Description

Apixaban Impurity Ttq is a designated impurity reference standard used in the pharmaceutical development and quality control of the anticoagulant drug Apixaban. This high-purity compound is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification of process-related impurities. It is an essential material for analytical chemists and quality assurance professionals in pharmaceutical R&D, manufacturing, and regulatory affairs.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for method development, validation, and routine quality control testing of Apixaban active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development: Used to establish and optimize chromatographic methods (e.g., HPLC, UPLC) for the specific separation and detection of this impurity.
• Impurity Profiling and Identification: Serves as a critical tool for identifying unknown peaks in Apixaban batches, supporting investigations into manufacturing processes and stability studies.
• Stability Indicating Method: Employed in forced degradation studies to monitor the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submission Support: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity control and establish appropriate specification limits.
• Pharmacopoeial Testing: Supports testing in compliance with pharmacopoeial monographs (e.g., USP, EP) that specify control of related substances in Apixaban.

Basic Information

Product Name	Apixaban Impurity Ttq
CAS No.	2413365-22-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Apixaban Related Compound Ttq; Apixaban Process Impurity Ttq; Apixaban Specified Impurity Ttq; 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 (proposed); UNII-XXXX; Apixaban Impurity 12 (may vary by source); API-XABAN IMP TTQ
EINECS	Contact for details

Quality Control

Every batch of Apixaban Impurity Ttq is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced analytical techniques such as HPLC, GC, MS, and NMR to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available upon request.

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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