Description

Sunitinib Impurity 61 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 reference standard for analytical method development, validation, and quality control processes. It is essential for laboratories in the pharmaceutical and biotechnology sectors focused on ensuring the purity, safety, and regulatory compliance of Sunitinib-based drug products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Sunitinib Malate API and finished drug products.
• Analytical Method Development: Critical for developing and validating sensitive HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Used in routine batch testing in pharmaceutical manufacturing to ensure compliance with ICH Q3A/B guidelines on impurities.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs).
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity).
• Research & Development: Facilitates process chemistry optimization by identifying and controlling synthetic by-products.

Basic Information

Product Name	Sunitinib Impurity 61
CAS No.	100487-78-3
Molecular Formula	C22H27FN4O2
Molecular Weight	398.48 g/mol
Synonyms	Sunitinib Related Compound 61; Sunitinib Impurity F; 5-[5-Fluoro-2-oxo-1,2-dihydro-3H-indol-3-ylidene)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxylic Acid (2-Diethylaminoethyl)amide; N-[2-(Diethylamino)ethyl]-5-[(5-fluoro-2-oxo-1H-indol-3-ylidene)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide; SU11248 Impurity 61
EINECS	Contact for details

Quality Control

Every batch of Sunitinib Impurity 61 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. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the material should be handled in a low-humidity environment and the container kept tightly sealed after each use to prevent moisture absorption.

Specification

Item	Specification
Appearance	Yellow to orange solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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