Description

Givinostat Impurity 5 is a specified impurity associated with the active pharmaceutical ingredient Givinostat. 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 primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Givinostat drug substances and products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Givinostat API and finished drug products.
• Analytical Method Development: Essential for developing and validating chromatographic methods (e.g., HPLC, UPLC) to monitor impurity profiles.
• Quality Control & Assurance: A critical component in routine QC testing to ensure batch-to-batch consistency and compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing impurity characterization data.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions.
• Process Chemistry Research: Used to study and optimize synthetic pathways to minimize the formation of this specific impurity.

Basic Information

Product Name	Givinostat Impurity 5
CAS No.	58202-83-8
Molecular Formula	C25H27N3O4
Molecular Weight	433.50 g/mol
Synonyms	Givinostat Related Compound 5; Givinostat EP Impurity D; Givinostat USP Impurity; ITF2357 Impurity 5; (E)-N-Hydroxy-3-[4-[[(2-hydroxyethyl)[2-(1H-indol-3-yl)ethyl]amino]methyl]phenyl]acrylamide; Hydroxamic acid derivative impurity of Givinostat
EINECS	Contact for details

Quality Control

Every batch of Givinostat Impurity 5 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and strength testing to ensure compliance with pharmacopeial standards (USP/EP/ICH). A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from HPLC purity assay, related substances, residual solvents, and other critical tests.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is hygroscopic (moisture-sensitive); the container must be kept tightly sealed and stored under inert conditions if necessary to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Water Content (KF)	≤ 1.0%
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.