Description

Sunitinib Impurity 1 is a designated impurity of the active pharmaceutical ingredient Sunitinib Malate, 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, analytical chemists, and pharmaceutical manufacturers involved in the production and validation of Sunitinib-based oncology therapeutics.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Sunitinib Malate drug substance and finished products.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, and LC-MS methods to ensure accurate impurity profiling.
• Stability Indicating Studies: Used to monitor the degradation pathways and stability of Sunitinib under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Quality Control & Batch Release: Employed in routine QC testing to ensure that Sunitinib batches meet stringent purity specifications and ICH guidelines.
• Research on Degradation Pathways: Facilitates research into the chemical behavior, metabolism, and degradation mechanisms of Sunitinib.

Basic Information

Product Name	Sunitinib Impurity 1
CAS No.	1467015-10-6
Molecular Formula	C₂₂H₂₇FN₄O₂
Molecular Weight	398.47 g/mol
Synonyms	Sunitinib Related Compound 1; Sunitinib Impurity A; N-[2-(Diethylamino)ethyl]-5-[(Z)-(5-fluoro-2-oxo-1H-indol-3-ylidene)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide; 5-[(Z)-(5-Fluoro-2-oxo-1,3-dihydroindol-3-ylidene)methyl]-2,4-dimethyl-N-(2-(diethylamino)ethyl)-1H-pyrrole-3-carboxamide; SU11248 Impurity 1
EINECS	Contact for details

Quality Control

Every batch of Sunitinib Impurity 1 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (HPLC, LC-MS, NMR) to ensure compliance with pharmacopeial standards and ICH Q3A/B guidelines. 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 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.

Specification

Item	Specification
Appearance	Off-white to yellow solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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