Description

Tolterodine Impurity 5 is a specified impurity and reference standard used in the quality control and analytical profiling of the active pharmaceutical ingredient (API) Tolterodine. This compound is critical for ensuring the purity, safety, and efficacy of Tolterodine-based pharmaceutical formulations through rigorous analytical methods. It is primarily required by pharmaceutical manufacturers, quality control laboratories, and regulatory bodies for method development, validation, and batch release testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Tolterodine Impurity 5 in Tolterodine API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Batch Release: Serves as a system suitability standard in routine QC testing to ensure compliance with pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Employed to track the formation and level of this specific degradation product under various stress conditions (thermal, photolytic, hydrolytic).
• Regulatory Submissions: Provides necessary impurity characterization data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Used in synthetic chemistry R&D to understand and control impurity formation pathways during the manufacturing process of Tolterodine.

Basic Information

Product Name	Tolterodine Impurity 5
CAS No.	124936-70-5
Molecular Formula	C22H31NO
Molecular Weight	325.49 g/mol
Synonyms	(R)-N,N-Diisopropyl-3-(2-hydroxy-5-methylphenyl)-3-phenylpropanamine; (R)-Tolterodine Impurity 5; (R)-Tolterodine Related Compound A; Tolterodine EP Impurity B; Tolterodine USP Related Compound A; (3R)-N,N-Diisopropyl-3-(2-hydroxy-5-methylphenyl)-3-phenylpropan-1-amine; (R)-Desisopropyl Tolterodine
EINECS	Contact for details

Quality Control

Our Tolterodine Impurity 5 is manufactured and handled in a GMP-compliant environment. Each batch undergoes rigorous analytical characterization using techniques such as HPLC, GC, NMR, and MS to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results against established specifications. Our quality system ensures traceability and compliance with relevant pharmacopeial guidelines (USP, EP) and ICH regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. The material is hygroscopic (moisture-sensitive) and should be kept in a dry environment. 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)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w

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