Description

Sunitinib Impurity CAS NO 356068-98-9 is a specific chemical impurity associated with the active pharmaceutical ingredient Sunitinib Malate. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development and validation. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and quality control laboratories to ensure the purity, safety, and efficacy of Sunitinib-based drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Sunitinib Malate active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurity profiles during drug stability studies.
• Quality Control & Assurance: Employed in routine QC testing to ensure batch-to-batch consistency and compliance with stringent ICH Q3A(R2) and Q3B(R2) guidelines on impurities.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing impurity characterization data.
• Process Chemistry Research: Aids in understanding and controlling the formation of this impurity during the synthesis, purification, and scale-up of Sunitinib Malate.
• Stability Studies: Used to track the level of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.

Basic Information

Item	Details
Product Name	Sunitinib Impurity
CAS No.	356068-98-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Sunitinib Related Compound; Sunitinib Malate Impurity; Sunitinib Process Impurity; Sunitinib Degradant; 5-[5-Fluoro-2-oxo-1,2-dihydro-indol-(3Z)-ylidenemethyl]-2,4-dimethyl-1H-pyrrole-3-carboxylic acid (2-diethylamino-ethyl)-amide; N-[2-(Diethylamino)ethyl]-5-[(Z)-(5-fluoro-2-oxo-1H-indol-3-ylidene)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide
EINECS	Contact for details

Quality Control

Our Sunitinib Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis and spectroscopic identification (NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing desiccated at 2-8°C.

Specification

Item	Specification
Appearance	Off-white to light 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%
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.