Description

Pazopanib Impurity 22 is a designated impurity of the active pharmaceutical ingredient Pazopanib Hydrochloride, a tyrosine kinase inhibitor. 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 primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories involved in the synthesis, purification, and regulatory compliance of Pazopanib.

Application

• Primary use as a pharmaceutical reference standard for the identification and quantification of impurities in Pazopanib Hydrochloride drug substance and finished products.
• Essential for analytical method development and validation (HPLC, UPLC, LC-MS) to ensure specificity, accuracy, and precision.
• Critical component in stability studies and forced degradation studies to monitor impurity profiles over time and under stress conditions.
• Used in quality control (QC) and quality assurance (QA) laboratories to establish and monitor specification limits per ICH guidelines.
• Supports regulatory submissions (e.g., to FDA, EMA) by providing characterized impurity data for drug master files (DMFs) and marketing authorization applications.
• Valuable for process chemistry research to understand and optimize synthesis pathways to minimize impurity formation.

Basic Information

Product Name	Pazopanib Impurity 22
CAS No.	1226500-01-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Pazopanib Related Compound 22; Pazopanib Impurity C; Pazopanib EP Impurity C; Pazopanib Hydrochloride Impurity 22; 5-[[4-[(2,3-Dimethyl-2H-indazol-6-yl)methylamino]pyrimidin-2-yl]amino]-2-methylbenzenesulfonamide Impurity; UNII-Contact for details; Pazopanib Specified Impurity
EINECS	Contact for details

Quality Control

Our Pazopanib Impurity 22 is manufactured and handled under strict quality management systems. Each batch undergoes comprehensive analytical testing, including chromatographic purity (HPLC), identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) with batch-specific data is provided, supporting compliance with ICH Q3A, Q3B, and relevant pharmacopeial 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) or as indicated on the certificate of analysis. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

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

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