Description

Ethanediamide Impurity D is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of pharmaceutical products and active pharmaceutical ingredients (APIs). It is primarily required by analytical laboratories and R&D departments in the pharmaceutical and fine chemical industries for method development, validation, and quality control testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Ethanediamide (Oxamide) and its derivative APIs.
• Analytical Method Development: Essential for developing and validating chromatographic methods (HPLC, GC) to monitor impurity profiles in drug substances.
• Quality Control & Assurance: Serves as a system suitability and calibration standard in QC laboratories to ensure the accuracy and precision of analytical results.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Research & Development: Utilized in stability studies, degradation pathway elucidation, and synthetic process optimization to understand and control impurity formation.
• Chemical Synthesis Monitoring: Acts as a marker to monitor reaction completeness and purity during the synthesis of Ethanediamide and related compounds.

Basic Information

Product Name	Ethanediamide Impurity D
CAS No.	480452-36-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Oxamide Impurity D; Ethanedioic acid diamide impurity D; 480452-36-6; Oxalamide Impurity D; Related Compound D of Oxamide; Ethanediamide Related Substance D; Analytical Standard of Oxamide Impurity
EINECS	Contact for details

Quality Control

Our Ethanediamide Impurity D is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including chromatographic purity and identity confirmation, to ensure it meets the high standards required for reference materials. A detailed Certificate of Analysis (COA) providing batch-specific data is supplied with every shipment.

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.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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