Description

Apixaban Impurity 44 is a designated process-related impurity used in the analytical profiling and quality control of the active pharmaceutical ingredient Apixaban. This high-purity reference standard is critical for pharmaceutical manufacturers and analytical laboratories to ensure product safety, efficacy, and regulatory compliance. It is primarily utilized in research and development, method validation, and stability studies for the anticoagulant drug Apixaban.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the qualitative and quantitative analysis of Apixaban API and finished drug products.
• Method Development & Validation (HPLC/LC-MS): Essential for developing, optimizing, and validating chromatographic methods to accurately identify and quantify this specific impurity.
• Stability Indicating Method: Used in forced degradation and long-term stability studies to monitor the formation of Apixaban Impurity 44 under various stress conditions.
• Quality Control & Batch Release: A critical component in the QC testing protocol to ensure Apixaban batches meet stringent purity specifications as per ICH guidelines.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., FDA, EMA) to support drug approval and market authorization.
• Process Chemistry Research: Aids in understanding and controlling the formation of this impurity during the synthesis and purification stages of Apixaban manufacturing.

Basic Information

Item	Details
Product Name	Apixaban Impurity 44
CAS No.	2206825-81-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Apixaban Related Compound 44; Apixaban EP Impurity J; Apixaban Process 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-7V2F8K5A0F; Apixaban Impurity J (EP); Apixaban Specified Impurity
EINECS	Contact for details

Quality Control

Our Apixaban Impurity 44 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis and spectroscopic characterization (NMR, MS), to ensure identity, potency, and traceability. A comprehensive Certificate of Analysis (COA) is supplied with every shipment, detailing batch-specific results. Our quality commitment aligns with cGMP principles and relevant pharmacopeial standards (USP, EP) for pharmaceutical reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the certificate of analysis. The material is hygroscopic (moisture-sensitive); keep the container tightly sealed in a dry environment.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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