Description

Apixaban Impurity 20 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Apixaban. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in method development, validation, and impurity profiling. The reliable identification and quantification of this impurity are fundamental to maintaining the highest standards in drug development and production.

Application

This high-purity impurity standard serves several key functions in the pharmaceutical and analytical chemistry sectors:

• Pharmaceutical Quality Control (QC): Used as a certified reference standard for the identification and quantification of Apixaban Impurity 20 in bulk drug substances and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) for impurity analysis.
• Stability Studies: Employed to monitor the formation and levels of this specific impurity during forced degradation and long-term stability testing of Apixaban.
• Regulatory Compliance & Documentation: Supports the preparation of regulatory submission dossiers (e.g., for FDA, EMA) by providing a characterized impurity profile.
• Research & Development: Used in synthetic chemistry research to study the formation pathways and chemical behavior of this impurity.
• Pharmacopoeial Testing: Can be utilized as a working standard for testing against pharmacopoeial monographs where this impurity is specified.

Basic Information

Product Name	Apixaban Impurity 20
CAS No.	1421823-20-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Apixaban Related Compound 20; Apixaban 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; UNII-9K7K5Y8F0I; 9K7K5Y8F0I; 1421823-20-2
EINECS	Contact for details

Quality Control

Every batch of Apixaban Impurity 20 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. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We are committed to meeting the stringent requirements of pharmaceutical reference standards, supporting compliance with cGMP, ICH Q3A/B, and relevant pharmacopoeial 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 must be kept under dry conditions to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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