Description

Brexpiprazole Impurity CAS NO 2060027-95-2 is a high-purity chemical reference standard used in the development and quality control of the active pharmaceutical ingredient (API) Brexpiprazole. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification of related substances. It is an essential material for pharmaceutical R&D laboratories, analytical testing facilities, and manufacturers engaged in the production of Brexpiprazole.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for method development and validation in HPLC and LC-MS analysis.
• Impurity Profiling: Identification and quantification of specific process-related or degradation impurities in Brexpiprazole API batches.
• Quality Assurance & Control (QA/QC): Critical for routine testing to ensure API purity meets pharmacopeial standards (e.g., USP, ICH Q3A/B).
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., CMC sections for FDA, EMA) by characterizing impurity structures.
• Stability Studies: Used to monitor the formation of degradation products under various stress conditions.
• Process Chemistry Research: Aids in understanding and optimizing synthetic pathways to minimize impurity formation.

Basic Information

Product Name	Brexpiprazole Impurity
CAS No.	2060027-95-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Brexpiprazole Related Compound; Brexpiprazole Process Impurity; Brexpiprazole Degradant; 7-{4-[4-(1-Benzothiophen-4-yl)piperazin-1-yl]butoxy}-1,2,3,4-tetrahydroquinolin-2-one Impurity; OPC-34712 Impurity; RX-7 Impurity
EINECS	Contact for details

Quality Control

Every batch of Brexpiprazole Impurity is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided to support your regulatory and compliance needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the material should be handled in a low-humidity environment and the container kept tightly sealed after each use to prevent moisture absorption.

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 unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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