Description

Sorafenib Impurity Int-1-D is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient Sorafenib, a multi-kinase inhibitor. It is primarily required by pharmaceutical companies, contract research organizations (CROs), and analytical laboratories engaged in method development, stability studies, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Sorafenib drug substance and drug product batches.
• Analytical Method Development & Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity detection.
• Stability Studies: Employed to monitor the formation and levels of this impurity during forced degradation and long-term stability testing of Sorafenib formulations.
• Quality Control (QC) Testing: Essential for routine in-process and release testing in GMP manufacturing environments to ensure batch-to-batch consistency and purity.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to define impurity limits and justify specifications.
• Research & Development: Used in R&D to study the degradation pathways and chemistry of Sorafenib.

Basic Information

Product Name	Sorafenib Impurity Int-1-D
CAS No.	1446410-29-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Sorafenib Intermediate Impurity D; Sorafenib Related Compound Int-1-D; 4-(4-Aminophenoxy)-N-methylpicolinamide derivative (Sorafenib related); Int-1-D (Sorafenib); Sorafenib Nitro Impurity; Sorafenib Process Impurity; BA 43-9006 Impurity Int-1-D; Nexavar Impurity Int-1-D
EINECS	Contact for details

Quality Control

Our Sorafenib Impurity Int-1-D is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including chromatographic purity assay and identity confirmation, to ensure it meets the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment to support your quality and regulatory needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w

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