Sitagliptin - NDSRI's


Frequently Asked Questions

Controlling Sitagliptin impurities is essential to ensure drug quality, safety, and efficacy. They may harm the drug's performance, potency, stability, and shelf life.

Many techniques are in the literature to quantify Sitagliptin in bulk and formulations. These methods use instruments such as spectrophotometers, high-performance liquid chromatography (HPLC), liquid chromatography-tandem mass spectrometry (LC-MS/MS), high-throughput liquid chromatography-tandem mass spectrometry (HTLC-MS/MS), molecularly imprinted solid-phase extraction (MISPE) coupled with Zwitterionic hydrophilic interaction chromatography (HILIC).

The impurities in Sitagliptin are monitored and tested regularly during drug development, the manufacturing process, and after marketing authorization.

Sitagliptin impurities are stored at a controlled room temperature between 2-8 ⁰C or as indicated on the Certificate of Analysis (CoA).

Note: Products protected by valid patents by a manufacturer are not offered for sale in countries having patent protection. The sale of such products constitutes a patent infringement, and its liability is at the buyer's risk.

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