Description

Pazopanib Impurity 2 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient 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 2 in Pazopanib API and finished dosage forms.
• Method Development and Validation: Essential for developing, optimizing, and validating stability-indicating HPLC/UPLC methods in quality control laboratories.
• Stability Studies: Employed to monitor the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Regulatory Compliance and Filing: Critical for preparing regulatory submission documents (e.g., for FDA, EMA) to establish impurity profiles and justify specification limits.
• Quality Control Testing: Routinely used in in-process control and release testing of Pazopanib batches to ensure compliance with established pharmacopeial or in-house specifications.
• Research and Development: Supports synthetic route optimization and impurity fate and tolerance studies during the drug development process.

Basic Information

Item	Details
Product Name	Pazopanib Impurity 2
CAS No.	1821666-73-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Pazopanib Related Compound 2; Pazopanib Impurity B; Pazopanib EP Impurity B; Pazopanib USP Impurity; 5-[[4-[(2,3-Dimethyl-2H-indazol-6-yl)methylamino]pyrimidin-2-yl]amino]-2-methylbenzenesulfonamide impurity; Votrient Impurity 2; GW786034 Impurity 2
EINECS	Contact for details

Quality Control

Every batch of Pazopanib Impurity 2 is manufactured and analyzed under strict quality management systems. The product undergoes comprehensive testing, including identification by spectroscopic methods (IR, NMR, MS), purity assessment by HPLC, and control of related substances and residual solvents. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with specified standards. Our quality commitment aligns with cGMP principles to support our clients' regulatory needs.

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 material is hygroscopic (moisture-sensitive) and must be kept under dry, inert conditions to maintain stability and purity. The container should be sealed tightly after each use to minimize exposure to atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
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.