Description

Etomidate Impurity 20 is a specified impurity of the anesthetic agent Etomidate, identified by the CAS registry number 112421-33-7. This compound is critical for pharmaceutical research and development, serving as a key reference standard in the analytical characterization and quality control of Etomidate drug substances and products. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure product purity, safety, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Etomidate Impurity 20 in active pharmaceutical ingredients (APIs) and finished drug products.
• Method Development & Validation: Essential for developing and validating sensitive analytical methods, such as HPLC and LC-MS, to monitor impurities during the drug manufacturing process.
• Quality Control & Assurance: A critical component in routine QC testing to ensure Etomidate batches meet the specified impurity limits as per ICH Q3A/B guidelines and pharmacopeial monographs (USP, EP).
• Stability Studies: Employed in forced degradation and long-term stability studies to track the formation of this impurity and establish the shelf-life of Etomidate formulations.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate thorough impurity profiling and control strategies to agencies like the FDA and EMA.
• Research & Synthesis: Used by synthetic chemists to study the degradation pathways of Etomidate and to develop improved synthetic routes with lower impurity profiles.

Basic Information

Item	Details
Product Name	Etomidate Impurity 20
CAS No.	112421-33-7
Molecular Formula	C14H16N2O2
Molecular Weight	244.29 g/mol
Synonyms	1-(1-Phenylethyl)-1H-imidazole-5-carboxylic acid; Ethyl 1-(1-phenylethyl)-1H-imidazole-5-carboxylate (related ester); Etomidate Related Compound; Etomidate Degradant; Etomidate Process Impurity; R-(+)-Etomidate Impurity; (R)-1-(1-Phenylethyl)-1H-imidazole-5-carboxylic acid
EINECS	Contact for details

Quality Control

Every batch of Etomidate Impurity 20 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure the highest standards of identity, purity, and stability. Our quality system is designed to meet the exacting requirements of pharmaceutical impurity standards, with testing typically including HPLC for assay and related substances, IR and MS for identification, and KF for water content. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing all test results against predefined specifications.

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 under inert conditions or in a desiccator to prevent degradation upon absorption of atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
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.