Description

Apixaban Impurity 18 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 (API) Apixaban, a widely prescribed anticoagulant. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and routine quality control testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Apixaban API and finished dosage forms.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurities during the drug manufacturing process.
• Quality Control & Assurance (QC/QA): Serves as a system suitability and calibration standard in routine QC testing to ensure batch-to-batch consistency and compliance with pharmacopeial limits (e.g., ICH Q3A/B).
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity characterization data for drug master files (DMFs) and new drug applications (NDAs).
• Stability Studies: Employed to track the formation of this specific impurity under various stress conditions (heat, light, humidity) to establish product shelf-life.
• Research & Development: Used in academic and industrial R&D to study the degradation pathways, metabolism, and synthesis of Apixaban and its analogs.

Basic Information

Product Name	Apixaban Impurity 18
CAS No.	473927-65-0
Molecular Formula	C25H25N5O4
Molecular Weight	459.50 g/mol
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 18; Apixaban Impurity K; Apixaban EP Impurity K; Apixaban USP Impurity 18; BMS-562247-18; UNII-9S7K9F8V4S
EINECS	Contact for details

Quality Control

Every batch of Apixaban Impurity 18 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (HPLC, LC-MS, NMR) to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is hygroscopic (moisture-sensitive); the container must be kept tightly sealed and stored in a desiccator to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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