Description

Cobimetinib Impurity 3 is a designated impurity of the targeted cancer therapy Cobimetinib, used in pharmaceutical research and development. This high-purity reference standard is critical for analytical method development, stability studies, and ensuring the safety and efficacy of the active pharmaceutical ingredient (API). It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for quality control and compliance purposes.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quantitative and qualitative analysis of Cobimetinib drug substance and drug products.
• Analytical Method Development and Validation: Essential for developing, validating, and calibrating chromatographic methods (e.g., HPLC, UPLC) to monitor impurity profiles.
• Stability Indicating Studies: Used to identify and quantify degradation products formed under various stress conditions (e.g., heat, light, humidity) during drug stability testing.
• Quality Control & Batch Release: A critical component in the quality control process to ensure Cobimetinib batches meet stringent purity specifications set by pharmacopeias (USP, EP).
• Regulatory Submissions: Provides necessary data and characterization for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity control.
• Process Chemistry Research: Used to study and optimize the synthetic pathway of Cobimetinib to minimize the formation of this specific impurity.

Basic Information

Product Name	Cobimetinib Impurity 3
CAS No.	1597407-58-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Cobimetinib Related Compound 3; GDC-0973 Impurity 3; MEK Inhibitor Impurity; XL518 Impurity; (S)-[3,4-Difluoro-2-(2-fluoro-4-iodophenylamino)phenyl][3-hydroxy-3-(piperidin-2-yl)azetidin-1-yl]methanone (proposed); Cobimetinib Process Impurity; Cobimetinib Degradant
EINECS	Contact for details

Quality Control

Every batch of Cobimetinib Impurity 3 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques such as HPLC, GC, MS, and NMR to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, cool, and well-ventilated area. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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