Description

Pazopanib Impurity 25 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Pazopanib hydrochloride. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a reference marker in chromatographic methods. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development, production, 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 25 in Pazopanib API and finished drug products.
• Method Development and Validation: Essential for developing, optimizing, and validating stability-indicating HPLC or UPLC methods in quality control laboratories.
• Stability Studies: Employed to monitor the formation of this specific impurity during forced degradation and long-term stability studies of Pazopanib.
• Regulatory Compliance and Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Quality Control Testing: Serves as a system suitability standard and for routine batch release testing to ensure impurity levels are within International Council for Harmonisation (ICH) guidelines.
• Research and Development: Utilized in synthetic chemistry research to understand degradation pathways and to develop purification processes for the Pazopanib API.

Basic Information

Product Name	Pazopanib Impurity 25
CAS No.	90007-09-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Pazopanib Related Compound 25; Pazopanib Impurity; Pazopanib EP Impurity; Pazopanib USP Impurity; Votrient Impurity 25; GW786034 Impurity 25; 5-[[4-[(2,3-Dimethyl-2H-indazol-6-yl)methylamino]pyrimidin-2-yl]amino]-2-methylbenzenesulfonamide Impurity
EINECS	Contact for details

Quality Control

Our Pazopanib Impurity 25 is manufactured and controlled under a strict quality management system. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS), 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, supporting compliance with ICH Q3A/B, USP, and EP guidelines.

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 (HPLC)	Retention time matches reference standard
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified 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.