Description

Sunitinib Impurity 58 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 and manufacturers in the pharmaceutical industry who require high-purity chemical reference materials to ensure drug safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Sunitinib drug substance and finished products.
• Analytical Method Development: Crucial for developing and optimizing chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance: Used in routine batch testing to monitor impurity levels and ensure drug product specifications are met according to ICH guidelines.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity characterization data for drug master files.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions to establish shelf-life.
• Research & Development: Used in metabolic and pharmacokinetic studies to understand the impurity's behavior and potential impact.

Basic Information

Item	Details
Product Name	Sunitinib Impurity 58
CAS No.	856436-17-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Sunitinib Related Compound 58
Sunitinib Impurity RRT 0.58
Sunitinib EP Impurity H
Sunitinib USP Impurity
Sutent Impurity 58
N-[2-(Diethylamino)ethyl]-5-[(Z)-(5-fluoro-2-oxo-1H-indol-3-ylidene)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide (Potential IUPAC-based name)
856436-17-4
EINECS	Contact for details

Quality Control

Every batch of Sunitinib Impurity 58 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with industry standards for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile is provided with each shipment to support your regulatory and research needs.

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 compound is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	Off-white to light yellow solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
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.