Description

Tolterodine Lactol Impurity is a key chemical reference standard used in the pharmaceutical development and quality control of Tolterodine, an antimuscarinic drug. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the final active pharmaceutical ingredient (API). It is primarily required by analytical laboratories, research institutions, and pharmaceutical manufacturers involved in method validation, stability studies, and impurity profiling to meet stringent pharmacopeial standards like USP and ICH guidelines.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quantitative and qualitative analysis of Tolterodine API and related drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Used to develop, calibrate, and validate chromatographic methods for accurate impurity detection and quantification.
• Quality Control & Assurance (QC/QA): Essential for routine batch testing to monitor and control impurity levels, ensuring product consistency and compliance with regulatory filings.
• Stability Studies: Employed to identify and track degradation products in Tolterodine formulations under various stress conditions.
• Regulatory Submission & Compliance: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to meet FDA, EMA, and ICH Q3A/B requirements.
• Research & Development (R&D): Used in synthetic chemistry research to study metabolic pathways, degradation mechanisms, and to synthesize purer forms of the API.

Basic Information

Product Name	Tolterodine Lactol Impurity
CAS No.	209747-04-6
Molecular Formula	C22H31NO3
Molecular Weight	357.49 g/mol
Synonyms	(R)-2-[3-(Diisopropylamino)-1-phenylpropyl]-4-methylphenol Lactol; Tolterodine EP Impurity C; Tolterodine Lactol; Tolterodine Related Compound C; (R)-α-Phenyl-β-[N,N-diisopropylamino]ethyl-2-methyl-5-hydroxybenzyl Alcohol Lactol Form; 5-[(3R)-3-(Diisopropylamino)-1-phenylpropyl]-2-methylphenyl Dihydrogen Phosphate (lactol form); Tolterodine Process Impurity.
EINECS	Contact for details

Quality Control

Every batch of Tolterodine Lactol Impurity is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Our quality system is designed to meet the exacting standards of pharmaceutical impurity supply, with testing typically including HPLC for assay and related substances, IR and MS for identification, and residual solvent analysis. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing all test results against predefined specifications aligned with ICH guidelines.

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 compound is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Any individual impurity ≤ 1.0% Total impurities ≤ 3.0%
Water Content (KF)	≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C

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