Description

Haloperidol Related Compound A (15 Mg) (4,4'-Bis[(4-p-Chlorophenyl)-4-Hydroxy-Piperidino]-Bu-Tyrophenone) is a high-purity reference standard and pharmaceutical impurity critical for analytical research and quality control. This compound is essential for ensuring the safety, efficacy, and regulatory compliance of the antipsychotic drug Haloperidol. It is primarily needed by pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in method development, stability studies, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of related substances in Haloperidol Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, and GC methods to meet ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor impurity levels and ensure product purity meets pharmacopeial standards (USP, EP, BP).
• Stability Studies: Used to track the formation of degradation products under various stress conditions (light, heat, humidity) to determine drug shelf life.
• Regulatory Submissions: Provides necessary impurity data for Drug Master Files (DMFs), New Drug Applications (NDAs), and other regulatory compliance documentation.
• Research & Development: Supports chemical and metabolic pathway studies to understand the degradation and synthesis pathways of Haloperidol.

Basic Information

Product Name	Haloperidol Related Compound A (15 Mg) (4,4'-Bis[(4-p-Chlorophenyl)-4-Hydroxy-Piperidino]-Bu-Tyrophenone)
CAS No.	67987-08-0
Molecular Formula	C44H50Cl2N2O3
Molecular Weight	725.79 g/mol
Synonyms	Haloperidol Impurity A; Haloperidol Related Substance A; 4,4'-Bis(4-(4-chlorophenyl)-4-hydroxypiperidino)butyrophenone; 1-[4-[4-(4-Chlorophenyl)-4-hydroxy-1-piperidinyl]-1-oxobutyl]-4-(4-chlorophenyl)-4-hydroxy-piperidine; Butyrophenone, 4,4'-bis[4-(4-chlorophenyl)-4-hydroxy-1-piperidinyl]-; Haloperidol dimer impurity; Haloperidol degradation product
EINECS	Contact for details

Quality Control

Our Haloperidol Related Compound A is manufactured under strict quality systems to ensure the highest standards of purity and consistency. Each batch is subjected to rigorous analytical testing, including HPLC, NMR, and Mass Spectrometry, to confirm identity and purity. We provide comprehensive Certificates of Analysis (COA) with detailed chromatographic data, ensuring full traceability and compliance with ICH guidelines for impurity standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). The product is light-sensitive and should be handled under appropriate conditions to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single 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.