Description

Droperidol Impurity C is a designated pharmaceutical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the purity, safety, and efficacy of the antipsychotic drug Droperidol by serving as a key marker for identification and quantification during manufacturing and regulatory testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, development, and quality assurance of active pharmaceutical ingredients (APIs).

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the calibration of analytical instruments and validation of testing methods.
• Quality Control & Assurance (QC/QA): Used in the identification and quantification of related substances in Droperidol API and finished drug products to meet pharmacopeial requirements (e.g., USP, EP).
• Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or GC methods for impurity profiling.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing definitive impurity characterization data.
• Stability Studies: Employed as a benchmark to monitor the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity).
• Research & Development: Used in synthetic chemistry research to study degradation pathways and to develop purification processes for Droperidol.

Basic Information

Product Name	Droperidol Impurity C
CAS No.	60373-76-4
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 C; Droperidol EP Impurity C; Droperidol USP Impurity C; 1,3-Dihydro-1-[1-[4-(4-fluorophenyl)-4-oxobutyl]-1,2,3,6-tetrahydro-4-pyridinyl]-2H-benzimidazol-2-one; Droperidol Degradant; Droperidol Process Impurity
EINECS	Contact for details

Quality Control

Our Droperidol Impurity C is manufactured under strict quality systems to ensure high purity and batch-to-batch consistency suitable for use as a reference standard. Each batch is fully characterized and undergoes rigorous analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. A comprehensive Certificate of Analysis (COA) is provided, detailing all test results and confirming compliance with in-house specifications aligned with pharmacopeial expectations.

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

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

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