Description

Solifenacin Impurity 1 HCl is a high-purity chemical reference standard specifically identified as a process-related impurity of the active pharmaceutical ingredient Solifenacin Succinate. This compound is critical for pharmaceutical research, development, and quality control, enabling the accurate identification, quantification, and monitoring of this specific impurity during drug manufacturing. It is an essential material for analytical chemists and quality assurance professionals in the pharmaceutical industry who require reliable reference standards to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling and Characterization: Used as a certified reference standard to identify and quantify Solifenacin Impurity 1 in active pharmaceutical ingredient (API) batches and finished drug products.
• Analytical Method Development and Validation: Serves as a critical component in developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity analysis.
• Quality Control and Release Testing: Employed in routine QC laboratories to ensure Solifenacin Succinate API meets stringent pharmacopeial (e.g., USP, EP) or internal purity specifications.
• Stability Studies and Forced Degradation Testing: Acts as a marker to track the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions and Compliance: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity control and understanding of the drug substance.
• Research on Synthesis Pathways: Used in process chemistry research to understand and mitigate the formation of this impurity during the synthesis of Solifenacin.

Basic Information

Product Name	Solifenacin Impurity 1 HCl
CAS No.	1243274-81-8
Molecular Formula	C23H26N2O2 • HCl
Molecular Weight	414.93 g/mol (for free base: 362.47 g/mol)
Synonyms	(1S)-(3R)-1-Azabicyclo[2.2.2]oct-3-yl (1S)-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate hydrochloride; (3R)-1-Azabicyclo[2.2.2]oct-3-yl (1S)-1,2,3,4-tetrahydro-1-phenylisoquinoline-2-carboxylate hydrochloride; Solifenacin Related Compound 1 HCl; Solifenacin EP Impurity B HCl; Solifenacin USP Impurity 1 HCl
EINECS	Contact for details

Quality Control

Every batch of Solifenacin Impurity 1 HCl is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, GC, MS, NMR, and IR spectroscopy to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, analytical methods, and traceability.

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 hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccated conditions.

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%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual unknown impurity ≤ 0.10%; Total impurities ≤ 1.0%

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