Description

Cobimetinib Impurity 2 CAS NO 1597407-56-1 is a specified impurity of Cobimetinib, a targeted cancer therapy used in combination treatments. This impurity is a critical reference standard for pharmaceutical research and development, essential for method validation, stability studies, and ensuring drug safety and efficacy. It is primarily required by analytical laboratories, quality control units, and R&D departments within the pharmaceutical and biotechnology industries to meet stringent regulatory requirements for impurity profiling and control.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Cobimetinib drug substance and drug products.
• Analytical Method Development and Validation: Essential for developing, validating, and verifying HPLC, UPLC, and LC-MS methods for impurity detection and separation.
• Stability Indicating Studies: Employed in forced degradation and long-term stability studies to identify and monitor impurity formation pathways in Cobimetinib formulations.
• Quality Control and Batch Release: Serves as a system suitability standard and for setting impurity acceptance criteria in the quality control testing of active pharmaceutical ingredients (APIs).
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity characterization and control strategies.
• Process Chemistry Research: Used to study and optimize synthetic routes by identifying and quantifying process-related impurities.

Basic Information

Product Name	Cobimetinib Impurity 2
CAS No.	1597407-56-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	GDC-0973 Impurity 2; XL518 Impurity 2; MEK Inhibitor Impurity; (S)-[3,4-Difluoro-2-(2-fluoro-4-iodophenylamino)phenyl][3-hydroxy-3-(piperidin-2-yl)azetidin-1-yl]methanone (related impurity); Cobimetinib Related Compound 2
EINECS	Contact for details

Quality Control

Every batch of Cobimetinib Impurity 2 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced chromatographic and spectroscopic techniques (e.g., HPLC, LC-MS, NMR) to ensure compliance with industry standards for reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator to prevent degradation. For long-term storage, consider storing at 2-8°C.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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