Description

Sunitinib Impurity 23 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient Sunitinib Malate. This high-purity reference material is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and routine batch testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Sunitinib Impurity 23 in Sunitinib Malate drug substance and drug product.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing and validating stability-indicating chromatographic methods to monitor impurity profiles.
• Quality Control & Batch Release Testing: A critical component in the quality control workflow to ensure drug substance and product meet stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines.
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress conditions (thermal, photolytic, hydrolytic) as part of forced degradation and shelf-life studies.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to establish impurity limits and justify the control strategy for the drug substance.
• Research & Development: Supports process chemistry research to understand impurity formation pathways and optimize synthesis and purification processes.

Basic Information

Product Name	Sunitinib Impurity 23
CAS No.	1309935-09-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Sunitinib Related Compound 23; Sunitinib Malate Impurity 23; Sunitinib EP Impurity C; 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; 5-[(Z)-(5-Fluoro-2-oxo-1H-indol-3-ylidene)methyl]-2,4-dimethyl-N-(2-diethylaminoethyl)-1H-pyrrole-3-carboxamide; Sunitinib Isomer Impurity
EINECS	Contact for details

Quality Control

Our Sunitinib Impurity 23 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and traceability. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from advanced techniques like HPLC, LC-MS, and NMR. We support compliance with ICH Q3A, Q3B, USP, and EP guidelines, and our quality commitment ensures material suitable for regulatory submission and GMP manufacturing environments.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the certificate of analysis. The material is hygroscopic (moisture-sensitive) and should be handled under dry conditions to maintain stability.

Specification

Item	Specification
Appearance	Off-white to yellow solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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