Description

Pazopanib Impurity 32 is a designated impurity of Pazopanib, a targeted anticancer medication. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control of the active pharmaceutical ingredient (API). It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Pazopanib drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Pazopanib Impurity 32 in drug substance and drug product batches.
• Analytical Method Development: Essential for developing and optimizing chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance: Critical for routine quality control testing to monitor impurity levels and ensure compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing impurity characterization data.
• Stability Studies: Employed to track the formation of this specific impurity under various stress conditions during drug stability testing.
• Process Chemistry Research: Used to study and control the formation of this impurity during the synthesis and purification of Pazopanib API.

Basic Information

Product Name	Pazopanib Impurity 32
CAS No.	1072836-76-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Pazopanib Related Compound 32; Pazopanib Impurity; Pazopanib EP Impurity; Pazopanib USP Impurity; Pazopanib Process Impurity; Pazopanib Degradant; 5-[[4-[(2,3-Dimethyl-2H-indazol-6-yl)methylamino]pyrimidin-2-yl]amino]-2-methylbenzenesulfonamide Impurity; GW786034 Impurity 32
EINECS	Contact for details

Quality Control

Our Pazopanib Impurity 32 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis, identity confirmation (IR, MS), and residual solvent screening, 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. The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single 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.