Description

Droperidol Impurity E CAS NO 1346604-17-8 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, specifically in the development and validation of analytical methods for the antipsychotic drug Droperidol. It is an essential tool for researchers and quality assurance professionals in the pharmaceutical and contract research organization (CRO) sectors who require reliable impurities for method development, stability studies, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of impurities in Droperidol Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): A critical component for developing, optimizing, and validating chromatographic methods to ensure specificity, accuracy, and precision.
• Stability Studies & Forced Degradation: Used to monitor the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., FDA, EMA) by providing necessary impurity profiles and data for New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs).
• Quality Control (QC) Testing: Serves as a system suitability standard and for routine batch release testing in pharmaceutical manufacturing to ensure impurity levels are within ICH guidelines.
• Academic & Clinical Research: Used in studies investigating the metabolism, pharmacokinetics, and safety profile of Droperidol and related compounds.

Basic Information

Product Name	Droperidol Impurity E
CAS No.	1346604-17-8
Molecular Formula	C22H22FN3O2
Molecular Weight	379.43 g/mol
Synonyms	1-[1-[4-(4-Fluorophenyl)-4-oxobutyl]-1,2,3,6-tetrahydro-4-pyridinyl]-1,3-dihydro-2H-benzimidazol-2-one; Droperidol Related Compound E; Droperidol EP Impurity E; Droperidol USP Impurity E; 4'-Fluoro-4-[4-(2-oxo-2,3-dihydro-1H-benzimidazol-1-yl)-1,2,3,6-tetrahydropyridin-1-yl]butyrophenone
EINECS	Contact for details

Quality Control

Every batch of Droperidol Impurity E (CAS 1346604-17-8) is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assessment, and impurity profiling using advanced analytical techniques such as HPLC, GC, MS, and NMR to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing at 2-8°C. The container should be kept in a well-ventilated area.

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)	Any individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5%
Assay	97.0% - 103.0% (on anhydrous basis)

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