Description

Tolterodine Ep Impurity G is a designated impurity standard used in the analytical profiling and quality control of Tolterodine, an active pharmaceutical ingredient (API) for treating overactive bladder. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and compliance with stringent pharmacopeial standards such as the European Pharmacopoeia (EP). It is primarily utilized by R&D scientists, QC/QA professionals, and regulatory affairs specialists in the pharmaceutical industry for method development, validation, and batch release testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Tolterodine Ep Impurity G in Tolterodine API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC/UPLC methods as per ICH guidelines.
• Quality Control & Batch Release: Used in routine QC testing to monitor impurity levels and ensure batches meet EP, USP, or in-house specifications.
• Stability Studies: Employed to track the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) during drug product shelf-life studies.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., CMC sections for FDA, EMA) to demonstrate control of the API manufacturing process.
• Pharmacopeial Compliance: Directly supports compliance testing requirements outlined in the European Pharmacopoeia monographs for Tolterodine.

Basic Information

Product Name	Tolterodine Ep Impurity G
CAS No.	1554029-91-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(2R,3R)-2-[3-(Diisopropylamino)-1-phenylpropyl]-4-(hydroxymethyl)-2,3-dihydro-1H-isoindol-1-one; Tolterodine Impurity G; Tolterodine EP Impurity G; Tolterodine Related Compound G; 1H-Isoindol-1-one, 2,3-dihydro-4-(hydroxymethyl)-2-[3-[bis(1-methylethyl)amino]-1-phenylpropyl]-, (2R,3R)-; Tolterodine Isomer Impurity
EINECS	Contact for details

Quality Control

Every batch of Tolterodine Ep Impurity G is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC and MS to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container should be kept in a desiccated environment to prevent moisture uptake. 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 to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
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.