Description

Amitriptyline n-Glucuronide is a major, pharmacologically relevant metabolite of the tricyclic antidepressant amitriptyline. This compound is critical for pharmaceutical research and development, particularly in the fields of drug metabolism and pharmacokinetics (DMPK). It serves as a vital reference standard for analytical method development, bioanalytical studies, and clinical research. Researchers and quality control laboratories in the pharmaceutical and contract research organization (CRO) sectors require this high-purity metabolite to ensure accurate quantification and understanding of amitriptyline's metabolic profile.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for calibrating analytical instruments and validating methods in drug testing.
• Drug Metabolism and Pharmacokinetics (DMPK) Studies: Essential for investigating the metabolic pathways, clearance rates, and bioavailability of amitriptyline in preclinical and clinical research.
• Bioanalytical Assay Development: Used to develop and validate sensitive HPLC, LC-MS, or LC-MS/MS methods for the quantification of amitriptyline and its metabolites in biological matrices (e.g., plasma, urine).
• Clinical Toxicology and Therapeutic Drug Monitoring (TDM): Aids in accurately measuring metabolite levels to optimize dosage regimens and assess patient adherence or potential toxicity.
• Impurity Profiling: Serves as a known impurity or degradation product standard in the quality control of amitriptyline active pharmaceutical ingredient (API) and finished dosage forms.
• Academic and Institutional Research: Fundamental for studies in neuropharmacology, psychotropic drug research, and forensic toxicology.

Basic Information

Product Name	Amitriptyline n-Glucuronide
CAS No.	112806-33-4
Molecular Formula	C25H31NO7
Molecular Weight	457.52 g/mol
Synonyms	Amitriptyline N-Glucuronide; Amitriptyline Glucuronide; 10,11-Dihydro-N-(3-dimethylaminopropyl)-5H-dibenzo[a,d]cycloheptene-δ5,γ-propylamine Glucuronide; 3-((3-(10,11-Dihydro-5H-dibenzo[a,d][7]annulen-5-ylidene)propyl)dimethylammonio)yl β-D-Glucopyranosiduronate; Amitriptyline Major Metabolite
EINECS	Contact for details

Quality Control

Every batch of our Amitriptyline n-Glucuronide is manufactured and analyzed under strict quality management systems. We provide comprehensive analytical data to support its use as a high-purity reference standard. Our products undergo rigorous quality testing, including identity confirmation, purity assay, and impurity profiling, to ensure compliance with industry standards for research chemicals. A detailed Certificate of Analysis (COA) containing batch-specific results from HPLC, LC-MS, NMR, and other relevant techniques is available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥95.0% (Area Percent)
Purity (LC-MS)	≥95.0%
Water Content (KF)	≤5.0%
Residual Solvents (GC)	Complies with ICH guidelines

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