Description

Alogliptin Related Compound 23 CAS NO 1618644-29-3 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of pharmaceutical products by serving as a benchmark in impurity profiling and method validation. It is primarily needed by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development and quality control of the antidiabetic drug Alogliptin and its formulations.

Application

• Pharmaceutical Impurity Profiling and Identification as a specified impurity or degradation product of Alogliptin.
• Analytical Method Development and Validation for HPLC, UPLC, and LC-MS assays in quality control laboratories.
• Stability Studies and forced degradation studies to monitor the formation of related substances in drug substances and products.
• Regulatory Compliance and Documentation, providing a certified reference material for regulatory filings (e.g., FDA, EMA).
• Chemical Research as an intermediate or building block in synthetic organic chemistry studies.
• Calibration Standard for quantitative analysis to determine impurity levels against established specifications.

Basic Information

Product Name	Alogliptin Related Compound 23
CAS No.	1618644-29-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Alogliptin Impurity 23; Alogliptin Related Substance 23; 2-({6-[(3R)-3-Aminopiperidin-1-yl]-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl}methyl)benzonitrile; 1-[(2-Cyanophenyl)methyl]-6-[(3R)-3-aminopiperidin-1-yl]-3-methylpyrimidine-2,4(1H,3H)-dione; UNII-Contact for details
EINECS	Contact for details

Quality Control

Our Alogliptin Related Compound 23 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity determination and spectroscopic identification, to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided to guarantee traceability and compliance with ICH guidelines.

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 product is hygroscopic (moisture-sensitive) and must be kept under anhydrous conditions. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%

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