certificate of Analysis (COA) detailing results for assay, related substances, residual solvents, and microbiological attributes is provided with every shipment to ensure full traceability and regulatory compliance.

Storage

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

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
Specific Rotation	-0.10° to +0.10° (c=2 in H2O)

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