Description

Fesoterodine Related Impurity 2 is a high-purity chemical reference standard used in the pharmaceutical development and manufacturing process. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Fesoterodine fumarate. It serves as a key analytical marker for identification and quantification during impurity profiling and method validation. Pharmaceutical manufacturers, analytical laboratories, and quality control departments require this standard to meet stringent pharmacopeial guidelines and ensure batch-to-batch consistency.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Fesoterodine fumarate API and finished dosage forms.
• Analytical Method Development and Validation: Essential for developing, optimizing, and validating chromatographic methods (HPLC, UPLC) to ensure accurate impurity detection.
• Quality Control and Assurance (QC/QA): Employed in routine batch release testing to monitor impurity levels and ensure compliance with ICH Q3A/B guidelines and pharmacopeial monographs (USP, EP).
• Stability Studies: Acts as a reference standard in forced degradation and long-term stability studies to track impurity formation over time.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research and Development (R&D): Used in synthetic chemistry research to understand degradation pathways and optimize the API synthesis process to minimize this impurity.

Basic Information

Product Name	Fesoterodine Related Impurity 2
CAS No.	1254942-29-4
Molecular Formula	C26H37NO3
Molecular Weight	411.58 g/mol
Synonyms	Fesoterodine Impurity 2; (R)-2-(3-(Diisopropylamino)-1-phenylpropyl)-4-(hydroxymethyl)phenol; Fesoterodine EP Impurity B; Fesoterodine USP Related Compound B; Fesoterodine Process Impurity; 4-(Hydroxymethyl)-2-[(1R)-3-(diisopropylamino)-1-phenylpropyl]phenol; Fesoterodine Related Compound 2
EINECS	Contact for details

Quality Control

Every batch of Fesoterodine Related Impurity 2 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards. Comprehensive characterization is performed using advanced analytical techniques including HPLC, GC, NMR, and MS to confirm identity and purity. Certificates of Analysis (COA) are available upon request, providing full traceability and batch-specific data.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is hygroscopic (moisture-sensitive); ensure the container is sealed after each use to prevent absorption of moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
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% w/w

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