Description

Etomidate Impurity 15 is a designated process-related impurity and reference standard used in the pharmaceutical development and quality control of the anesthetic agent Etomidate. This high-purity analytical standard is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification, quantification, and control of this specific impurity. It is an essential material for analytical chemists, quality assurance professionals, and R&D scientists working in pharmaceutical manufacturing, contract research organizations (CROs), and regulatory testing laboratories.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the qualitative and quantitative analysis of Etomidate drug substance and finished products.
• Method Development and Validation: Critical for developing and validating stability-indicating analytical methods, such as HPLC and LC-MS, for impurity profiling.
• Quality Control & Batch Release: Used in routine QC testing to monitor and control the level of Etomidate Impurity 15 to ensure it remains within specified ICH guidelines.
• Stability Studies: Employed to identify and track the formation of this impurity under various stress conditions (heat, light, humidity) as part of drug stability programs.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough understanding and control of the drug's impurity profile.
• Process Chemistry Research: Aids in optimizing synthetic routes and purification processes to minimize the formation of this specific impurity.

Basic Information

Product Name	Etomidate Impurity 15
CAS No.	2374709-47-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Etomidate Related Compound 15; Etomidate EP Impurity C; Etomidate USP Impurity; 1-(1-Phenylethyl)-1H-imidazole-5-carboxylic acid ethyl ester (proposed); Etomidate Process Impurity; Anesthetic Impurity Standard; R-(+)-Etomidate Impurity; CG-635 Impurity
EINECS	Contact for details

Quality Control

Every batch of Etomidate Impurity 15 is manufactured and controlled under a strict quality management system. The product undergoes rigorous analytical testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and strength conform to the highest standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting compliance with ICH Q3A/B, USP, and EP guidelines for impurities in new drug substances and products.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or Certificate of Analysis. Keep the container in a dry, cool, and well-ventilated area. For long-term storage, consider storing under inert atmosphere to preserve stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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