Description

Etomidate Impurity 7 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the anesthetic agent Etomidate. It is primarily required by pharmaceutical manufacturers, quality control laboratories, and research institutions involved in drug development and impurity profiling. The material is supplied with comprehensive analytical data to support method validation and regulatory submissions.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the quality control and release testing of Etomidate Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating chromatographic methods (HPLC, UPLC, GC) for impurity identification and quantification.
• Stability Studies: Employed to monitor the formation of this specific degradation product during forced degradation and long-term stability studies of Etomidate formulations.
• Regulatory Compliance & Documentation: Supports the preparation of regulatory filings (e.g., CMC sections for FDA, EMA) by providing definitive impurity characterization data.
• Research & Development: Used in pharmacokinetic, metabolic, and toxicological studies to understand the profile and impact of this impurity.
• Pharmacopoeial Testing: Serves as a system suitability and identification standard in compliance with pharmacopoeial monographs (e.g., USP, EP).

Basic Information

Product Name	Etomidate Impurity 7
CAS No.	2433776-55-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Etomidate Related Compound 7; Etomidate EP Impurity G; Etomidate USP Impurity; (R)-1-(1-phenylethyl)-1H-imidazole-5-carboxylic acid; Etomidate Degradation Product; Etomidate Process Impurity; Anesthetic Impurity Standard
EINECS	Contact for details

Quality Control

Every batch of Etomidate Impurity 7 is manufactured and controlled under a strict quality management system. The material undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, GC-MS, and NMR. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with in-house specifications aligned with ICH guidelines. Our quality commitment ensures reliability for your critical analytical and regulatory needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider desiccants or inert atmosphere.

Specification

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

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