Description

Droperidol Impurity B is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the antipsychotic drug Droperidol. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The product is supplied with comprehensive analytical data to support stringent quality control protocols.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the quality control and release testing of Droperidol Active Pharmaceutical Ingredients (APIs) and finished dosage forms.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or GC methods to accurately identify and quantify Droperidol Impurity B in drug substances and products.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., with FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Employed in forced degradation and long-term stability studies to monitor the formation of this specific impurity under various stress conditions.
• Research & Development: Serves as a key reagent in pharmacokinetic, metabolic, and toxicological research related to Droperidol.
• Quality Assurance/Quality Control (QA/QC): Used as a system suitability standard and for routine batch analysis in pharmaceutical QC laboratories to ensure product purity and safety.

Basic Information

Product Name	Droperidol Impurity B
CAS No.	1026015-45-1
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 B; Droperidol EP Impurity B; Droperidol USP Impurity B; 4'-Fluoro-4-[4-(2-oxo-2,3-dihydro-1H-benzimidazol-1-yl)-1-piperidinyl]butyrophenone
EINECS	Contact for details

Quality Control

Every batch of Droperidol Impurity B is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC and NMR to ensure compliance with pharmacopeial standards (e.g., USP, EP). A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to guarantee traceability and reliability for your critical applications.

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 product 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 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 individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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