Description

Solifenacin Impurity 18 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Solifenacin Succinate. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Solifenacin Succinate API and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity levels.
• Quality Control & Assurance (QC/QA): Essential for in-house quality control testing to ensure API batches meet stringent pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing necessary data on impurity identity and control strategies.
• Stability Studies: Employed in forced degradation and long-term stability studies to track the formation and behavior of this impurity over time.
• Research & Development (R&D): Used in pharmaceutical R&D to study the synthesis pathway, degradation mechanisms, and chemical behavior of Solifenacin-related compounds.

Basic Information

Product Name	Solifenacin Impurity 18
CAS No.	1243274-83-0
Molecular Formula	C23H26N2O2
Molecular Weight	362.47 g/mol
Synonyms	(1S,3'R)-1-Azabicyclo[2.2.2]oct-3-yl (1R)-1-Phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate; Solifenacin Related Compound 18; Solifenacin EP Impurity 18; Solifenacin USP Impurity 18; (3R)-1-Azabicyclo[2.2.2]oct-3-yl (1R)-3,4-Dihydro-1-phenylisoquinoline-2(1H)-carboxylate; UNII-4Q8I7T6J7R
EINECS	Contact for details

Quality Control

Our Solifenacin Impurity 18 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the highest standards for pharmaceutical reference materials. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles. We adhere to relevant ICH guidelines and can support compliance with USP, EP, and other pharmacopeial standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to ensure stability.

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.