Description

Apixaban Dehydro Impurity is a key 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 primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions focused on cardiovascular therapeutics and API impurity profiling.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the analytical method development and validation of Apixaban API and finished dosage forms.
• Quality Control & Assurance: Used in routine HPLC/LC-MS testing to monitor and control the levels of this specific degradation product during API synthesis and drug product stability studies.
• Regulatory Compliance & Filing: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity identification and characterization reports.
• Process Chemistry Research: Employed in studying the degradation pathways and stability profile of Apixaban to optimize manufacturing and formulation processes.
• Analytical Laboratory Calibration: Acts as a primary standard for calibrating instruments and ensuring the accuracy of impurity assays in quality control laboratories.

Basic Information

Product Name	Apixaban Dehydro Impurity
CAS No.	1074549-89-5
Molecular Formula	C25H25N5O4
Molecular Weight	459.50 g/mol
Synonyms	Apixaban Dehydro Impurity; Apixaban Impurity D; Dehydro Apixaban; 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; 1,5-Dihydro-1-(4-methoxyphenyl)-7-oxo-6-[4-(2-oxo-1-piperidinyl)phenyl]-4H-pyrazolo[3,4-c]pyridine-3-carboxamide; UNII-8JQ5607E5S; Apixaban Related Compound D
EINECS	Contact for details

Quality Control

Our Apixaban Dehydro Impurity is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high-purity standards required for pharmaceutical reference materials. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile, supporting compliance with ICH Q3A/B guidelines and cGMP principles.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
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.