Description

Tolterodine Dimer Impurity is a high-purity reference standard critical for analytical method development and validation in pharmaceutical quality control. This compound is essential for accurately identifying and quantifying the dimeric impurity during the manufacturing and stability testing of Tolterodine, an active pharmaceutical ingredient used in urological treatments. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory affairs professionals to ensure drug safety, efficacy, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the quantitative and qualitative analysis of Tolterodine and its related substances.
• Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to monitor impurities in Tolterodine API and finished dosage forms.
• Quality Control & Assurance: Employed in routine QC testing to ensure Tolterodine batches meet specified impurity limits as per ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Used to track the formation of degradation products in Tolterodine formulations under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate control over impurities.
• Research & Development: Serves as a key impurity standard in synthetic chemistry R&D to optimize Tolterodine manufacturing processes and reduce impurity formation.

Basic Information

Product Name	Tolterodine Dimer Impurity
CAS No.	854306-72-2
Molecular Formula	C52H74N2O4
Molecular Weight	791.2 g/mol
Synonyms	(R)-N,N-Diisopropyl-3-(2-hydroxy-5-methylphenyl)-3-phenylpropanamine Dimer; Tolterodine Dimer; Tolterodine Dimer Related Compound; Tolterodine Impurity Dimer; (R)-2-[3-(Diisopropylamino)-1-phenylpropyl]-4-methylphenol Dimer; Dimeric Impurity of Tolterodine; 1,1'-(2,2'-(Phenylazanediyl)bis(ethane-2,1-diyl))bis(N,N-diisopropyl-3-(2-hydroxy-5-methylphenyl)-3-phenylpropan-1-amine) (IUPAC-like)
EINECS	Contact for details

Quality Control

Our Tolterodine Dimer Impurity is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from multiple orthogonal techniques, including HPLC, NMR, and MS. The quality management adheres to cGMP principles and is designed to support regulatory requirements for pharmaceutical impurities as outlined in ICH Q7 and relevant pharmacopeias (USP, EP).

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Assay	90.0% - 110.0% (on dried basis)
Water Content (KF)	≤ 5.0%
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.