Description

Sorafenib Impurity 35 is a designated pharmaceutical reference standard used in the quality control and analytical development of the active pharmaceutical ingredient (API) Sorafenib. This impurity is critical for ensuring the purity, safety, and efficacy of the final drug product by enabling accurate identification and quantification during manufacturing. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in the development and production of Sorafenib, a kinase inhibitor used in cancer therapy.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the calibration of analytical equipment and validation of testing methods.
• Method Development & Validation: Essential for developing and validating HPLC, UPLC, and LC-MS methods to monitor and control impurity profiles.
• Quality Control (QC) Testing: Used in routine batch release testing of Sorafenib API to ensure compliance with pharmacopeial limits (e.g., ICH Q3A/B).
• Stability Studies: Employed to identify and track the formation of this specific impurity in Sorafenib formulations under various storage conditions.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to establish impurity specifications and justify safety thresholds.
• Research & Development: Supports process chemistry research to understand impurity formation pathways and optimize synthesis routes for cleaner API production.

Basic Information

Product Name	Sorafenib Impurity 35
CAS No.	864272-34-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	N-Methyl-N-[4-(4-methylpiperazin-1-yl)phenyl]-4-[[4-(pyridin-3-yl)pyrimidin-2-yl]amino]benzamide; Sorafenib N-Methyl Metabolite Impurity; BAY 43-9006 Impurity 35; Sorafenib Related Compound 35; 4-[4-[[4-(3-Pyridinyl)-2-pyrimidinyl]amino]phenyl]-N-methyl-N-(4-methyl-1-piperazinyl)benzamide
EINECS	Contact for details

Quality Control

Our Sorafenib Impurity 35 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and structural characterization via NMR and MS, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant guidelines.

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 compound is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (MS)	Consistent with molecular structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%

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