Description

Fesoterodine Impurity 8 is a specified impurity and degradation product of the active pharmaceutical ingredient Fesoterodine Fumarate. This compound is critical for pharmaceutical research and development, serving as a key reference standard in analytical method development and quality control processes. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Fesoterodine-based drug products.

Application

• Primary use as a Pharmaceutical Reference Standard for the identification and quantification of impurities in Fesoterodine Fumarate API and finished dosage forms.
• Critical component in Analytical Method Development and Validation (HPLC, UPLC, GC) for stability-indicating assays.
• Essential for conducting Stability Studies and forced degradation studies to understand the degradation pathways of Fesoterodine.
• Used in Quality Control (QC) and Quality Assurance (QA) laboratories to monitor batch-to-batch consistency and compliance with ICH guidelines.
• Serves as a Research Chemical for studying the metabolism and pharmacokinetics of Fesoterodine.
• Supports regulatory submissions (e.g., ANDA, NDA) by providing necessary impurity profile data to agencies like the FDA and EMA.

Basic Information

Product Name	Fesoterodine Impurity 8
CAS No.	1380491-71-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Fesoterodine Related Compound 8; Fesoterodine Fumarate Impurity 8; Fesoterodine Degradation Product; (R)-2-(3-(Diisopropylamino)-1-phenylpropyl)-4-(hydroxymethyl)phenol; Toviaz Impurity 8
EINECS	Contact for details

Quality Control

Every batch of Fesoterodine Impurity 8 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC purity analysis and structural confirmation (NMR, MS), to ensure compliance with pharmacopeial standards and customer-specific requirements. A comprehensive Certificate of Analysis (COA) detailing identity, purity, and chromatographic data is provided with each shipment and is available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 3.0%
Water Content (KF)	≤ 5.0%

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