Description

Alogliptin Benzoate is a high-purity active pharmaceutical ingredient (API) used in the treatment of type 2 diabetes. It functions as a potent and selective dipeptidyl peptidase-4 (DPP-4) inhibitor, helping to regulate blood glucose levels. This compound is essential for pharmaceutical manufacturers developing oral anti-diabetic medications. Its consistent quality and reliable supply are critical for ensuring the safety and efficacy of the final drug product.

Application

• Pharmaceutical API: Primary active ingredient in the formulation of oral anti-diabetic drugs (e.g., Nesina®).
• DPP-4 Inhibitor Development: Key component in research and development of novel incretin-based therapies.
• Fixed-Dose Combination Drugs: Used in combination with other anti-diabetic agents like metformin or pioglitazone.
• Reference Standard: Serves as a high-purity standard for quality control and analytical testing in pharmaceutical laboratories.
• Clinical Trial Material: Supplied as a critical raw material for manufacturing investigational medicinal products.
• Generic Drug Manufacturing: Essential for the production of generic versions of alogliptin-containing medications post-patent expiry.

Basic Information

Product Name	Alogliptin Benzoate
CAS No.	850649-62-6
Molecular Formula	C25H27N5O4
Molecular Weight	461.52 g/mol
Synonyms	Alogliptin Benzoate Salt; 2-({6-[(3R)-3-Aminopiperidin-1-yl]-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl}methyl)benzonitrile monobenzoate; SYR-322 Benzoate; Nesina (trade name base); (R)-2-((6-(3-aminopiperidin-1-yl)-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)methyl)-4-fluorobenzonitrile benzoate
EINECS	Contact for details

Quality Control

Our Alogliptin Benzoate is manufactured under strict quality management systems, targeting compliance with current Good Manufacturing Practices (cGMP) and ICH Q7 guidelines. Each batch undergoes comprehensive analytical testing, including identification, assay, impurity profiling, and residual solvent analysis, to ensure it meets stringent pharmaceutical-grade specifications. A Certificate of Analysis (COA) documenting all test results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption, which can affect stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Conforms to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Specific Rotation	Contact for details

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