Description

Apixaban Impurity 52 is a high-purity chemical reference standard used in the analytical profiling of the anticoagulant active pharmaceutical ingredient (API) Apixaban. This compound is critical for pharmaceutical quality control and regulatory compliance, serving as a known impurity for method development and validation. It is primarily utilized by research scientists, analytical chemists, and quality assurance professionals in pharmaceutical development and manufacturing to ensure product safety and efficacy.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the quantitative and qualitative analysis of Apixaban.
• Method Development and Validation: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurities in Apixaban API and finished drug products.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to ensure Apixaban meets stringent pharmacopeial (e.g., USP, EP) impurity limits.
• Stability Studies: Used to identify and quantify degradation products that may form under various stress conditions.
• Regulatory Submissions: Supports the filing of regulatory documents (e.g., CMC sections for FDA, EMA) by providing impurity characterization data.
• Process Chemistry Research: Aids in optimizing API synthesis and purification processes by tracking specific impurity formation.

Basic Information

Product Name	Apixaban Impurity 52
CAS No.	1620494-31-6
Molecular Formula	C25H25N5O4
Molecular Weight	459.50 g/mol
Synonyms	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; Apixaban Related Compound 52; Apixaban Impurity K; Apixaban EP Impurity K; Apixaban Process Impurity; Apixaban Degradant
EINECS	Contact for details

Quality Control

Every batch of Apixaban Impurity 52 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, LC-MS, and NMR to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
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.