Description

Ethanediamide Impurity K CAS NO 2803419-58-9 is a high-purity reference standard used for analytical and quality control purposes. This compound is critical for ensuring the safety and efficacy of pharmaceutical products by enabling the accurate identification and quantification of related substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development and quality assurance of active pharmaceutical ingredients (APIs) and finished drug products.

Application

• Pharmaceutical Reference Standard for method development and validation.
• Quality Control (QC) testing of Ethanediamide (Oxamide) Active Pharmaceutical Ingredients (APIs).
• Impurity profiling and characterization studies in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability testing of drug substances and products to monitor degradation pathways.
• Calibration standard for analytical instrumentation such as HPLC, UPLC, and LC-MS.
• Research and Development (R&D) of synthetic pathways and purification processes.

Basic Information

Product Name	Ethanediamide Impurity K
CAS No.	2803419-58-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Oxamide Impurity K; Oxalamide Impurity K; Ethanedioic acid diamide impurity; Diamide of oxalic acid impurity; 1,2-Ethanediamide related compound K; Oxalic acid diamide impurity; Related Substance K of Ethanediamide
EINECS	Contact for details

Quality Control

Our products undergo rigorous quality testing to ensure compliance with industry standards. Certificates of Analysis (COA) are available upon request. This reference material is produced and controlled under a quality management system suitable for pharmaceutical applications, with testing typically including identification, purity assay, and related substances analysis.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as specified on the certificate of analysis. Keep the container in a dry, cool, and well-ventilated area.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unspecified impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C

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