Description

Fesoterodine Impurity 5 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient, Fesoterodine Fumarate. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a reference marker in chromatographic methods. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, development, and quality assurance processes.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Fesoterodine Impurity 5 in Fesoterodine Fumarate drug substance and finished dosage forms.
• Method Development and Validation: Essential for developing, optimizing, and validating stability-indicating HPLC/UPLC methods in accordance with ICH guidelines.
• Quality Control (QC) Testing: Employed in routine batch release testing to monitor impurity levels and ensure compliance with regulatory specifications (e.g., ICH Q3A(R2), Q3B(R2)).
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions: Provides necessary impurity characterization data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs).
• Pharmacopoeial Analysis: Supports testing to meet the monograph requirements of major pharmacopoeias such as USP, EP, and BP.

Basic Information

Product Name	Fesoterodine Impurity 5
CAS No.	1262778-55-1
Molecular Formula	C26H37NO4
Molecular Weight	427.58 g/mol
Synonyms	Fesoterodine Related Compound 5; (2R,3R)-2,3-Dihydroxy-2-(3-(diisopropylamino)-1-phenylpropyl)succinic acid; Fesoterodine Diacid Impurity; Fesoterodine Acid Impurity; (2R,3R)-2,3-Dihydroxy-2-[3-(diisopropylamino)-1-phenylpropyl]butanedioic acid; Fesoterodine Impurity D (Potential); Toviaz Impurity 5
EINECS	Contact for details

Quality Control

Our Fesoterodine Impurity 5 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical characterization using techniques such as HPLC, NMR, and MS to confirm identity and purity. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing batch-specific results. Our quality standards are designed to support compliance with cGMP, ICH guidelines, and relevant pharmacopoeial requirements for pharmaceutical impurity standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The material should be kept in a dry environment to prevent moisture uptake. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 2.0% w/w

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