Description

Brexpiprazole Impurity 19 is a designated process-related impurity used in the pharmaceutical development and quality control of the antipsychotic drug Brexpiprazole. This high-purity reference standard is critical for ensuring drug safety, efficacy, and regulatory compliance by enabling accurate identification and quantification of this specific impurity. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, method validation, and batch release testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified external standard for the qualitative and quantitative analysis of Brexpiprazole drug substance and finished products.
• Method Development and Validation: Essential for developing, optimizing, and validating analytical methods (e.g., HPLC, UPLC, LC-MS) to monitor impurity profiles.
• Quality Control (QC) Testing: Used in routine QC laboratories to confirm the impurity levels in active pharmaceutical ingredients (APIs) are within specified limits (ICH guidelines).
• Stability Studies: Employed to track the formation and growth of this impurity over time under various stress conditions to establish product shelf life.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Process Chemistry Research: Aids chemists in understanding and optimizing the synthesis pathway of Brexpiprazole to minimize the formation of this impurity.

Basic Information

Product Name	Brexpiprazole Impurity 19
CAS No.	616227-75-9
Molecular Formula	C25H27N3O2S
Molecular Weight	433.57 g/mol
Synonyms	7-{4-[4-(1-Benzothiophen-4-yl)piperazin-1-yl]butoxy}-1,2,3,4-tetrahydroquinolin-2-one; Brexpiprazole Related Compound 19; Brexpiprazole EP Impurity I; Brexpiprazole USP Impurity; UNII-7Q8K1F5W2T; Aripiprazole Derivative; OPC-34712 Impurity 19
EINECS	Contact for details

Quality Control

Our Brexpiprazole Impurity 19 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical characterization using advanced techniques including HPLC, LC-MS, NMR, and IR to confirm identity and ensure high purity. We provide a detailed Certificate of Analysis (COA) with each shipment, which includes batch-specific data on purity, impurities, and residual solvents, supporting compliance with ICH Q3A, Q3B, and relevant pharmacopeial standards (USP, EP).

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 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
Purity (HPLC)	≥ 95.0%
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.