Description

Pazopanib Related Compound 3 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient, pazopanib hydrochloride, through precise impurity profiling and method validation. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in drug development and regulatory compliance. The product is supplied with comprehensive analytical data to support your quality control protocols.

Application

• Pharmaceutical Impurity Reference Standard: Used as a certified reference material for the identification and quantification of specific impurities in pazopanib hydrochloride API and finished drug products.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, UPLC, or LC-MS methods for stability-indicating assays.
• Quality Control & Assurance: Employed in routine QC testing to monitor impurity levels and ensure batch-to-batch consistency in pharmaceutical manufacturing under GMP guidelines.
• Regulatory Compliance & Filing: Provides necessary data for regulatory submissions (e.g., to FDA, EMA) to establish impurity acceptance criteria as per ICH Q3A/B guidelines.
• Stability Studies: Used to track the formation of degradation products in pazopanib formulations under various stress conditions.
• Research & Development: Facilitates chemical and pharmacological research into the metabolism and degradation pathways of pazopanib.

Basic Information

Product Name	Pazopanib Related Compound 3
CAS No.	1252927-44-8
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 Impurity 3; Pazopanib Related Substance 3; Pazopanib EP Impurity C; Pazopanib Hydrochloride Related Compound C; UNII-6K5P8U8B4P; GSK-3 Related Compound
EINECS	Contact for details

Quality Control

Every batch of Pazopanib Related Compound 3 is manufactured and controlled under a strict quality management system. The product undergoes comprehensive analytical testing, including chromatographic purity (HPLC), identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) is provided with each shipment, containing batch-specific results. Our quality commitment aligns with relevant pharmacopeial expectations and ICH 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 material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccant conditions.

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 unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Meets ICH Q3C guidelines

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