Description

Sunitinib Impurity 20 is a designated impurity of the active pharmaceutical ingredient Sunitinib, a multi-targeted receptor tyrosine kinase inhibitor. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, stability studies, and regulatory compliance. It is essential for quality control laboratories and R&D teams in the pharmaceutical industry who require high-purity chemical reference materials to ensure drug safety and efficacy. The product is supplied with comprehensive analytical data to support its use in method validation and impurity profiling.

Application

• Primary use as a Pharmaceutical Reference Standard for the identification and quantification of impurities in Sunitinib drug substance and drug products.
• Critical component in Analytical Method Development and Validation (HPLC, UPLC, LC-MS) for impurity profiling.
• Used in Stability Studies and forced degradation studies to understand the degradation pathways of Sunitinib.
• Essential for Quality Control and Assurance processes to monitor impurity levels and ensure batch-to-batch consistency.
• Serves as a Research Chemical in metabolic and pharmacokinetic studies related to Sunitinib.
• Supports regulatory filings (e.g., ANDA, NDA) by providing necessary impurity data for submission to authorities like the FDA and EMA.

Basic Information

Product Name	Sunitinib Impurity 20
CAS No.	879274-72-3
Molecular Formula	C22H27FN4O2
Molecular Weight	398.48 g/mol
Synonyms	Sunitinib Related Compound 20; Sunitinib Impurity C; N-[2-(Diethylamino)ethyl]-5-[(Z)-(5-fluoro-2-oxo-1H-indol-3-ylidene)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide; SU11248 Impurity 20; (Z)-N-(2-(Diethylamino)ethyl)-5-((5-fluoro-2-oxo-1H-indol-3(2H)-ylidene)methyl)-2,4-dimethyl-1H-pyrrole-3-carboxamide
EINECS	Contact for details

Quality Control

Every batch of Sunitinib Impurity 20 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC purity determination and structural confirmation (NMR, MS), to ensure compliance with the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for identity, purity, and impurities. We support compliance with ICH guidelines for impurities in new drug substances.

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 material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	Off-white to yellow solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH limits

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