Description

Tolterodine Ep Impurity C Hcl is a high-purity reference standard used in the analytical profiling and quality control of Tolterodine, an active pharmaceutical ingredient (API). This compound is critical for ensuring the safety and efficacy of Tolterodine-based medications by serving as a benchmark for impurity identification and quantification. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and batch release testing.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of Tolterodine Ep Impurity C in Tolterodine API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to monitor process-related impurities.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and a calibrant in routine QC testing to ensure batch-to-batch consistency and compliance with pharmacopeial limits (e.g., ICH Q3A/B).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing definitive impurity characterization data required by agencies like the FDA and EMA.
• Stability Studies: Employed to track the formation of this specific impurity under various stress conditions (heat, light, humidity) as part of drug stability testing programs.
• Research & Development: Used in R&D laboratories to study the degradation pathways and chemical behavior of Tolterodine during synthesis and formulation.

Basic Information

Product Name	Tolterodine Ep Impurity C Hcl
CAS No.	1161940-88-0
Molecular Formula	C22H31NO•HCl
Molecular Weight	361.95 g/mol
Synonyms	(R)-2-[3-(Diisopropylamino)-1-phenylpropyl]-4-methylphenol Hydrochloride; Tolterodine EP Impurity C Hydrochloride; Tolterodine Related Compound C HCl; (R)-N,N-Diisopropyl-3-(2-hydroxy-5-methylphenyl)-3-phenylpropanamine Hydrochloride; Tolterodine Impurity C (HCl Salt); Tolterodine Process Impurity C Hydrochloride; Detrol Impurity C HCl
EINECS	Contact for details

Quality Control

Every batch of Tolterodine Ep Impurity C Hcl is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced chromatographic (HPLC, UPLC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry, cool place. The material is hygroscopic (moisture-sensitive) and must be kept under inert conditions upon opening to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Purity (HPLC)	≥ 99.0%
Single Unknown Impurity	≤ 0.5%
Total Impurities	≤ 1.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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