Description

Tolterodine Impurity 8 is a specified impurity and reference standard used in the quality control of Tolterodine, an active pharmaceutical ingredient (API) for treating overactive bladder. This high-purity compound is critical for pharmaceutical manufacturers to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying related substances. It is essential for R&D laboratories, quality assurance/quality control (QA/QC) units, and analytical testing facilities involved in the development and production of Tolterodine and its formulations.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Tolterodine API and finished dosage forms.
• Method Development & Validation: Critical for developing, optimizing, and validating analytical methods, particularly HPLC and UPLC, in compliance with ICH guidelines.
• Quality Control & Batch Release: Used in routine QC testing to monitor impurity profiles and ensure batches meet stringent pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Employed to track the formation of degradation products in Tolterodine formulations under various stress conditions.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Synthesis: Serves as a key intermediate or marker for researchers studying the metabolism, synthesis pathways, or degradation mechanisms of Tolterodine.

Basic Information

Product Name	Tolterodine Impurity 8
CAS No.	194482-41-2
Molecular Formula	C22H31NO
Molecular Weight	325.49 g/mol
Synonyms	(R)-N,N-Diisopropyl-3-(2-hydroxy-5-methylphenyl)-3-phenylpropanamine; (R)-2-[3-(Diisopropylamino)-1-phenylpropyl]-4-methylphenol; Tolterodine Related Compound B; Tolterodine EP Impurity B; Tolterodine USP Impurity; Tolterodine Isomer; (R)-Tolterodine Alcohol Impurity
EINECS	Contact for details

Quality Control

Every batch of Tolterodine Impurity 8 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Our quality system is designed to meet the exacting standards of the pharmaceutical industry. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for assay, related substances, residual solvents, and other critical parameters as per ICH Q3A/B guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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