Sitagliptin -SIL NDSRI
References
FAQ's
References
- Edmondson, Scott D.; Fisher, Michael H.; Kim, Dooseop; MacCoss, Malcolm; Parmee, Emma R.; Weber, Ann E.; Xu, Jinyou, Beta-amino heterocyclic dipeptidyl peptidase inhibitors for the treatment or prevention of diabetes, Merck & Co., Inc., United States, US6699871B2, March 2, 2004
- Nirogi, Ramakrishna; Kandikere, Vishwottam; Mudigonda, Koteshwara; Komarneni, Prashanth; Aleti, Raghupathi; Boggavarapu, Rajeshkumar, Sensitive liquid chromatography tandem mass spectrometry method for the quantification of sitagliptin, a DPP-4 inhibitor, in human plasma using liquid-liquid extraction, Biomedical Chromatography, Volume: 22, Issue: 2, Pages: 214-222, 2008
Frequently Asked Questions
Why is it essential to control Sitagliptin impurities?
Controlling Sitagliptin impurities is essential to ensure drug quality, safety, and efficacy. They may harm the drug's performance, potency, stability, and shelf life.
What are the different analytical techniques used to quantify Sitagliptin and its impurities?
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).
How often are Sitagliptin impurities monitored and tested?
The impurities in Sitagliptin are monitored and tested regularly during drug development, the manufacturing process, and after marketing authorization.
What are the temperature conditions required to store Sitagliptin impurities?
Sitagliptin impurities are stored at a controlled room temperature between 2-8 ⁰C or as indicated on the Certificate of Analysis (CoA).
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