Description

Alogliptin Related Compound 24 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient Alogliptin, a medication for type 2 diabetes. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, impurity profiling, and quality control processes.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Alogliptin API batches.
• Analytical Method Development and Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods to ensure accurate impurity detection.
• Quality Control (QC) and Quality Assurance (QA): Employed in routine QC testing to monitor and control impurity levels, ensuring final drug product compliance with ICH guidelines.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) submitted to agencies like the FDA and EMA.
• Stability Studies: Helps in tracking the formation of degradation products under various stress conditions, supporting shelf-life determination.
• Pharmacopoeial Standards: Can be used to support compliance with pharmacopoeial monographs (e.g., USP, EP) for Alogliptin.

Basic Information

Product Name	Alogliptin Related Compound 24
CAS No.	1430222-06-2
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 24; TAK-875 Related Compound; 1430222-06-2; UNII-7V3N86A5WJ; Benzonitrile, 2-[[6-[(3R)-3-amino-1-piperidinyl]-3-methyl-2,4-dioxo-1(2H)-pyrimidinyl]methyl]-; (R)-2-((6-(3-Aminopiperidin-1-yl)-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)methyl)benzonitrile
EINECS	Contact for details

Quality Control

Our Alogliptin Related Compound 24 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis and spectroscopic identification (NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. Keep the container sealed to protect the material from moisture.

Specification

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

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