Description

Ethanediamide Impurity F Hcl 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 by serving as a well-characterized impurity marker. It is primarily needed by analytical laboratories, quality control units, and research scientists in the pharmaceutical and biotechnology industries for method development, validation, and stability testing.

Application

• Pharmaceutical Impurity Profiling and Identification in Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Analytical Method Development and Validation for HPLC, UPLC, and LC-MS techniques.
• Quality Control and Stability Studies to monitor impurity levels and ensure batch-to-batch consistency.
• Regulatory Compliance and Documentation for submissions to agencies like the FDA, EMA, and ICH.
• Research and Development of new synthetic routes and degradation pathway studies.
• Calibration Standard for quantitative analysis in contract research organizations (CROs) and testing laboratories.

Basic Information

Product Name	Ethanediamide Impurity F Hcl
CAS No.	482375-18-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Oxalamide Impurity F Hydrochloride; Ethanediamide Related Compound F HCl; N,N'-Dihydroxyoxalamide Impurity F HCl; Oxamic Acid Diamide Impurity F Hydrochloride; 482375-18-8; UNII-Contact for details
EINECS	Contact for details

Quality Control

Our Ethanediamide Impurity F Hcl is manufactured under strict quality systems to ensure it meets the exacting standards required for pharmaceutical reference materials. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles, aligning with ICH Q3A/B guidelines. We ensure traceability, stability, and reliability for all our reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.1%

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