Description

Apixaban Impurity 24 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 process-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 analytical method development and validation.
• Impurity Profiling: Identification and quantification of this specific impurity in Apixaban Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Stability Studies: Monitoring the formation and levels of this impurity during forced degradation and long-term stability testing of Apixaban.
• Regulatory Compliance & Filing: Providing necessary data for regulatory submissions (e.g., to FDA, EMA) to establish impurity thresholds and control strategies.
• Quality Control (QC) Testing: Routine use in in-process control and release testing of Apixaban batches to ensure they meet stringent pharmacopeial specifications.
• Process Chemistry Research: Used to study and optimize the Apixaban synthesis pathway to minimize the formation of this impurity.

Basic Information

Product Name	Apixaban Impurity 24
CAS No.	1928718-22-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Apixaban Related Compound 24; Apixaban Process Impurity 24; 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-7V4A8U16J8; 7V4A8U16J8
EINECS	Contact for details

Quality Control

Every batch of Apixaban Impurity 24 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC and MS to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This material is light-sensitive (store away from light) and hygroscopic (moisture-sensitive). For long-term storage, consider desiccant and inert atmosphere to ensure stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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