Description

Rac Tolterodine-D14 Hydrochloride is a high-purity, isotopically labeled internal standard critical for precise quantitative analysis in bioanalytical and pharmacokinetic studies. This deuterated compound is essential for ensuring analytical accuracy and reliability in method development and validation. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical service providers engaged in drug metabolism and mass spectrometry-based assays.

Application

• Internal Standard for LC-MS/MS: Serves as a critical reference compound for the accurate quantification of Tolterodine and its metabolites in complex biological matrices like plasma, serum, and urine.
• Pharmacokinetic/Pharmacodynamic (PK/PD) Studies: Enables precise tracking of drug absorption, distribution, metabolism, and excretion (ADME) in preclinical and clinical research.
• Bioanalytical Method Development & Validation: Used to establish and validate robust, sensitive, and specific analytical methods compliant with FDA, EMA, and ICH guidelines.
• Drug Metabolism Studies: Facilitates the identification and quantification of metabolite profiles, aiding in understanding the metabolic pathways of Tolterodine.
• Quality Control in Reference Material Production: Acts as a calibrant or system suitability standard in the manufacturing of certified reference materials (CRMs).
• Forensic and Doping Control Analysis: Supports accurate detection and quantification in specialized testing environments requiring high specificity.

Basic Information

Product Name	Rac Tolterodine-D14 Hydrochloride
CAS No.	1246816-99-8
Molecular Formula	C22H17D14NO2•HCl
Molecular Weight	~428.0 g/mol (for deuterated form)
Synonyms	(±)-2-[(1R)-3-[Bis(1-methylethyl)amino]-1-phenylpropyl]-4-methylphenol-d14 Hydrochloride; Tolterodine-d14 HCl; rac-Tolterodine-d14 Hydrochloride; Tolterodine (phenyl-d5, isopropyl-d7) Hydrochloride; Isotopically Labeled Tolterodine Hydrochloride; Deuterated Tolterodine Internal Standard; DL-Tolterodine-d14 Hydrochloride
EINECS	Contact for details

Quality Control

Every batch of Rac Tolterodine-D14 Hydrochloride is manufactured and analyzed under strict quality systems. We ensure compliance with the high standards required for analytical reference materials, with a focus on isotopic purity, chemical purity, and stability. Comprehensive Certificates of Analysis (COA) are provided, detailing results from NMR (for deuterium incorporation), HPLC/LC-MS (for chemical and isomeric purity), and residual solvent analysis. Our quality commitment supports your compliance with GLP and regulatory submission requirements.

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 product is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccant use and storage under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to expected mass spectrum
Purity (HPLC)	≥98.0% (Chemical Purity)
Isotopic Purity (Deuterium Incorporation)	≥98.0 atom % D (by NMR or MS)
Water Content (KF)	≤1.0%
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.