Description

Apixaban Impurity Bms-724914 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, a widely prescribed anticoagulant. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing. The reliable identification and quantification of this impurity are essential for meeting stringent pharmacopeial standards and regulatory compliance in drug development and production.

Application

• Pharmaceutical Quality Control (QC): Used as a certified reference standard for the identification and quantification of specific impurities in Apixaban API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing data for impurity characterization and establishing specification limits.
• Stability Studies: Employed to track the formation and levels of this impurity during forced degradation and long-term stability studies of Apixaban.
• Research & Development (R&D): Serves as a key material in pharmaceutical R&D for studying the degradation pathways and synthesis process of Apixaban.
• Contract Research Organizations (CROs): Used by CROs providing analytical testing services to the pharmaceutical industry.

Basic Information

Product Name	Apixaban Impurity Bms-724914
CAS No.	2187409-01-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	BMS-724914; Apixaban Related Compound B; Apixaban Impurity B; Apixaban EP Impurity B; Apixaban USP Impurity B; 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 (IUPAC-based); Apixaban Process Impurity.
EINECS	Contact for details

Quality Control

Every batch of Apixaban Impurity Bms-724914 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including potential alignment with pharmacopeial guidelines (e.g., USP, EP). Comprehensive characterization is performed using advanced analytical techniques. Certificates of Analysis (COA) detailing purity, identity, and impurity profiles are available upon request 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 (typically 15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under dry conditions to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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