Description

Apixaban Impurity 46 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: Primary use as a certified reference material for the identification and quantification of Apixaban Impurity 46 in drug substance and drug product.
• Analytical Method Development & Validation: Used to develop, optimize, and validate HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Batch Release Testing: A critical component in the routine quality control testing of Apixaban active pharmaceutical ingredient (API) to ensure it meets pharmacopeial and ICH guidelines.
• Stability Studies: Employed to monitor impurity levels in Apixaban formulations under various stress and long-term storage conditions.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity limits and control strategies.
• Process Chemistry Research: Used to study and control the formation of this impurity during the synthesis and purification of Apixaban.

Basic Information

Product Name	Apixaban Impurity 46
CAS No.	2219376-48-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Apixaban Related Compound 46; Apixaban EP Impurity J; Apixaban USP Impurity 46; 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-Contact for details; Apixaban Process Impurity; Apixaban Degradant
EINECS	Contact for details

Quality Control

Our Apixaban Impurity 46 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis, identity confirmation (IR, MS), and residual solvent screening, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

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. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
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.