Description

Dechloro Haloperidol (Haloperidol Impurity B) is a key chemical reference standard and impurity used in the pharmaceutical development and quality control of Haloperidol, a widely used antipsychotic medication. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a benchmark in analytical testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, method validation, and compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified standard for the identification and quantification of Haloperidol Impurity B in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating chromatographic methods (HPLC, GC) and spectroscopic analyses in quality control laboratories.
• Impurity Profiling & Control: Critical for establishing impurity profiles, setting specification limits, and ensuring batch-to-batch consistency of Haloperidol API in compliance with ICH Q3A/B guidelines.
• Regulatory Compliance & Submission: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary data on impurity identification and control strategies.
• Stability Studies: Employed in forced degradation and long-term stability studies to monitor the formation and levels of this specific degradation impurity.
• Research & Development: Used in synthetic chemistry research to study the metabolism, degradation pathways, and structure-activity relationships of Haloperidol and related compounds.

Basic Information

Product Name	Dechloro Haloperidol (Haloperidol Impurity B)
CAS No.	3109-12-4
Molecular Formula	C21H23FNO2
Molecular Weight	340.42 g/mol
Synonyms	4-Fluoro-4-[4-(4-fluorophenyl)-4-oxobutyl]-1-piperidinyl]-1-(4-fluorophenyl)-1-butanone; 1-Butanone, 4-[4-(4-fluorophenyl)-4-oxobutyl]-1-piperidinyl]-1-(4-fluorophenyl)-4-fluoro-; Haloperidol Impurity B; Haloperidol Related Compound B; Dechlorohaloperidol; Deschlorohaloperidol; 4'-Fluoro-4-(4-(4-fluorobenzoyl)piperidino)butyrophenone
EINECS	Contact for details

Quality Control

Our Dechloro Haloperidol is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, identity confirmation by IR and MS, and residual solvent analysis, to ensure it meets the stringent requirements for use as a pharmaceutical reference standard. Certificates of Analysis (COA) with detailed chromatograms and traceable data are provided with every shipment.

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 should be kept in a desiccated environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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