Description

Pazopanib Impurity 9 is a designated impurity of the active pharmaceutical ingredient Pazopanib, a tyrosine kinase inhibitor used in targeted cancer therapy. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control processes. It is essential for manufacturers and analytical laboratories in the pharmaceutical industry who require high-purity chemical standards to ensure the safety, efficacy, and regulatory compliance of their drug products.

Application

• Primary use as a certified reference standard (CRS) for the quantitative and qualitative analysis of Pazopanib drug substance and drug products.
• Critical component in analytical method development and validation (HPLC, UPLC, LC-MS) for impurity profiling.
• Used in stability studies and forced degradation studies to understand the degradation pathways of Pazopanib.
• Essential for quality control (QC) and quality assurance (QA) laboratories to monitor impurity levels against ICH guidelines.
• Serves as a starting material or intermediate in the research and synthesis of related pharmaceutical compounds.
• Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files.

Basic Information

Product Name	Pazopanib Impurity 9
CAS No.	1296888-47-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Pazopanib Related Compound 9; Pazopanib EP Impurity I; Pazopanib USP Impurity; Pazopanib Process Impurity; 5-[[4-[(2,3-Dimethyl-2H-indazol-6-yl)methylamino]pyrimidin-2-yl]amino]-2-methylbenzenesulfonamide (related impurity); Votrient Impurity 9; GW786034 Impurity 9
EINECS	Contact for details

Quality Control

Our Pazopanib Impurity 9 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and identity verification by spectroscopic methods (IR, NMR, MS). We provide comprehensive Certificates of Analysis (COA) with detailed chromatographic data, ensuring traceability and compliance with current pharmacopeial standards (USP, EP) and ICH guidelines. Our quality commitment supports your regulatory and research requirements with reliable and consistent reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The material is typically hygroscopic (moisture-sensitive); keep the container tightly sealed in a dry environment. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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