Description

Solifenacin Impurity 17 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of Solifenacin Succinate. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification during analysis. It is primarily required by analytical laboratories, research institutions, and pharmaceutical manufacturers engaged in method validation, stability studies, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material for the identification and quantification of related substances in Solifenacin Succinate Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating sensitive and specific analytical methods, such as HPLC and LC-MS, to monitor impurity levels.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard in routine QC testing to ensure batch-to-batch consistency and compliance with ICH guidelines.
• Stability Studies: Employed to track the formation and growth of this specific impurity over time under various stress conditions (e.g., heat, humidity, light).
• Regulatory Submissions: Provides necessary data on impurity identity and characterization for regulatory filings with agencies like the FDA, EMA, and PMDA.
• Research & Development: Used in synthetic chemistry research to understand degradation pathways and to synthesize purer batches of the API.

Basic Information

Product Name	Solifenacin Impurity 17
CAS No.	1029430-94-1
Molecular Formula	C23H26N2O2
Molecular Weight	362.47 g/mol
Synonyms	(1S,3'R)-1-Azabicyclo[2.2.2]oct-8-yl 3-(1-phenyl-1,2,3,4-tetrahydroisoquinolin-2-yl)propanoate; Solifenacin Related Compound 17; Solifenacin EP Impurity G; Solifenacin Process Impurity; UNII-9F3Y8Q4B4F; 3-(1-Phenyl-3,4-dihydro-1H-isoquinolin-2-yl)-1-(1-azabicyclo[2.2.2]oct-3-yl)propan-1-one (enantiomer)
EINECS	Contact for details

Quality Control

Our Solifenacin Impurity 17 is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the stringent requirements for pharmaceutical reference standards. A detailed Certificate of Analysis (COA) is provided, which includes batch-specific data on purity, impurities, and chromatographic profiles, supporting compliance with ICH Q3A/B and pharmacopeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under dry conditions to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.