Description

Brexpiprazole Impurity 34 is a designated process-related impurity or degradation product of the active pharmaceutical ingredient Brexpiprazole. This high-purity reference standard is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing. It is essential for researchers and quality assurance professionals in the pharmaceutical industry who require reliable materials to ensure drug safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material for the identification and quantification of impurities in Brexpiprazole drug substance and finished dosage forms.
• Analytical Method Development: Serves as a critical component in developing and optimizing HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor and control impurity levels, ensuring product consistency and meeting ICH guidelines.
• Regulatory Compliance & Filing: Provides necessary data for regulatory submissions (e.g., to FDA, EMA) to establish impurity thresholds and justify specifications.
• Stability Studies: Used to track the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) to determine drug product shelf-life.
• Research & Development: Facilitates studies on the degradation pathways and chemical behavior of Brexpiprazole during synthesis and formulation.

Basic Information

Product Name	Brexpiprazole Impurity 34
CAS No.	2247155-42-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	7-{4-[4-(1-Benzothiophen-4-yl)piperazin-1-yl]butoxy}-1,2,3,4-tetrahydroquinolin-2-one; Brexpiprazole Related Compound 34; Brexpiprazole Impurity K; UNII-7K1P8Y2V7I; 1,2,3,4-Tetrahydro-7-[4-[4-(4-thianaphthenyl)-1-piperazinyl]butoxy]-2-quinolinone; Brexpiprazole EP Impurity K
EINECS	Contact for details

Quality Control

Every batch of Brexpiprazole Impurity 34 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and research requirements.

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. Keep the container in a dry, cool, and well-ventilated area.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
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%

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