Description

Sunitinib Impurity 60 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, validation, and quality control processes. It is primarily utilized by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories to ensure the purity, safety, and efficacy of Sunitinib-based drug products. The availability of a well-characterized impurity standard is essential for meeting stringent regulatory requirements for drug substance and drug product filings.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Sunitinib active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC/LC-MS methods to monitor impurity profiles during stability studies and manufacturing.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to ensure Sunitinib drug substances and products comply with pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines on impurities.
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., CMC sections for FDA, EMA) by providing necessary impurity characterization data.
• Stability Studies: Acts as a marker to track potential degradation pathways of Sunitinib under various stress conditions (e.g., heat, light, humidity).
• Process Chemistry Research: Used to study and optimize synthetic routes for Sunitinib to minimize the formation of this specific impurity.

Basic Information

Product Name	Sunitinib Impurity 60
CAS No.	17120-26-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Sunitinib Related Compound 60; Sunitinib Impurity R; Sunitinib EP Impurity G; Sunitinib USP Impurity; (Z)-N-[2-(Diethylamino)ethyl]-5-[(5-fluoro-2-oxo-1H-indol-3-ylidene)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide; SU11248 Impurity 60; Sutent Impurity 60
EINECS	Contact for details

Quality Control

Our Sunitinib Impurity 60 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure the highest standards of identity, purity, and quality. Each batch is characterized using advanced techniques such as HPLC, LC-MS, NMR, and IR spectroscopy. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, assay, and related substances. Our quality system is designed to support pharmaceutical research and regulatory compliance, aligning with ICH and cGMP principles where applicable.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The product is light-sensitive and should be handled under appropriate conditions to maintain stability. For long-term storage, consider storing desiccated at 2-8°C.

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)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
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.