Description

Sunitinib Impurity 18 is a designated impurity reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient Sunitinib Malate. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a benchmark in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development, production, and quality assurance of oncology therapeutics.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Sunitinib Malate drug substance and drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating stability-indicating HPLC/UPLC methods in quality control laboratories.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for Chemistry, Manufacturing, and Controls (CMC) documentation.
• Stability Studies: Employed in forced degradation and long-term stability studies to monitor impurity profiles and ensure product shelf-life.
• Process Chemistry Research: Aids in the identification and control of process-related impurities during the synthesis and purification of Sunitinib.
• Quality Assurance/Quality Control (QA/QC): Serves as a system suitability test component and for routine batch release testing to meet pharmacopeial standards (USP, EP).

Basic Information

Product Name	Sunitinib Impurity 18
CAS No.	1348032-93-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Sunitinib Related Compound 18; Sunitinib Impurity R; Sunitinib EP Impurity G; Sunitinib USP Impurity; Sunitinib Malate Impurity 18; N-[2-(Diethylamino)ethyl]-5-[(Z)-(5-fluoro-2-oxo-1H-indol-3-ylidene)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide (proposed); Tyrosine kinase inhibitor impurity
EINECS	Contact for details

Quality Control

Our Sunitinib Impurity 18 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity determination and spectroscopic identification (NMR, 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 our quality systems support compliance with cGMP and relevant ICH guidelines.

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 Certificate of Analysis. Keep the container in a dry, cool, and well-ventilated area.

Specification

Item	Specification
Appearance	Off-white to light yellow solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Complies with specification
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.