Description

Ethanediamide Impurity F is a high-purity chemical 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 utilized by research institutions, analytical laboratories, and quality assurance departments within the pharmaceutical industry for method development and validation.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the analysis of Ethanediamide (Oxamide) and related drug substances.
• Method Development and Validation: Essential for developing and validating chromatographic methods (HPLC, UPLC) to monitor impurities in active pharmaceutical ingredients (APIs).
• Quality Control (QC) Testing: Used in routine QC testing of pharmaceutical batches to ensure compliance with ICH Q3A/B guidelines on impurities.
• Stability Studies: Employed as a marker compound in forced degradation and long-term stability studies of drug products.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate control over the drug substance impurity profile.
• Research and Development: Supports synthetic chemistry research and impurity profiling during the drug development process.

Basic Information

Product Name	Ethanediamide Impurity F
CAS No.	480452-37-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Oxamide Impurity F; Oxalamide Impurity F; Ethanedioic acid diamide impurity; Related Substance F of Oxamide; 480452-37-7; Oxamide Related Compound F
EINECS	Contact for details

Quality Control

Our Ethanediamide Impurity F is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity analysis and structural confirmation, to ensure it meets the high standards required for a reference material. A comprehensive Certificate of Analysis (COA) detailing identity, purity, and assay is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This product is light-sensitive and should be handled accordingly to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 0.5% Total impurities ≤ 2.0%
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.