Description

Apixaban Impurity 45 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, a widely prescribed anticoagulant. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and research institutions for method development, validation, and routine quality control testing.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material to identify and quantify related substances in Apixaban API and finished drug products.
• Analytical Method Development and Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods to monitor process-related impurities.
• Stability Studies and Forced Degradation Testing: Employed to understand the degradation pathways of Apixaban and to establish appropriate shelf-life specifications.
• Quality Control and Batch Release Testing: Essential for routine QC testing to ensure Apixaban batches meet stringent pharmacopeial (e.g., USP, EP) and ICH guidelines for impurity limits.
• Regulatory Submissions and Compliance: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity characterization and control.
• Research and Development: Used in R&D to study the synthesis, metabolism, and pharmacokinetics of Apixaban and its related compounds.

Basic Information

Product Name	Apixaban Impurity 45
CAS No.	1904628-10-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Apixaban Related Compound 45; Apixaban EP Impurity J; 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 45; BMS-562247-01 Impurity; 1H-Pyrazolo[3,4-c]pyridine-3-carboxamide, 4,5,6,7-tetrahydro-1-(4-methoxyphenyl)-7-oxo-6-[4-(2-oxo-1-piperidinyl)phenyl]-
EINECS	Contact for details

Quality Control

Our Apixaban Impurity 45 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the highest standards for pharmaceutical reference materials. Each batch is characterized using advanced techniques including HPLC, LC-MS, and NMR to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is provided, detailing batch-specific results and confirming compliance with relevant standards. We support compliance with ICH Q3A/B, USP, and EP guidelines.

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 product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere conditions.

Specification

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

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