Description

Apixaban Amino Acid Impurity is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality and safety of the active pharmaceutical ingredient (API) Apixaban by identifying and quantifying related process impurities. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing. The precise characterization of such impurities is essential for meeting stringent pharmacopeial standards and regulatory compliance in drug development.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material for the identification and quantification of specific amino acid-related impurities in Apixaban API batches.
• Analytical Method Development: Used in HPLC, UPLC, and LC-MS methods to establish retention times, calibration curves, and detection limits for impurity profiling.
• Quality Control & Assurance: Employed in routine QC testing of Apixaban drug substance and finished drug products to ensure compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Provides essential data for impurity identification reports required by regulatory agencies like the FDA and EMA during drug approval processes.
• Stability Studies: Used to monitor the formation of degradation products in Apixaban formulations under various stress conditions.
• Research & Development: Facilitates process chemistry research to understand and minimize the formation of this impurity during Apixaban synthesis.

Basic Information

Product Name	Apixaban Amino Acid Impurity
CAS No.	2206825-87-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Apixaban Related Compound; Apixaban Process Impurity; Apixaban Amino Acid Derivative; 5-Chloro-N-((2S,3R)-1-((2S)-2-(4-(morpholin-4-yl)phenylamino)-2-oxo-1-phenylethyl)-4-oxo-2-phenylazetidin-3-yl)thiophene-2-carboxamide (related isomer); Apixaban Impurity AA; Apixaban Synthetic Impurity; Amino Acid Impurity of Apixaban
EINECS	Contact for details

Quality Control

Our Apixaban Amino Acid Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis and spectroscopic confirmation (NMR, MS), to ensure identity, potency, and consistency. Certificates of Analysis (COA) detailing batch-specific results are provided and traceable to primary reference standards. Our quality commitment aligns with ICH guidelines and supports compliance in regulated pharmaceutical environments.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. Avoid repeated or prolonged exposure to the atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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