Description

Belinostat Impurity E is a specified impurity and degradation product of the histone deacetylase inhibitor Belinostat. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control. It is essential for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) during manufacturing and stability studies. This high-purity material is primarily utilized by analytical laboratories, pharmaceutical R&D teams, and quality assurance departments within the pharmaceutical and biotechnology industries.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Belinostat-related impurities in drug substance and drug product analysis.
• Analytical Method Development & Validation: Critical for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Assurance: Employed in routine QC testing to ensure Belinostat API and finished drug products meet stringent ICH guidelines for impurity thresholds.
• Stability Studies: Used to identify and track degradation products formed under various stress conditions (e.g., heat, light, humidity) as per ICH Q1A(R2).
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity limits and justify the control strategy.
• Process Chemistry Research: Aids in understanding the formation pathways of this impurity during API synthesis, helping to optimize manufacturing processes.

Basic Information

Item	Details
Product Name	Belinostat Impurity E
CAS No.	1576-45-0
Molecular Formula	C15H14N2O4S
Molecular Weight	318.35 g/mol
Synonyms	PXD101 Impurity E; N-Hydroxy-4-((2-(phenylsulfonyl)ethyl)amino)methyl)benzamide; Belinostat Related Compound E; (E)-N-Hydroxy-4-(((2-(phenylsulfonyl)ethyl)amino)methyl)cinnamamide; 4-[[[2-(Phenylsulfonyl)ethyl]amino]methyl]-N-hydroxybenzamide; PXD-101 Impurity E
EINECS	Contact for details

Quality Control

Every batch of Belinostat Impurity E is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic (HPLC, UPLC) and spectroscopic (MS, NMR) techniques to ensure compliance with ICH Q3A/B guidelines and customer-specific requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, assay, and related substances.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. For long-term storage, consider storing at 2-8°C. The material is moisture-sensitive; keep the container tightly sealed in a dry place.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
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.