Description

Pazopanib Impurity 8 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Pazopanib, a tyrosine kinase inhibitor. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions for method development, validation, and routine quality control testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Pazopanib Impurity 8 in Pazopanib API and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing and validating chromatographic methods to monitor and control impurity profiles during API synthesis and formulation.
• Quality Control & Assurance (QC/QA): Serves as a critical tool for in-process testing, release testing, and stability studies to ensure product purity meets pharmacopeial standards (e.g., USP, EP, ICH).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., FDA, EMA) by providing necessary data on impurity characterization, qualification, and control strategies.
• Research & Development: Utilized in metabolic studies, degradation pathway elucidation, and stability-indicating method research for Pazopanib.
• Contract Research Organizations (CROs): Employed by CROs providing analytical and bioanalytical services to the pharmaceutical industry.

Basic Information

Product Name	Pazopanib Impurity 8
CAS No.	1226500-00-0
Molecular Formula	C21H23N7O2S
Molecular Weight	437.52 g/mol
Synonyms	5-[[4-[(2,3-Dimethyl-2H-indazol-6-yl)methylamino]pyrimidin-2-yl]amino]-2-methylbenzenesulfonamide; Pazopanib Related Compound 8; Pazopanib Impurity C; Pazopanib EP Impurity C; Pazopanib USP Impurity; GW786034 Impurity 8; N-(4-Pyrimidin-2-ylaminophenyl)-N'-(2,3-dimethyl-2H-indazol-6-yl)urea sulfonamide derivative
EINECS	Contact for details

Quality Control

Our Pazopanib Impurity 8 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from HPLC, LC-MS, NMR, and IR analyses. The quality standards are aligned with ICH Q3A/B guidelines for impurities in new drug substances and products.

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 at 2-8°C. The material is hygroscopic (moisture-sensitive); ensure the container is sealed after each use to prevent absorption of moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.2%

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