Description

Solifenacin Related Compound 25 is a designated impurity or degradation product associated with the active pharmaceutical ingredient Solifenacin Succinate. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development and validation. It is primarily used by pharmaceutical manufacturers, quality control laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Solifenacin-based drug products. The availability of a well-characterized related compound is essential for meeting stringent pharmacopeial requirements and regulatory compliance.

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 impurity profiles during stability studies and manufacturing.
• Quality Control & Assurance: Employed in routine QC testing to ensure batch-to-batch consistency and compliance with ICH Q3A(R2) and Q3B(R2) guidelines on impurities.
• Regulatory Submissions: Provides necessary data for Drug Master Files (DMFs), Common Technical Documents (CTD), and other regulatory filings to health authorities like the FDA and EMA.
• Stability Studies: Acts as a marker to track degradation pathways and establish the shelf-life of pharmaceutical products containing Solifenacin.
• Process Chemistry Research: Used to study and optimize synthetic pathways to minimize the formation of this specific impurity.

Basic Information

Product Name	Solifenacin Related Compound 25
CAS No.	134021-15-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Solifenacin Impurity 25; Solifenacin EP Impurity J; Solifenacin Related Substance 25; (1S)-(3R)-1-Azabicyclo[2.2.2]oct-3-yl (2S)-2,2-diphenyl-2-(hydroxy)acetate; Solifenacin Hydroxy Acid; UNII-6Q1G4QK5Q2; Solifenacin Carboxylic Acid Derivative
EINECS	Contact for details

Quality Control

Our Solifenacin Related Compound 25 is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR, MS), purity assessment by HPLC, and control of residual solvents and moisture. We provide a detailed Certificate of Analysis (COA) with each shipment, which includes batch-specific data, chromatograms, and traceability information. Our quality commitment aligns with the standards expected for pharmaceutical reference materials, supporting compliance with ICH, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15°C and 25°C (59°F and 77°F). The product is light-sensitive and should be handled under appropriate conditions to prevent degradation. Keep the container in a dry environment to minimize moisture uptake.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Water Content (KF)	≤ 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.