Description

Sunitinib Impurity 14 is a designated impurity of the active pharmaceutical ingredient Sunitinib, a multi-targeted receptor tyrosine kinase inhibitor. This high-purity reference standard is critical for pharmaceutical research and development, specifically for method development, validation, and quality control of Sunitinib drug substances and products. It is an essential material for analytical chemists and quality assurance professionals in the pharmaceutical and contract research organization (CRO) sectors who require reliable, well-characterized impurities 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 Sunitinib Impurity 14 in Sunitinib active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing and validating stability-indicating HPLC or UPLC methods to monitor impurity profiles throughout the drug product lifecycle.
• Quality Control & Batch Release: Used in routine QC testing to ensure Sunitinib batches meet stringent pharmacopeial (e.g., USP, EP) and internal specification limits for related substances.
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress conditions (heat, light, humidity) as part of forced degradation and long-term stability programs.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and justify specifications in accordance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Process Chemistry Research: Aids in understanding the formation pathway of this impurity during Sunitinib synthesis, enabling process optimization and impurity control strategies.

Basic Information

Product Name	Sunitinib Impurity 14
CAS No.	1309935-08-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Sunitinib Related Compound 14; Sunitinib Impurity; Sunitinib EP Impurity; Sunitinib USP Impurity; Sunitinib Process Impurity; (Z)-N-[2-(Diethylamino)ethyl]-5-[(5-fluoro-2-oxo-1H-indol-3-ylidene)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide (related to); SU11248 Impurity 14
EINECS	Contact for details

Quality Control

Our Sunitinib Impurity 14 is manufactured under controlled conditions and undergoes rigorous analytical characterization to ensure identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from advanced techniques such as HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We adhere to high-quality standards suitable for pharmaceutical R&D and can provide support for qualification as a reference standard.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C) or as indicated on the label. This compound is hygroscopic (moisture-sensitive) and should be handled under dry conditions 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)	Consistent with molecular structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 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.