Description

5-Hydroxymethyl Tolterodine-D14 is a deuterated isotopologue of a key pharmaceutical intermediate, specifically designed for use as an internal standard in quantitative bioanalytical methods. This high-purity compound is essential for ensuring the accuracy and reliability of mass spectrometry analyses, particularly in pharmacokinetic and metabolism studies. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical service providers focused on drug development and regulatory compliance.

Application

• Internal Standard for LC-MS/MS: Critical for the precise quantification of tolterodine and its metabolites in biological matrices such as plasma, serum, and urine.
• Pharmaceutical R&D: Supports drug metabolism and pharmacokinetics (DMPK) studies during the development of tolterodine-based therapies.
• Bioanalytical Method Development: Used to validate and optimize analytical methods for specificity, accuracy, and precision in compliance with FDA and ICH guidelines.
• Clinical Trial Support: Enables reliable monitoring of drug concentration levels in patients during clinical phases.
• Metabolite Identification: Aids in the structural elucidation and tracking of metabolite pathways.
• Quality Control in Manufacturing: Can be employed in analytical labs to ensure the consistency and purity of active pharmaceutical ingredients (APIs).

Basic Information

Product Name	5-Hydroxymethyl Tolterodine-D14
CAS No.	1191280-58-6
Molecular Formula	C22H17D14NO2
Molecular Weight	~351.56 g/mol
Synonyms	5-(Hydroxymethyl)-tolterodine-d14; Deuterated Tolterodine Metabolite; Tolterodine-d14 Hydroxymethyl Derivative; (R)-2-[3-(Bis(1-methylethyl-d7)amino]-1-phenylpropyl]-4-methylphenol-d7 methanol; Isotopically Labeled Tolterodine Intermediate; D14-5-Hydroxymethyltolterodine; Internal Standard for Tolterodine Assay
EINECS	Contact for details

Quality Control

Our 5-Hydroxymethyl Tolterodine-D14 is manufactured under strict quality systems to ensure exceptional isotopic purity and chemical integrity, critical for its role as an analytical standard. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing parameters such as isotopic enrichment (Atom % D), chemical purity (by HPLC), and identity confirmation (by NMR and MS). We adhere to relevant industry standards for reference materials to support GLP/GMP-compliant research.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container should be kept in a desiccated environment to prevent moisture uptake. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (Atom % D)	≥ 98.0%
Water Content (KF)	≤ 0.5%
Residual Solvents (GC)	Complies with ICH limits

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