Description

Amifostine Related Impurities 2 CAS NO 17002-55-0 is a high-purity reference standard used for the analytical profiling and quality control of the cytoprotective drug Amifostine. This compound is critical for pharmaceutical manufacturers and research laboratories to ensure product safety, monitor degradation pathways, and comply with stringent regulatory requirements for impurity identification and quantification. It is an essential material for method development, validation, and stability studies in the production of Amifostine and related pharmaceutical formulations.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the quality control of Amifostine active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Used to develop, calibrate, and validate HPLC, UPLC, and LC-MS methods for accurate impurity detection and quantification.
• Stability and Forced Degradation Studies: Employed to identify and monitor degradation products formed under various stress conditions (e.g., heat, light, humidity) to establish shelf life.
• Regulatory Compliance & Documentation: Essential for generating regulatory submission documents (e.g., for FDA, EMA) by providing definitive impurity characterization data.
• Pharmacological Research: Serves as a tool in research to study the metabolism, pharmacokinetics, and potential toxicity profiles of Amifostine and its related compounds.
• Contract Research & Testing Laboratories (CRO/CTL): Used as a benchmark in third-party testing services to ensure batch-to-batch consistency and purity for clients.

Basic Information

Product Name	Amifostine Related Impurities 2
CAS No.	17002-55-0
Molecular Formula	C5H15N2O3PS2
Molecular Weight	246.29 g/mol
Synonyms	WR-1065 Disulfide; S-2-(3-Aminopropylamino)ethyl dihydrogen phosphorothioate disulfide; Ethiofos Impurity; Gammaphos Impurity; Amifostine Degradant; Amifostine Metabolite; AEBSH Disulfide; 2-[(3-Aminopropyl)amino]ethanethiol dihydrogen phosphate ester disulfide
EINECS	Contact for details

Quality Control

Every batch of Amifostine Related Impurities 2 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic (HPLC, UPLC) and spectroscopic (NMR, MS) techniques to ensure it meets the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing batch-specific results. Our quality processes support compliance with cGMP and ICH guidelines for impurities in drug substances.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability. For long-term storage, consider desiccant use and storage under inert atmosphere.

Specification

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