Description

Solifenacin Related Compound 13 is a designated impurity or degradation product of the active pharmaceutical ingredient Solifenacin Succinate. This compound is critical for pharmaceutical research and development, serving as a key reference standard in analytical testing. It is primarily used by pharmaceutical manufacturers, contract research organizations (CROs), and quality control laboratories to ensure the purity, safety, and efficacy of Solifenacin-based drug products. The availability of a well-characterized related compound is essential for method validation 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 & Validation: Essential for developing and validating stability-indicating HPLC/UPLC methods in accordance with ICH Q2(R1) guidelines.
• Quality Control & Assurance: Employed in routine batch release testing to monitor impurity profiles and ensure product specifications are met.
• Stability Studies: Used to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) as per ICH Q1A(R2).
• Regulatory Submissions: Provides necessary data on impurity identity and levels for drug master files (DMF), investigational new drug (IND) applications, and new drug applications (NDA).
• Process Chemistry Research: Aids in understanding and optimizing the synthetic pathway of Solifenacin to minimize the formation of this specific impurity.

Basic Information

Product Name	Solifenacin Related Compound 13
CAS No.	1251905-45-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Solifenacin Impurity 13; Solifenacin Related Substance 13; Solifenacin Degradation Product 13; (1S,3'R)-1-Azabicyclo[2.2.2]oct-8-yl 3-(diphenylmethoxy)-1-phenylpropanoate; Vesicare Related Compound 13; Solifenacin EP Impurity C; Solifenacin Process Impurity; Solifenacin Succinate Impurity
EINECS	Contact for details

Quality Control

Every batch of Solifenacin Related Compound 13 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques such as HPLC, GC, NMR, and MS to ensure they meet the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) is supplied with each product, detailing batch-specific results, analytical methods, and traceability. We support compliance with ICH, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The product is hygroscopic (moisture-sensitive) and should be handled 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 structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.