Description

Solifenacin Impurity 2 is a specified impurity of the active pharmaceutical ingredient (API) Solifenacin Succinate, a medication used to treat overactive bladder. This compound is critical for pharmaceutical research and development, serving as a certified reference standard for analytical method development and validation. It is essential for quality control laboratories and API manufacturers to ensure the purity, safety, and regulatory compliance of the final drug product. This high-purity material is primarily used by analytical chemists and quality assurance professionals in the pharmaceutical industry.

Application

• Primary use as a certified reference standard for the identification and quantification of impurities in Solifenacin Succinate API.
• Critical component in analytical method development and validation (HPLC, UPLC, GC) for quality control protocols.
• Used in stability studies to monitor impurity profiles of pharmaceutical formulations over time.
• Essential for regulatory compliance and submission (e.g., for ICH guidelines Q3A(R2) and Q3B(R2)).
• Serves as a key material in pharmaceutical research to understand degradation pathways.
• Supports pharmacopoeial testing to meet standards set by USP, EP, or other compendia.

Basic Information

Item	Detail
Product Name	Solifenacin Impurity 2
CAS No.	1229227-22-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(1S)-(3R)-1-Azabicyclo[2.2.2]oct-3-yl (1R)-1-Phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate; Solifenacin Related Compound; Solifenacin EP Impurity; Solifenacin USP Impurity; Solifenacin Process Impurity; Vesicare Impurity; YM905 Impurity
EINECS	Contact for details

Quality Control

Our Solifenacin Impurity 2 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and identity verification by spectroscopic methods (IR, NMR, MS). We provide comprehensive Certificates of Analysis (COA) with batch-specific data, ensuring traceability and compliance with ICH guidelines. The material is suitable for use as a pharmaceutical reference standard in regulated environments.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
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.