Description

Vorinostat Impurity 3 CAS NO 1305124-48-4 is a high-purity reference standard specifically identified as a process-related impurity of the active pharmaceutical ingredient Vorinostat (SAHA). This compound is critical for pharmaceutical research and development, enabling accurate identification, quantification, and control of impurities during drug manufacturing. It is an essential material for analytical chemists and quality control laboratories in the pharmaceutical industry, supporting method validation, stability studies, and regulatory compliance for oncology drug products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the qualitative and quantitative analysis of Vorinostat (SAHA) and related drug substances.
• Analytical Method Development & Validation (HPLC/LC-MS): Used to develop, optimize, and validate chromatographic methods for impurity profiling and assay determination.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine batch testing to ensure drug substance and product purity meets pharmacopeial specifications (e.g., ICH Q3A/B).
• Stability Studies: Employed to monitor the formation and levels of this specific impurity under various stress conditions (heat, light, humidity) as part of forced degradation and shelf-life studies.
• Regulatory Documentation & Submission: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds, justify specifications, and demonstrate control of the manufacturing process.
• Research on Degradation Pathways: Aids in understanding the chemical degradation mechanisms of Vorinostat, supporting the development of more stable formulations.

Basic Information

Product Name	Vorinostat Impurity 3
CAS No.	1305124-48-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	SAHA Impurity 3; Vorinostat Related Compound 3; Suberoylanilide Hydroxamic Acid Impurity 3; (2E)-N-Hydroxy-7-(4-(phenylamino)phenyl)hept-2-en-6-ynamide; Zolinza Impurity 3; IUPAC Name: Contact for details
EINECS	Contact for details

Quality Control

Every batch of Vorinostat Impurity 3 is manufactured and handled under strict quality management systems. The material undergoes comprehensive analytical testing, including advanced chromatographic (HPLC, UPLC) and spectroscopic (MS, NMR) techniques, to confirm identity and ensure high purity suitable for use as a reference standard. A detailed Certificate of Analysis (COA) is provided with each lot, documenting purity, assay, and impurity profile. Our quality commitment aligns with the standards expected for pharmaceutical research materials.

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 product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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