Description

Etomidate Impurity 1 CAS NO 844658-92-0 is a high-purity reference standard critical for pharmaceutical research and development. This compound is essential for the accurate identification, quantification, and control of process-related impurities in the synthesis of Etomidate, a short-acting intravenous anesthetic agent. It is primarily required by analytical laboratories, quality control units, and R&D departments within the pharmaceutical and fine chemical industries to ensure drug safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for method development and validation in HPLC, GC, and LC-MS analysis.
• Impurity Profiling: Used to establish impurity profiles and monitor levels of this specific impurity during Etomidate Active Pharmaceutical Ingredient (API) manufacturing.
• Quality Control & Assurance: Critical for routine batch release testing of Etomidate to ensure it meets stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDA).
• Stability Studies: Employed as a marker to track impurity formation in Etomidate formulations under various stress and storage conditions.
• Process Chemistry Research: Aids chemists in optimizing synthetic routes to minimize the formation of this impurity, improving overall yield and purity.

Basic Information

Item	Details
Product Name	Etomidate Impurity 1
CAS No.	844658-92-0
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 A; Etomidate EP Impurity A; Etomidate USP Impurity; R-(+)-Etomidate Carboxylic Acid Impurity; 5-Carboxy-1-(1-phenylethyl)imidazole
EINECS	Contact for details

Quality Control

Every batch of Etomidate Impurity 1 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced analytical techniques like HPLC, GC-MS, and NMR to ensure compliance with pharmacopeial standards and customer-specific requirements. A comprehensive Certificate of Analysis (COA) detailing purity, chromatographic data, and spectroscopic confirmation 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 under inert atmosphere to ensure maximum stability.

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 single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w

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