Description

Apixaban Impurity 73 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 chemists and quality assurance professionals in the pharmaceutical industry for method development, validation, and impurity profiling studies to ensure drug safety and efficacy.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for identifying and quantifying process-related impurities in Apixaban active pharmaceutical ingredient (API) batches.
• Analytical Method Development & Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods, such as HPLC and UPLC, for impurity detection.
• Quality Control & Assurance (QC/QA): Essential for routine quality control testing in API and finished drug product manufacturing to meet ICH guidelines and regulatory specifications.
• Stability Studies: Employed as a marker compound in forced degradation and long-term stability studies of Apixaban to monitor impurity formation over time.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to establish impurity limits and ensure compliance with pharmacopeial standards.
• Research & Development: Used in synthetic chemistry research to understand degradation pathways and to synthesize purer batches of the API.

Basic Information

Product Name	Apixaban Impurity 73
CAS No.	1998079-13-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
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 73; Eliquis Impurity 73; BMS-562247-01 Impurity; UNII-9V8V3Q8F4T component
EINECS	Contact for details

Quality Control

Our Apixaban Impurity 73 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing identity, purity, and impurity profiles is provided with every shipment to support your regulatory and research needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

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.