Description

Alogliptin Related Compound 26 is a high-purity chemical reference standard used in the pharmaceutical development and quality control processes. This compound is critical for ensuring the accuracy and reliability of analytical methods, particularly in the identification and quantification of impurities in Alogliptin API and finished drug products. It serves as an essential tool for research scientists and quality assurance professionals in the pharmaceutical and biotechnology industries who require definitive standards for method validation and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of specific impurities or degradation products in Alogliptin drug substances and products.
• Analytical Method Development & Validation: Critical component in developing and validating High-Performance Liquid Chromatography (HPLC), Ultra-Performance Liquid Chromatography (UPLC), and mass spectrometry methods.
• Quality Control (QC) Testing: Used in routine QC laboratories to monitor batch-to-batch consistency and ensure impurity profiles meet stringent pharmacopeial standards (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Employed to track the formation of related substances during forced degradation and long-term stability studies of Alogliptin formulations.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research & Development: Supports synthetic chemistry research for process optimization and impurity profiling during the development of Alogliptin and related dipeptidyl peptidase-4 (DPP-4) inhibitors.

Basic Information

Product Name	Alogliptin Related Compound 26
CAS No.	865759-10-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Alogliptin Impurity 26; Alogliptin Related Substance 26; Alogliptin Specified Impurity 26; SYR-322 Related Compound 26; (2R)-3-hydroxy-1-(2,4,5-trifluorophenyl)propan-2-aminium; 2,4,5-Trifluoro-N-[(2R)-3-hydroxy-2-aminopropyl]benzenaminium; DPP-4 Inhibitor Related Compound
EINECS	Contact for details

Quality Control

Every batch of Alogliptin Related Compound 26 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques to ensure compliance with industry standards for reference materials. A comprehensive Certificate of Analysis (COA), detailing results for purity (HPLC), related substances, and identification tests, is provided with each shipment and is available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. For long-term stability, consider storage at 2-8°C. Keep the container tightly sealed to protect from moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Assay (HPLC)	90.0% - 110.0% on anhydrous basis
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.