Description

Etacrynic Acid Ep Impurity B is a high-purity chemical reference standard, specifically identified as a known impurity of the active pharmaceutical ingredient Etacrynic Acid. This compound is critical for ensuring the quality, safety, and efficacy of pharmaceutical products by enabling accurate identification and quantification of impurities during method development and routine quality control testing. It is an essential material for analytical laboratories and manufacturers in the pharmaceutical industry focused on compliance with stringent pharmacopeial standards such as the European Pharmacopoeia (EP).

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the analysis of Etacrynic Acid and related pharmaceutical formulations.
• Analytical Method Development & Validation (HPLC/LC-MS): Used to develop, optimize, and validate chromatographic methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Serves as a system suitability and identification marker in the routine batch testing of active pharmaceutical ingredients (APIs).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., CMC sections) by providing data for impurity identification as per ICH Q3A/B guidelines.
• Stability Studies: Employed to monitor the formation of degradation products in stability testing programs for Etacrynic Acid.
• Research & Development: Used in pharmaceutical R&D for studying the degradation pathways and metabolism of Etacrynic Acid.

Basic Information

Product Name	Etacrynic Acid Ep Impurity B
CAS No.	27929-18-6
Molecular Formula	C13H12Cl2O4
Molecular Weight	303.14 g/mol
Synonyms	2,3-Dichloro-4-(2-ethylacryloyl)phenoxyacetic Acid; (2,3-Dichloro-4-(2-methylidenebutanoyl)phenoxy)acetic Acid; Etacrynic Acid Impurity B; Edecrin Impurity B; Etacrynic Acid Related Compound B; 4-(2,3-Dichlorophenoxy)-3-oxopentanoic Acid Derivative
EINECS	Contact for details

Quality Control

Every batch of Etacrynic Acid Ep Impurity B is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including advanced chromatographic techniques, to ensure identity, purity, and compliance with high-grade reference standard specifications. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided and traceable to pharmacopeial standards where applicable.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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