Description

Tolterodine Impurity 5 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of Tolterodine, an active pharmaceutical ingredient used in the treatment of overactive bladder. It is primarily required by pharmaceutical manufacturers, quality control laboratories, and research institutions involved in method development and validation. The availability of this well-characterized impurity is essential for compliance with stringent regulatory guidelines for drug substance and product purity.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Tolterodine Impurity 5 in Tolterodine Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development: Essential for developing and validating chromatographic methods, such as HPLC and UPLC, to monitor impurities in Tolterodine manufacturing processes.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine testing to ensure Tolterodine batches meet pharmacopeial (e.g., USP, EP) and ICH Q3A/B impurity limits.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as part of drug stability profiling.
• Regulatory Submissions: Provides necessary data and characterization for inclusion in regulatory filings (e.g., CMC sections of FDA, EMA dossiers) to demonstrate comprehensive impurity control.
• Research & Development: Used in academic and industrial R&D to study the metabolic pathways, degradation mechanisms, and toxicological profile of Tolterodine-related compounds.

Basic Information

Product Name	Tolterodine Impurity 5
CAS No.	173948-30-6
Molecular Formula	C22H31NO
Molecular Weight	325.49 g/mol
Synonyms	(R)-N,N-Diisopropyl-3-(2-hydroxy-5-methylphenyl)-3-phenylpropanamine; (R)-2-[3-(Diisopropylamino)-1-phenylpropyl]-4-methylphenol; Tolterodine Related Compound E; Tolterodine EP Impurity E; Tolterodine USP Impurity E; Tolterodine Process Impurity; (R)-Tolterodine Alcohol Impurity
EINECS	Contact for details

Quality Control

Our Tolterodine Impurity 5 is manufactured under strict quality systems to ensure it meets the exacting standards required for pharmaceutical analysis. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) that includes data from multiple orthogonal analytical techniques. We ensure compliance with relevant pharmacopeial guidelines (USP, EP, ICH) for impurity reference standards. Certificates of Analysis (COA) are available upon request and provide full traceability of analytical results.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

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%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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