Description

Solifenacin Impurity 1 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 quality control testing. The availability of a well-characterized impurity standard is essential for maintaining stringent pharmacopeial standards in drug production.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Solifenacin Succinate API and finished dosage forms.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or GC methods to monitor process-related impurities.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard in routine batch release testing to ensure product purity meets pharmacopeial specifications (e.g., USP, EP, ICH).
• Stability Studies: Employed to track the formation and level of this specific impurity during forced degradation and long-term stability studies of drug products.
• Regulatory Submissions: Provides necessary data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) filings to health authorities like the FDA and EMA.
• Research & Development: Used in synthetic chemistry research to study impurity formation pathways and to develop improved purification processes.

Basic Information

Product Name	Solifenacin Impurity 1
CAS No.	1353274-25-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
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; Solifenacin Process Impurity; VESIcare Impurity; YM905 Impurity
EINECS	Contact for details

Quality Control

Our Solifenacin Impurity 1 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity confirmation and structural elucidation via NMR and MS, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment, supporting compliance with ICH Q3A(R2) and Q3B(R2) guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material is typically hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

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)	Single unspecified impurity ≤ 0.5% Total impurities ≤ 1.0%
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.