Description

Apixaban Impurity 27 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient Apixaban. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in method development, stability studies, and impurity profiling.

Application

• Pharmaceutical Reference Standard for the identification and quantification of impurities in Apixaban API.
• Analytical Method Development and Validation in quality control (QC) and research and development (R&D) laboratories.
• Stability Studies to monitor impurity formation in Apixaban drug products under various storage conditions.
• Regulatory Compliance and Documentation for drug master files (DMFs) and submissions to agencies like the FDA and EMA.
• Pharmacopoeial Testing to meet the specifications outlined in monographs such as USP or EP.
• Research on Degradation Pathways to understand the chemical behavior of Apixaban.

Basic Information

Product Name	Apixaban Impurity 27
CAS No.	2029205-54-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Apixaban Related Compound 27; Apixaban Impurity K; 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-7Q4K1R4N5P; 7Q4K1R4N5P; Apixaban Process Impurity
EINECS	Contact for details

Quality Control

Our products undergo rigorous quality testing to ensure compliance with industry standards. Each batch of Apixaban Impurity 27 is characterized using advanced analytical techniques to confirm identity and purity, aligning with the stringent requirements for pharmaceutical reference materials. Certificates of Analysis (COA) containing detailed chromatographic and spectroscopic data are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption.

Specification

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

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