Description

Amitriptyline Triisopropyl-n-β-D-Glucuronide Methyl Ester Trifluoromethanesulfonate is a high-purity, synthetically derived reference standard and advanced pharmaceutical intermediate. This compound is critical for analytical method development, validation, and quality control in pharmaceutical research and manufacturing. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and manufacturers of active pharmaceutical ingredients (APIs) involved in the development and production of tricyclic antidepressant drugs and their metabolites.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the quantitative and qualitative analysis of amitriptyline metabolites in bioanalytical studies, pharmacokinetic research, and clinical trials.
• Metabolite Synthesis & Research: Serves as a key synthetic intermediate in the preparation of glucuronidated metabolites for studying drug metabolism, pharmacokinetics (PK), and pharmacodynamics (PD).
• Analytical Method Development: Essential for developing and validating high-performance liquid chromatography (HPLC), liquid chromatography-mass spectrometry (LC-MS), and other analytical methods in compliance with ICH and GLP guidelines.
• Impurity Profiling: Employed to identify, characterize, and quantify process-related impurities and degradation products in amitriptyline-based drug substances and finished products.
• Regulatory Submissions: Provides critical data for regulatory filings (e.g., with the FDA, EMA) to demonstrate comprehensive understanding of a drug's metabolic pathway and impurity profile.
• Stability Studies: Used as a marker compound in forced degradation and long-term stability studies to assess drug product shelf-life and storage conditions.

Basic Information

Product Name	Amitriptyline Triisopropyl-n-β-D-Glucuronide Methyl Ester Trifluoromethanesulfonate
CAS No.	1207167-94-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Amitriptyline Triisopropyl Glucuronide Methyl Ester Triflate; Amitriptyline Glucuronide Methyl Ester Triisopropyl Derivative Trifluoromethanesulfonate; 3-((2-((3-(10,11-Dihydro-5H-dibenzo[a,d][7]annulen-5-ylidene)-1-methylpropyl)amino)ethyl)amino)-3-oxopropyl 2,3,4-tri-O-isopropyl-1-(methoxycarbonyl)-β-D-glucopyranuronate Trifluoromethanesulfonate; ATG Methyl Ester Triisopropyl Triflate; Amitriptyline Metabolite Glucuronide Ester
EINECS	Contact for details

Quality Control

Our Amitriptyline Triisopropyl-n-β-D-Glucuronide Methyl Ester Trifluoromethanesulfonate is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity, LC-MS for identity confirmation, and NMR for structural verification, to ensure it meets the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing identity, purity, and assay is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a freezer. This product is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability and purity. Allow the sealed container to reach room temperature before opening to prevent condensation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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