Description

Etomidate Impurity 17 is a designated reference standard used in the analytical profiling and quality control of the anesthetic agent Etomidate. This compound is critical for pharmaceutical manufacturers and research laboratories to ensure product purity, safety, and regulatory compliance. It is primarily utilized in the development and validation of analytical methods for identifying and quantifying related substances in Etomidate Active Pharmaceutical Ingredients (APIs) and finished drug products.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the qualitative and quantitative analysis of Etomidate.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, and GC methods in R&D and QC laboratories.
• Quality Assurance & Control (QA/QC): Used to monitor and control impurity levels during the synthesis and purification of Etomidate API to meet pharmacopeial standards (e.g., USP, EP).
• Stability Studies: Employed as a marker to track the formation of degradation products in Etomidate formulations under various storage conditions.
• Regulatory Compliance & Documentation: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity characterization.
• Research on Metabolism & Degradation Pathways: Aids in studies investigating the metabolic fate and stability profile of Etomidate.

Basic Information

Item	Details
Product Name	Etomidate Impurity 17
CAS No.	81591-23-3
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; Etomidate Related Compound; Etomidate Impurity; Contact for additional synonyms.
EINECS	Contact for details

Quality Control

Every batch of Etomidate Impurity 17 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and strength testing using advanced chromatographic and spectroscopic techniques to ensure they meet the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing purity, assay results, and chromatographic data is provided with each shipment.

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 desiccants.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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