Description

Fesoterodine Impurity 6 is a high-purity reference standard used in the pharmaceutical development and quality control of Fesoterodine fumarate, an antimuscarinic agent. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API) by serving as a benchmark in analytical testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Fesoterodine fumarate API and finished dosage forms.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing, validating, and verifying chromatographic methods to monitor impurity levels throughout the drug manufacturing process.
• Stability Indicating Studies: Employed in forced degradation and long-term stability studies to track the formation of this specific impurity under various stress conditions.
• Quality Control & Batch Release Testing: A critical component in the routine QC testing of Fesoterodine batches to ensure they meet stringent pharmacopeial (e.g., USP, EP) and ICH guidelines for impurity limits.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing characterized impurity data.
• Research & Development: Used in synthetic chemistry R&D to understand and control the formation pathways of this impurity during the API synthesis.

Basic Information

Product Name	Fesoterodine Impurity 6
CAS No.	1333234-71-1
Molecular Formula	C26H37NO3
Molecular Weight	411.58 g/mol
Synonyms	Fesoterodine Related Compound 6; Fesoterodine Fumarate Impurity 6; (R)-2-(3-(Diisopropylamino)-1-phenylpropyl)-4-(hydroxymethyl)phenol; 4-(Hydroxymethyl)-α-[(R)-3-(N,N-diisopropylamino)-1-phenylpropyl]phenol; Toviaz Impurity 6
EINECS	Contact for details

Quality Control

Every batch of Fesoterodine Impurity 6 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed to prevent absorption of atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 0.5% Total impurities ≤ 1.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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