Description

Amifostine Impurity 8 is a designated reference standard used in the analytical profiling and quality control of the pharmaceutical agent Amifostine. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) by serving as a key marker in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and routine batch testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Amifostine Impurity 8 in Amifostine API and finished drug products.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles in compliance with ICH guidelines.
• Quality Control & Assurance: Employed in routine QC testing of Amifostine batches to ensure impurity levels remain within specified safety thresholds.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug master files.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Research & Development: Facilitates research into the degradation pathways and metabolism of Amifostine.

Basic Information

Product Name	Amifostine Impurity 8
CAS No.	66487-25-0
Molecular Formula	C5H15N2O3PS
Molecular Weight	214.22 g/mol
Synonyms	WR-1065 Disulfide; S-2-(3-Aminopropylamino)ethyl dihydrogen phosphorothioate disulfide; 2-[(3-Aminopropyl)amino]ethanethiol dihydrogen phosphate ester disulfide; Amifostine Disulfide Impurity; Ethiofos Impurity; Gammaphos Impurity; Amifostine Related Compound 8
EINECS	Contact for details

Quality Control

Every batch of Amifostine Impurity 8 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic and spectroscopic techniques (HPLC, MS, NMR) to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

Storage

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

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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