Description

Brexpiprazole Impurity 5 Hcl is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for the quality control and regulatory compliance of the active pharmaceutical ingredient (API) Brexpiprazole, ensuring the safety and efficacy of the final drug product. It is primarily required by analytical laboratories, pharmaceutical manufacturers, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of specific impurities in Brexpiprazole API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods in compliance with ICH guidelines.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine batch release testing in pharmaceutical manufacturing to monitor impurity levels.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDA) to meet FDA, EMA, and other global health authority requirements.
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress conditions (thermal, photolytic, hydrolytic) as part of forced degradation studies.
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the degradation pathways of Brexpiprazole.

Basic Information

Product Name	Brexpiprazole Impurity 5 Hcl
CAS No.	105684-85-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	7-{4-[4-(1-Benzothiophen-4-yl)piperazin-1-yl]butoxy}-1H-quinolin-2-one Hydrochloride; Brexpiprazole Related Compound 5 HCl; Brexpiprazole Impurity C HCl; 7-[4-[4-(1-Benzothiophen-4-yl)-1-piperazinyl]butoxy]-2(1H)-quinolinone Hydrochloride; UNII-8KQ660O15B; OPC-34712 Impurity 5 Hydrochloride
EINECS	Contact for details

Quality Control

Every batch of Brexpiprazole Impurity 5 Hcl is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (HPLC, LC-MS, NMR) to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available upon request.

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 (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Assay (HPLC)	≥ 95.0%
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	< 20 ppm

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