Description

Apixaban Impurity 16 is a designated impurity standard used in the pharmaceutical development and quality control of the anticoagulant drug Apixaban. This high-purity reference material is critical for ensuring drug safety and efficacy by enabling accurate identification, quantification, and monitoring of this specific impurity during manufacturing. It is an essential tool for analytical laboratories, quality assurance departments, and research scientists in the pharmaceutical and fine chemical industries focused on API development and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Apixaban Impurity 16 in active pharmaceutical ingredient (API) batches.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling of Apixaban.
• Quality Control & Assurance (QC/QA): Used in routine quality control testing to ensure Apixaban API meets stringent pharmacopeial (e.g., USP, EP) and ICH guidelines for impurity limits.
• Stability Studies: Employed to monitor the formation and levels of this impurity during forced degradation and long-term stability studies of Apixaban drug substance and product.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and justify specifications.
• Research & Development: Supports synthetic route optimization and process chemistry research to understand and minimize the formation of this impurity.

Basic Information

Product Name	Apixaban Impurity 16
CAS No.	1619934-76-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	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; Apixaban Related Compound 16; Apixaban EP Impurity J; Apixaban USP Impurity 16; Apixaban Process 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

Every batch of Apixaban Impurity 16 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, LC-MS, NMR, and IR to ensure compliance with industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as specified on the certificate of analysis. Keep the container in a dry, cool, and well-ventilated area.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
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.