Description

Alogliptin Related Compound 14 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 detection and quantification of impurities in active pharmaceutical ingredients (APIs). It is primarily utilized by research scientists and quality assurance professionals in the pharmaceutical and biotechnology industries for method validation, stability studies, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Alogliptin and related drug substances.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods in quality control laboratories.
• Stability Indicating Studies: Employed in forced degradation and long-term stability studies to monitor the formation of degradation products in drug formulations.
• Regulatory Compliance and Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Quality Control Testing: Used in routine batch release testing of Alogliptin API to ensure product purity meets pharmacopeial standards (e.g., USP, EP).
• Research and Development: Supports synthetic chemistry research for process optimization and impurity synthesis pathway elucidation.

Basic Information

Product Name	Alogliptin Related Compound 14
CAS No.	1820685-30-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	2-({6-[(3R)-3-Aminopiperidin-1-yl]-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl}methyl)benzonitrile; Alogliptin Impurity; Alogliptin Related Substance 14; TAK-875 Related Compound; 1(2H)-Pyrimidineacetic acid, 6-[(3R)-3-amino-1-piperidinyl]-3-methyl-2,4-dioxo-, 2-cyanobenzyl ester; SYR-322 Impurity.
EINECS	Contact for details

Quality Control

Every batch of Alogliptin Related Compound 14 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for all critical quality attributes. We support compliance with ICH Q3A/B guidelines and other relevant pharmacopeial standards.

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. The original container should be kept sealed when not in use.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unspecified impurity ≤ 0.5%
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.