General Information

Saxagliptin Impurities and Saxagliptin  

Daicel Pharma is a reliable source for synthesizing high-quality Saxagliptin impurities, specifically N-Boc-3,4-dihydroxy-(S)-adamantyl glycine, N-Boc-adamatyl glycine, Saxagliptin diastereoisomer-R, S, S, S, Saxagliptin diastereoisomer-S, R, S, S, Saxagliptin Imine Impurity, and Saxagliptin isomers-R, R, R, R. These impurities aid in evaluating Saxagliptin’s quality, stability, and safety. Daicel Pharma also provides a custom synthesis of Saxagliptin impurity standards that can be shipped anywhere worldwide to meet clients’ requirements.

Saxagliptin [CAS: 361442-04-8] is an oral antidiabetic medication belonging to the class of dipeptidyl peptidase-4 (DPP-4) inhibitors. It treats type 2 diabetes mellitus.

Saxagliptin: Use and Commercial Availability   

Saxagliptin is an oral antihyperglycemic agent used to lower blood sugar levels in individuals with type 2 diabetes mellitus. It improves glycemic control with other diabetes medications such as metformin, sulfonylurea, or long- or intermediate-acting insulin (with or without metformin). Saxagliptin helps lower blood sugar levels by increasing the levels of GLP-1 and GIP. Saxagliptin is available under Onglyza.

Saxagliptin Structure and Mechanism of Action

The chemical name of Saxagliptin is (1S,3S,5S)-2-[(2S)-2-Amino-2-(3-hydroxytricyclo[3.3.1.13,7]dec-1-yl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile. Its chemical formula is C₁₈H₂₅N₃O₂, and its molecular weight is approximately is 315.4 g/mol

Saxagliptin is a DPP4 inhibitor that inactivates incretin hormones. It reduces fasting and postprandial glucose concentrations in patients with type 2 diabetes mellitus.

Saxagliptin Impurities and Synthesis

Saxagliptin’s manufacturing process¹ can develop impurities, which could diminish its effectiveness. They may come from various raw materials, intermediates, and chemicals used for Saxagliptin synthesis. It is necessary to manage and monitor these contaminants closely to ensure the drug’s effectiveness and safety.

Daicel Pharma offers a Certificate of Analysis (CoA) from a cGMP-compliant analytical facility for Saxagliptin impurity standards such as N-Boc-3,4-dihydroxy-(S)-adamantyl glycine, N-Boc-adamatyl glycine, Saxagliptin diastereoisomer-R, S, S, S, Saxagliptin diastereoisomer-S, R, S, S, Saxagliptin Imine Impurity and Saxagliptin isomers-R, R, R, R, and more. The CoA includes complete characterization data, such as 1H NMR, 13C NMR, IR, MASS, and HPLC purity². We also provide 13C-DEPT on request. Upon delivery, we give a complete characterization report. Daicel Pharma has the technology and expertise to prepare any unknown Saxagliptin impurities or degradation products.