Description

Solifenacin Ep Impurity B is a high-purity reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Solifenacin Succinate. This compound is critical for pharmaceutical manufacturers and research laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying process-related impurities. It is essential for professionals engaged in method development, stability studies, and the synthesis of high-grade pharmaceuticals within the global life sciences sector.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the quantitative and qualitative analysis of Solifenacin Succinate API.
• Method Development & Validation: Crucial for developing and validating robust HPLC, UPLC, or LC-MS analytical methods in QC laboratories.
• Stability Indicating Studies: Used to monitor the formation of this specific impurity during forced degradation and long-term stability studies of drug products.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity characterization data for drug master files.
• Process Chemistry Research: Aids chemists in optimizing synthesis pathways to minimize the formation of this impurity during API manufacturing.
• Quality Control Testing: Employed in routine batch release testing to ensure impurity levels are within International Council for Harmonisation (ICH) guidelines.

Basic Information

Product Name	Solifenacin Ep Impurity B
CAS No.	1534326-81-2
Molecular Formula	C23H26N2O2
Molecular Weight	362.47 g/mol
Synonyms	(1S,3'R)-1-Azabicyclo[2.2.2]octan-3'-yl (1S)-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate; Solifenacin Related Compound B; Solifenacin Impurity B; (3R)-1-Azabicyclo[2.2.2]oct-3-yl (1S)-2-oxo-1-phenyl-1,2,3,4-tetrahydroisoquinoline-3-carboxylate; VESIcare Impurity B
EINECS	Contact for details

Quality Control

Every batch of Solifenacin Ep Impurity B is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing to ensure identity, purity, and consistency, aligning with current pharmacopeial standards and ICH Q3A/B guidelines for impurities. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from advanced chromatographic and spectroscopic methods.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container should be kept in a desiccated environment to maintain stability and purity. 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%

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