Description

Vorinostat Impurity CAS NO 866824-87-5 is a designated chemical reference standard used in the analytical profiling of the active pharmaceutical ingredient Vorinostat. This impurity is critical for ensuring the safety and efficacy of the final drug product by enabling accurate identification and quantification of related substances. It is an essential material for pharmaceutical R&D and quality control laboratories focused on method development, validation, and regulatory compliance.

Application

• Pharmaceutical Impurity Reference Standard: Primary use as a certified reference material for the identification and quantification of impurities in Vorinostat (SAHA) API and finished drug products.
• Analytical Method Development & Validation: Critical for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods in accordance with ICH Q2(R1) and Q3A(R2) guidelines.
• Quality Control & Batch Release Testing: Used as a system suitability standard and for setting impurity acceptance criteria in routine QC testing of commercial batches.
• Stability Studies: Employed to monitor impurity profiles during forced degradation and long-term stability studies of Vorinostat formulations.
• Regulatory Submissions: Provides necessary data on impurity structure, characterization, and toxicological thresholds for FDA, EMA, and other global regulatory filings.
• Research on Degradation Pathways: Aids in understanding the chemical degradation mechanisms of Vorinostat under various stress conditions.

Basic Information

Product Name	Vorinostat Impurity
CAS No.	866824-87-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	SAHA Related Compound; Vorinostat Related Substance; Suberoylanilide Hydroxamic Acid Impurity; (2E)-N-Hydroxy-7-[(4-aminophenyl)amino]-2,4,6-heptatrienamide; Vorinostat Degradation Product; Histone Deacetylase Inhibitor Impurity; HDAC Inhibitor Impurity
EINECS	Contact for details

Quality Control

Our Vorinostat Impurity is manufactured under strict quality systems. Each batch undergoes comprehensive analytical characterization using advanced techniques such as HPLC, LC-MS, NMR, and IR to confirm identity and purity. A detailed Certificate of Analysis (COA) is provided, which includes batch-specific data on purity, related substances, and residual solvents, ensuring compliance with ICH guidelines and supporting your regulatory needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or an inert atmosphere.

Specification

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