Description

Pazopanib Impurity 3 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient Pazopanib. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a reference marker in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development and quality assurance of Pazopanib-based oncology treatments.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Pazopanib Impurity 3 in Pazopanib API and finished dosage forms.
• Method Development and Validation: Essential for developing, optimizing, and validating analytical methods, particularly HPLC and UPLC, in compliance with ICH guidelines.
• Quality Control (QC) Testing: A critical component in routine QC release testing and stability studies to monitor impurity levels and ensure batch-to-batch consistency.
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity characterization and qualification data.
• Research and Development: Used in pharmaceutical R&D to study the degradation pathways and stability profile of Pazopanib.
• Pharmacopoeial Testing: Applicable for testing against monograph specifications in pharmacopoeias such as USP or EP where relevant.

Basic Information

Product Name	Pazopanib Impurity 3
CAS No.	444731-47-9
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 C; Pazopanib Impurity C; Pazopanib EP Impurity C; GW786034 Impurity 3; UNII-9H4LJ5V2Q5
EINECS	Contact for details

Quality Control

Our Pazopanib Impurity 3 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC purity, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets high-purity standards suitable for use as a reference material. 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 in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unspecified impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
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.