Description

Solifenacin Related Compound 14 is a high-purity chemical reference standard, identified by CAS number 605696-10-4, which is critical for pharmaceutical research and quality control processes. This compound serves as a key impurity marker and analytical standard for ensuring the purity and safety profile 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 compliance testing. The availability of this well-characterized related compound is essential for maintaining stringent quality standards in drug development and production.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify, quantify, and monitor specific impurities in Solifenacin Succinate API batches.
• Analytical Method Development and Validation: Essential for developing and validating stability-indicating HPLC or UPLC methods in accordance with ICH Q2(R1) guidelines.
• Quality Control and Release Testing: Employed in routine QC laboratories to establish acceptance criteria and ensure API purity meets pharmacopeial standards (e.g., USP, EP).
• Stability Studies: Used to track the formation of degradation products under various stress conditions (heat, light, humidity) as part of ICH stability protocols.
• Regulatory Submissions: Provides necessary data on impurity structure and behavior for regulatory filings (e.g., FDA, EMA) to support drug approval.
• Research and Development: Supports synthetic route optimization and process chemistry by helping to understand and control impurity formation.

Basic Information

Product Name	Solifenacin Related Compound 14
CAS No.	605696-10-4
Molecular Formula	C23H26N2O2
Molecular Weight	362.47 g/mol
Synonyms	Solifenacin Impurity 14; (1S,3'R)-1-Azabicyclo[2.2.2]oct-3-yl (1-phenyl-1,2,3,4-tetrahydroisoquinolin-3'-yl)carbamate; Solifenacin EP Impurity H; Solifenacin USP Related Compound 14; UNII-9J8K3A9U4Q; 1-Phenyl-1,2,3,4-tetrahydro-3-isoquinolinyl (3R)-1-azabicyclo[2.2.2]oct-3-ylcarbamate; Solifenacin Carbamate Impurity
EINECS	Contact for details

Quality Control

Our Solifenacin Related Compound 14 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the exacting standards required for pharmaceutical reference materials. Certificates of Analysis (COA) are provided with each shipment, detailing batch-specific results. We support compliance with ICH, USP, and EP guidelines, and our quality systems are designed to meet the needs of cGMP environments.

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 product is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment 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 corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Water Content (KF)	≤ 0.5%
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.