Description

Ponatinib Impurity 10 is a designated impurity of the active pharmaceutical ingredient (API) Ponatinib, a tyrosine kinase inhibitor. This high-purity reference standard is critical for analytical method development, validation, and quality control processes in pharmaceutical manufacturing. It is primarily used by research institutions, quality control laboratories, and pharmaceutical companies involved in the development and production of Ponatinib to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material for the identification and quantification of impurities in Ponatinib API and finished drug products.
• Analytical Method Development: Used to develop and optimize chromatographic methods (e.g., HPLC, UPLC) for impurity profiling.
• Quality Control & Assurance: Essential for routine batch testing to monitor impurity levels against International Council for Harmonisation (ICH) guidelines.
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing impurity characterization data.
• Stability Studies: Employed to track the formation of this specific impurity under various stress conditions to determine drug product shelf life.
• Research & Development: Used in studies to understand the degradation pathways and chemical behavior of Ponatinib.

Basic Information

Product Name	Ponatinib Impurity 10
CAS No.	122947-77-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ponatinib Related Compound 10; Ponatinib Impurity; AP24534 Impurity 10; 3-(2-Imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-N-[4-[(4-methylpiperazin-1-yl)methyl]-3-(trifluoromethyl)phenyl]benzamide Impurity; Iclusig Impurity 10
EINECS	Contact for details

Quality Control

Every batch of Ponatinib Impurity 10 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and consistency. Certificates of Analysis (COA) are provided, detailing comprehensive analytical results and confirming compliance with in-house specifications aligned with ICH Q3A/B guidelines. We support cGMP requirements for pharmaceutical reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. Keep the container sealed to protect the material from moisture.

Specification

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