Description

Haloperidol Ep Impurity E is a specified impurity used in the quality control and analytical profiling of the antipsychotic drug Haloperidol. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure drug purity, safety, and compliance with stringent pharmacopeial standards such as the European Pharmacopoeia (EP). It is primarily utilized by professionals in pharmaceutical R&D, quality assurance, and regulatory affairs for method development, validation, and batch release testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Haloperidol-related impurities in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Batch Release: Used in routine QC testing to ensure Haloperidol batches meet the specified impurity limits as per EP, USP, or ICH guidelines.
• Stability Studies: Employed to identify and track degradation products formed under various stress conditions (e.g., heat, light, humidity) during drug stability testing.
• Regulatory Submissions: Provides necessary impurity data for regulatory filings (e.g., CMC sections for FDA, EMA) to demonstrate thorough impurity characterization.
• Research & Development: Supports synthetic route optimization and process chemistry by helping to identify and control process-related impurities.

Basic Information

Item	Details
Product Name	Haloperidol Ep Impurity E
CAS No.	1391054-69-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Haloperidol Impurity E; Haloperidol EP Impurity E; Haloperidol Related Compound E; 4-(4-Chlorophenyl)-4-hydroxypiperidine Impurity; Haloperidol Degradation Product; Haloperidol Process Impurity; Haloperidol Specified Impurity E
EINECS	Contact for details

Quality Control

Our Haloperidol Ep Impurity E is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and structural characterization via spectroscopic methods (IR, MS, NMR), to ensure it meets the high standards required for use as a reference material. Certificates of Analysis (COA) with detailed chromatographic data are provided and traceable to primary standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH limits

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