Description

Fesoterodine Related Impurity 4 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient Fesoterodine fumarate. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The availability of this well-characterized impurity standard is essential for maintaining stringent quality control in drug production.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quality control and release testing of Fesoterodine fumarate API and finished dosage forms.
• Analytical Method Development & Validation: Used in HPLC, UPLC, and LC-MS methods to establish specificity, accuracy, and detection limits for impurity quantification.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submissions (e.g., for FDA, EMA) that require detailed impurity identification and characterization reports.
• Stability Studies: Employed to monitor and quantify the formation of this specific impurity in Fesoterodine formulations under various stress and shelf-life conditions.
• Research & Development: Used in synthetic chemistry R&D to study the formation pathway and develop processes to minimize this impurity.
• Pharmacopoeial Testing: Supports testing in compliance with pharmacopoeial monographs (e.g., USP, EP) that specify limits for known and unknown impurities.

Basic Information

Product Name	Fesoterodine Related Impurity 4
CAS No.	214601-12-4
Molecular Formula	C26H37NO3
Molecular Weight	411.58 g/mol
Synonyms	Fesoterodine Impurity 4; (R)-2-(3-(Diisopropylamino)-1-phenylpropyl)-4-(hydroxymethyl)phenyl isobutyrate; 4-Hydroxymethyl Tolterodine; Fesoterodine EP Impurity D; Fesoterodine USP Related Compound D; Tolterodine Related Compound; (R)-Tolterodine alcohol isobutyrate ester; Contact for additional synonyms.
EINECS	Contact for details

Quality Control

Every batch of Fesoterodine Related Impurity 4 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assessment, and impurity profiling using advanced analytical techniques such as HPLC, GC, NMR, and MS. Our quality commitment ensures compliance with relevant standards for pharmaceutical reference materials. 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. For long-term storage, consider storing under inert atmosphere at -20°C to ensure maximum stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w

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