Description

Etomidate Impurity C Hcl is a high-purity reference standard critical for pharmaceutical research and development. This compound is essential for the analytical characterization and quality control of the anesthetic agent Etomidate, ensuring product safety and regulatory compliance. It is primarily used by analytical chemists, quality assurance professionals, and researchers in pharmaceutical companies and contract research organizations (CROs) for method development, validation, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Etomidate Impurity C in active pharmaceutical ingredient (API) batches.
• Analytical Method Development: Used in developing and validating HPLC, UPLC, and GC methods for impurity detection and separation.
• Quality Control & Assurance (QC/QA): Critical for routine testing in pharmaceutical manufacturing to monitor impurity levels and ensure they remain within ICH guidelines.
• Stability Studies: Employed as a marker in forced degradation and long-term stability studies of Etomidate drug substances and products.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Used in metabolic and pharmacokinetic studies to understand the degradation pathways of Etomidate.

Basic Information

Product Name	Etomidate Impurity C Hcl
CAS No.	66512-39-8
Molecular Formula	C15H17N2O3•HCl
Molecular Weight	300.77 g/mol (Free base: 265.31 g/mol)
Synonyms	1-(1-Phenylethyl)-1H-imidazole-5-carboxylic Acid Ethyl Ester Hydrochloride; Ethyl 1-(1-Phenylethyl)-1H-imidazole-5-carboxylate Hydrochloride; Etomidate Related Compound C; Etomidate EP Impurity C; Etomidate USP Impurity C; Etomidate Process Impurity C
EINECS	Contact for details

Quality Control

Every batch of Etomidate Impurity C Hcl is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, NMR, and MS to ensure compliance with pharmacopeial standards (e.g., USP, EP). 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 a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator after opening 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)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

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