Description

Solifenacin Related Compound 29 is a high-purity chemical reference standard, identified by CAS No. 861998-77-8. This compound is essential 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 quality control departments for use in method development, validation, and impurity profiling. This standard supports critical processes in drug development and production by providing a benchmark for identification and quantification.

Application

• Pharmaceutical Impurity Reference Standard: Used as a specified impurity for the identification and quantification of related substances in Solifenacin Succinate API and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, UPLC, or GC methods for stability-indicating assays.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor impurity levels and ensure product meets pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Used to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDA).
• Research & Development: Facilitates process chemistry research, impurity isolation, and structural elucidation studies.

Basic Information

Product Name	Solifenacin Related Compound 29
CAS No.	861998-77-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Solifenacin Impurity 29; Solifenacin Related Substance 29; Solifenacin Succinate Impurity 29; 1-Azabicyclo[2.2.2]oct-8-yl (1S)-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate (enantiomer related to Solifenacin); Vesicare Impurity 29; (S)-1-Phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylic acid (1-azabicyclo[2.2.2]oct-8-yl) ester; YM-905 Related Compound 29
EINECS	Contact for details

Quality Control

Every batch of Solifenacin Related Compound 29 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, GC, NMR, and MS to ensure compliance with industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH, USP, and EP guidelines for impurities in new drug substances.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). Keep the container in a dry, cool, and well-ventilated area. For long-term storage under inert atmosphere, please contact us for specific recommendations.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%
Assay	98.0% - 102.0% (on anhydrous basis)

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