Description

Ethacrynic Acid Impurity B is a high-purity reference standard critical for analytical method development and quality control in pharmaceutical manufacturing. This compound serves as a key impurity marker, essential for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient, Ethacrynic Acid. It is primarily required by pharmaceutical R&D laboratories, quality assurance departments, and contract research organizations (CROs) involved in the production and analysis of diuretic medications.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Ethacrynic Acid drug substance and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, or GC methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to ensure drug products meet stringent pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Used to track the formation and level of this specific degradation product under various stress conditions.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND), and new drug application (NDA) submissions to agencies like the FDA and EMA.
• Research & Development: Facilitates studies on the degradation pathways and metabolism of Ethacrynic Acid.

Basic Information

Product Name	Ethacrynic Acid Impurity B
CAS No.	95772-54-6
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; Ethacrynic Acid EP Impurity B; Ethacrynic Acid Related Compound B; Ethacrynic Acid USP Impurity B; Edecrin Impurity B
EINECS	Contact for details

Quality Control

Every batch of Ethacrynic Acid Impurity B is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical characterization using techniques such as HPLC, NMR, and MS to ensure identity, purity, and traceability. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing all test results against established in-house specifications aligned with ICH guidelines. We support compliance with cGMP, USP, and EP standards for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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