Description

Tolterodine Impurity 4 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) Tolterodine L-tartrate, a medication used to treat overactive bladder. It serves as an essential tool for pharmaceutical manufacturers and analytical laboratories engaged in method development, validation, and routine quality control testing. The availability of this well-characterized impurity standard is fundamental for regulatory compliance and maintaining the highest standards in pharmaceutical production.

Application

• Pharmaceutical Quality Control (QC): Used as a certified reference material for the identification and quantification of this specific impurity in Tolterodine API and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Regulatory Compliance & Documentation: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing a characterized impurity for specification setting.
• Stability Studies: Employed as a marker to track the formation and level of this impurity during forced degradation and long-term stability studies of Tolterodine.
• Research & Development (R&D): Used in pharmaceutical R&D to study the degradation pathways, synthesis impurities, and metabolic profiles of Tolterodine.
• Calibration Standard: Serves as a primary or secondary standard for calibrating analytical instruments to ensure accurate impurity measurement.

Basic Information

Product Name	Tolterodine Impurity 4
CAS No.	906532-18-1
Molecular Formula	C22H31NO
Molecular Weight	325.49 g/mol
Synonyms	(R)-N,N-Diisopropyl-3-(2-hydroxy-5-methylphenyl)-3-phenylpropan-1-amine; (R)-N,N-Diisopropyl-3-(2-hydroxy-5-methylphenyl)-3-phenylpropylamine; Tolterodine Related Compound C; Tolterodine EP Impurity C; Tolterodine USP Impurity C; Tolterodine Process Impurity; 2-[(1R)-3-(Diisopropylamino)-1-phenylpropyl]-4-methylphenol
EINECS	Contact for details

Quality Control

Every batch of Tolterodine Impurity 4 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing to ensure identity, purity, and consistency, meeting the stringent requirements for pharmaceutical reference standards. Comprehensive characterization is performed using advanced techniques including HPLC, GC, NMR, and MS. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with specifications and traceability to primary standards.

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 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 (HPLC)	Conforms
Identification (IR)	Conforms
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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