Description

Apixaban Impurity 24 is a designated impurity standard used in the pharmaceutical development and quality control of the anticoagulant drug Apixaban. This high-purity reference material is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the qualitative and quantitative analysis of Apixaban drug substance and drug products.
• Method Development and Validation (HPLC/LC-MS): Essential for developing, validating, and verifying analytical methods to detect and quantify this specific impurity.
• Stability Indicating Studies: Employed in forced degradation and long-term stability studies to monitor the formation of Apixaban Impurity 24 under various stress conditions.
• Quality Control and Batch Release: A critical component in the QC testing of Apixaban active pharmaceutical ingredient (API) to ensure it meets stringent purity specifications.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to establish impurity thresholds and control strategies.
• Research and Development: Used in R&D to understand the degradation pathways and synthesis by-products of Apixaban.

Basic Information

Product Name	Apixaban Impurity 24
CAS No.	2264018-89-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Apixaban Related Compound 24; Apixaban EP Impurity I; 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 24; BMS-562247-01 Impurity
EINECS	Contact for details

Quality Control

Our Apixaban Impurity 24 is manufactured under strict quality systems to ensure the highest standards of purity and traceability. Each batch is characterized and tested using advanced analytical techniques, including HPLC, LC-MS, and NMR, to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing all test results and specifications. Our quality commitment aligns with the requirements for pharmaceutical reference standards.

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. The material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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