Description

Apixaban Impurity 17 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) Apixaban by serving as a well-characterized impurity marker. It is primarily required by pharmaceutical manufacturers, quality control (QC) laboratories, and research institutions engaged in the development, validation, and routine monitoring of Apixaban production processes.

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: Essential for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) for impurity detection.
• Quality Control and Release Testing: Serves as a system suitability and calibration standard in routine QC testing to ensure batch-to-batch consistency and compliance with regulatory specifications (ICH Q3A/B).
• Stability Studies: Employed to monitor the formation of degradation products in Apixaban under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity limits and justify the control strategy.
• Research and Development: Used in pharmacokinetic and metabolic studies to understand the degradation pathways of Apixaban.

Basic Information

Product Name	Apixaban Impurity 17
CAS No.	2204368-51-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Apixaban Related Compound 17; Apixaban 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; UNII-0J3V7S6A5T; 0J3V7S6A5T; 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 17 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment to support your regulatory and quality assurance needs.

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 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 (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
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.