Description

Amitriptyline Metabolite (+/-)- is a key reference standard and analytical intermediate of significant importance in pharmaceutical research and development. This compound is critical for the accurate quantification and metabolic profiling of the widely used tricyclic antidepressant, Amitriptyline. It is primarily utilized by analytical laboratories, pharmaceutical manufacturers, and contract research organizations (CROs) engaged in drug metabolism studies, bioanalytical method development, and quality control of active pharmaceutical ingredients (APIs).

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the calibration of analytical instruments and validation of testing methods in compliance with ICH and GMP guidelines.
• Metabolite Identification & Profiling: Essential for in vitro and in vivo studies to identify, quantify, and understand the pharmacokinetic behavior of Amitriptyline metabolites.
• Bioanalytical Method Development: Serves as a critical standard for developing and optimizing HPLC, LC-MS, and GC-MS assays for biological matrices (plasma, urine).
• Impurity Characterization: Employed in the identification and control of process-related impurities and degradation products in Amitriptyline API manufacturing.
• Clinical & Forensic Toxicology: Used as a calibrant in assays designed for therapeutic drug monitoring (TDM) and forensic analysis.
• Pharmacology Research: Aids in studying the activity, toxicity, and disposition of Amitriptyline and its metabolic pathways.

Basic Information

Product Name	Amitriptyline Metabolite (+/-)-
CAS No.	72402-20-1
Molecular Formula	C20H23N
Molecular Weight	277.41 g/mol
Synonyms	10,11-Dihydro-N,N-dimethyl-5H-dibenzo[a,d]cycloheptene-δ5(6),γ-propylamine; Nortriptyline Impurity; Amitriptyline Related Compound; 3-(10,11-Dihydro-5H-dibenzo[a,d]cyclohepten-5-ylidene)-N,N-dimethyl-1-propanamine; Desmethylnortriptyline; Didesmethylamitriptyline
EINECS	Contact for details

Quality Control

Our Amitriptyline Metabolite (+/-)- is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identity confirmation by spectroscopic methods (IR, NMR), purity assessment by HPLC, and determination of residual solvents. We provide full traceability and Certificates of Analysis (COA) are supplied with every shipment, detailing all critical quality attributes. Our quality standards align with the requirements for pharmaceutical reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere at -20°C.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0%
Water Content (KF)	≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C

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