Description

Etomidate Impurity 19 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 serves as a key marker for identifying and quantifying related substances during the development and production of Etomidate-based formulations.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for analytical method development and validation.
• Quality Control & Assurance: Essential for monitoring and controlling impurity levels in Etomidate Active Pharmaceutical Ingredient (API) batches to meet pharmacopeial standards (e.g., USP, EP).
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing characterized impurity data.
• Stability Studies: Used as a benchmark to track the formation of degradation products in Etomidate formulations under various storage conditions.
• Research & Development: Facilitates synthetic route optimization and impurity fate mapping during the process development of Etomidate.
• Analytical Laboratory Calibration: Serves as a high-purity calibrant for techniques like HPLC, UPLC, and GC to ensure accurate impurity quantification.

Basic Information

Product Name	Etomidate Impurity 19
CAS No.	66512-38-7
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; Etomidate Related Compound; Etomidate EP Impurity; Etomidate USP Impurity; R-(+)-Etomidate carboxylic acid ethyl ester impurity
EINECS	Contact for details

Quality Control

Every batch of Etomidate Impurity 19 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced chromatographic and spectroscopic techniques to ensure compliance with industry standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

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)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.