Description

Brexpiprazole Impurity 44 is a designated impurity standard used in the pharmaceutical development and quality control of Brexpiprazole, an atypical antipsychotic. This high-purity reference material is critical for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API) by enabling accurate identification and quantification of process-related impurities. It is an essential tool for analytical chemists and quality assurance professionals in pharmaceutical R&D, manufacturing, and regulatory affairs.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Brexpiprazole Impurity 44 in API and finished drug products.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating stability-indicating HPLC, UPLC, or LC-MS methods for Brexpiprazole.
• Quality Control & Batch Release Testing: Used in routine QC laboratories to monitor impurity profiles and ensure batches meet stringent ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Employed to track the formation and levels of this specific impurity under various stress conditions (heat, light, humidity) as per ICH Q1A(R2).
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs).
• Process Chemistry Research: Aids in understanding the formation pathway of this impurity during synthesis, helping to optimize manufacturing processes for impurity minimization.

Basic Information

Product Name	Brexpiprazole Impurity 44
CAS No.	220364-99-8
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; Brexpiprazole Related Compound 44; Brexpiprazole EP Impurity I; Brexpiprazole USP Impurity; OPC-34712 Impurity 44; 7-[4-[4-(1-Benzothiophen-4-yl)-1-piperazinyl]butoxy]-2(1H)-quinolinone
EINECS	Contact for details

Quality Control

Every batch of Brexpiprazole Impurity 44 is manufactured and analyzed under strict quality systems. Our products undergo rigorous identity, purity, and impurity profile testing using validated chromatographic (HPLC/UPLC) and spectroscopic methods to ensure compliance with pharmacopeial standards (USP, EP) and ICH guidelines. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, analytical procedures, 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 Certificate of Analysis. Keep the container in a dry, cool, and well-ventilated place. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 95.0%
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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