Description

Haloperidol Ep Impurity F is a high-purity reference standard specifically used for the analytical profiling and quality control of the antipsychotic drug Haloperidol. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product safety and regulatory compliance by accurately identifying and quantifying this specified impurity. It is an essential material for research and development, method validation, and stability testing within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Haloperidol Ep Impurity F in Haloperidol Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to monitor impurities according to ICH guidelines.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to ensure Haloperidol products meet stringent pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Employed to track the formation of this impurity under various stress conditions (heat, light, humidity) to establish shelf-life and storage recommendations.
• Regulatory Submissions: Provides essential data for drug master files (DMF), investigational new drug (IND) applications, and new drug applications (NDA) to demonstrate control of impurities.
• Research & Development: Supports impurity profiling, degradation pathway studies, and process chemistry optimization during API synthesis.

Basic Information

Item	Details
Product Name	Haloperidol Ep Impurity F
CAS No.	1391052-67-7
Molecular Formula	C21H23ClFNO2
Molecular Weight	375.87 g/mol
Synonyms	4-(4-Chlorophenyl)-1-[4-(4-fluorophenyl)-4-oxobutyl]-4-piperidinol; Haloperidol Impurity F (EP); Haloperidol Related Compound F; 1-(4-Fluorobenzoyl)propyl-4-(4-chlorophenyl)-4-hydroxypiperidine; Haloperidol Degradation Product; Haloperidol Process Impurity; Haloperidol EP Impurity F
EINECS	Contact for details

Quality Control

Every batch of Haloperidol Ep Impurity F is manufactured and analyzed under strict quality management systems. We provide comprehensive analytical data, including HPLC purity, identity confirmation (IR, NMR, MS), and impurity profile, to ensure compliance with pharmacopeial standards. A detailed Certificate of Analysis (COA) is supplied with each product, confirming its suitability for use as a reference standard in regulated environments.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
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%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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