Description

Haloperidol Impurity A is a specified impurity and degradation product of the antipsychotic drug Haloperidol, identified by CAS NO 4021-57-2. This reference standard is critical for pharmaceutical research, development, and quality control, enabling the accurate identification, quantification, and monitoring of this impurity in active pharmaceutical ingredients (APIs) and finished drug products. It is an essential material for analytical laboratories, regulatory compliance, and manufacturers committed to producing high-purity Haloperidol.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the qualitative and quantitative analysis of Haloperidol Impurity A in drug substances and products.
• Method Development and Validation: Used to develop, optimize, and validate analytical methods, particularly HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance (QC/QA): Essential for routine batch testing to ensure Haloperidol API and formulations meet stringent pharmacopeial purity specifications (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Employed to monitor the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) to determine drug shelf-life.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to comply with FDA, EMA, and other global health authorities.
• Research and Development: Used in synthetic chemistry R&D to understand degradation pathways and improve the synthesis process of Haloperidol to minimize impurity formation.

Basic Information

Product Name	Haloperidol Impurity A
CAS No.	4021-57-2
Molecular Formula	C21H23ClFNO2
Molecular Weight	375.87 g/mol
Synonyms	4-(4-Chlorophenyl)-1-[4-(4-fluorophenyl)-4-oxobutyl]-4-piperidinol; 4-Fluorobutyrophenone Impurity A; 1-(4-Fluorobenzoyl)propyl-4-(4-chlorophenyl)-4-hydroxypiperidine; Haloperidol Related Compound A; Haloperidol EP Impurity A; USP Haloperidol Related Compound A; 4'-Fluoro-4-(4-chlorophenyl)-4-hydroxy-1-butyrophenone piperidine
EINECS	Contact for details

Quality Control

Every batch of Haloperidol Impurity A is manufactured and controlled under a strict quality management system. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, GC, NMR, and MS to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality commitment aligns with cGMP principles and supports compliance with ICH, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. Keep the container sealed to protect the material from moisture absorption.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w

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