Description

Apixaban Impurity 42 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for the quality control and regulatory compliance of Apixaban, a widely prescribed anticoagulant medication. It is primarily utilized by analytical laboratories, quality assurance departments, and research scientists within the pharmaceutical and biotechnology industries to ensure drug purity and safety.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Apixaban Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Batch Release Testing: Essential for routine quality control testing to monitor impurity levels and ensure batches meet pharmacopeial (e.g., USP, EP) and internal specifications.
• Stability Studies: Employed in forced degradation and long-term stability studies of Apixaban to understand degradation pathways and establish shelf-life.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research on Degradation Pathways: Aids in research to elucidate the formation mechanisms of this specific impurity during synthesis or storage.

Basic Information

Product Name	Apixaban Impurity 42
CAS No.	132577-23-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Apixaban Related Compound 42; Apixaban Impurity K; Apixaban EP Impurity K; 1-(4-Methoxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-1-yl)phenyl]-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxamide; Eliquis Impurity 42; BMS-562247-42 Impurity
EINECS	Contact for details

Quality Control

Every batch of Apixaban Impurity 42 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results, including HPLC purity, is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. Handle the material with appropriate care to prevent contamination.

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 guidelines

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