Description

Alogliptin Impurity 45 is a designated pharmaceutical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the antidiabetic drug Alogliptin. It is primarily required by pharmaceutical manufacturers and analytical laboratories for method development, validation, and impurity profiling studies. The compound is supplied with comprehensive analytical data to support stringent quality control protocols.

Application

• Pharmaceutical Reference Standard for the identification and quantification of impurities in Alogliptin API and finished dosage forms.
• Method Development and Validation in analytical laboratories for HPLC, UPLC, and LC-MS techniques.
• Quality Control & Assurance (QC/QA) to monitor and control impurity levels during drug substance and drug product manufacturing.
• Regulatory Compliance and Filing, providing essential data for regulatory submissions (e.g., FDA, EMA) as per ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies to track impurity formation under various stress conditions.
• Research and Development (R&D) for studying the degradation pathways and chemistry of Alogliptin.

Basic Information

Product Name	Alogliptin Impurity 45
CAS No.	1473368-47-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Alogliptin Related Compound 45; Benzoic acid, 2-[[6-[(3R)-3-aminopiperidin-1-yl]-3,4-dihydro-3-methyl-2,4-dioxo-1(2H)-pyrimidinyl]methyl]-4-fluoro-; (R)-2-((6-(3-Aminopiperidin-1-yl)-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)methyl)-4-fluorobenzoic acid; Alogliptin EP Impurity F; Alogliptin USP Impurity; Alogliptin Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Alogliptin Impurity 45 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assessment, and impurity profiling using advanced chromatographic and spectroscopic techniques (HPLC, LC-MS, NMR) to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

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 must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
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.