Description

Apixaban Impurity 72 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of the anticoagulant drug Apixaban. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification of related substances. It is an essential material for analytical chemists and quality assurance professionals in pharmaceutical R&D and manufacturing.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material for the identification and quantification of Apixaban Impurity 72 in drug substance and drug product batches.
• Method Development and Validation: Used to develop, optimize, and validate analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and Liquid Chromatography-Mass Spectrometry (LC-MS) methods.
• Stability Studies: Employed to monitor the formation of this specific impurity during forced degradation and long-term stability testing of Apixaban.
• Quality Control & Release Testing: A critical component in the routine quality control testing of Apixaban Active Pharmaceutical Ingredient (API) to ensure it meets stringent pharmacopeial specifications (e.g., ICH Q3A/B).
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to establish impurity profiles and justify specification limits.
• Process Chemistry Research: Used by chemists to study and optimize the Apixaban synthesis pathway, helping to minimize the formation of this impurity.

Basic Information

Product Name	Apixaban Impurity 72
CAS No.	1998079-12-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Apixaban Related Compound 72; Apixaban EP Impurity G; Apixaban USP Impurity; 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 72; BMS-562247-01 Impurity
EINECS	Contact for details

Quality Control

Every batch of Apixaban Impurity 72 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC and LC-MS to ensure compliance with pharmacopeial standards and customer specifications. 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 at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, cool, and well-ventilated area. Handle and store in accordance with good laboratory practices.

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)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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