Description

Tolterodine Ep Impurity D CAS NO 1391053-65-8 is a high-purity chemical reference standard specifically used in the analytical profiling of Tolterodine, an active pharmaceutical ingredient. This compound is critical for pharmaceutical quality control and regulatory compliance, serving as a key marker for process-related impurities. It is essential for analytical chemists and quality assurance professionals in pharmaceutical development and manufacturing. The material supports method validation, stability studies, and ensures adherence to stringent pharmacopeial guidelines.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the identification and quantification of Tolterodine-related substances.
• Analytical Method Development & Validation (HPLC/LC-MS): Used to develop, optimize, and validate chromatographic methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Critical for routine batch testing of Tolterodine Active Pharmaceutical Ingredient (API) to monitor and control impurity levels.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs).
• Stability Studies: Employed to track the formation of degradation products in Tolterodine formulations under various storage conditions.
• Research & Development (R&D): Used in synthetic route optimization and process chemistry to understand and minimize impurity formation during API synthesis.

Basic Information

Product Name	Tolterodine Ep Impurity D
CAS No.	1391053-65-8
Molecular Formula	C22H31NO
Molecular Weight	325.49 g/mol
Synonyms	(R)-2-[3-(Diisopropylamino)-1-phenylpropyl]-4-methylphenol; Tolterodine Impurity D; Tolterodine Related Compound D; Tolterodine EP Impurity D; (R)-N,N-Diisopropyl-3-(2-hydroxy-5-methylphenyl)-3-phenylpropan-1-amine; Tolterodine Isomer; (3R)-3-(2-Hydroxy-5-methylphenyl)-N,N-diisopropyl-3-phenylpropan-1-amine
EINECS	Contact for details

Quality Control

Every batch of Tolterodine Ep Impurity D is manufactured and analyzed under strict quality management systems. The material is characterized using advanced spectroscopic and chromatographic techniques (NMR, HPLC, LC-MS) to ensure structural identity and high purity, meeting the requirements for use as a reference standard. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, assay, and impurity profile. Our quality commitment aligns with cGMP principles to support your regulatory needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). Keep the container in a dry, cool, and well-ventilated area. For long-term storage under inert atmosphere, please contact us for specific recommendations.

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%
Assay	97.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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