Vildagliptin - NDSRI's

Vildagliptin Nitroso impurity

  • CAT Number DCTI-C-1843
  • CAS Number NA
  • Molecular Formula C17H24N4O3
  • Molecular Weight 332.4

Frequently Asked Questions

Controlling impurities in Vildagliptin ensures the drug’s quality, safety, and efficacy. They can affect Vildagliptin stability, pharmacological activity, and toxicity and interfere with the analytical methods used for its detection and quantification.

High-performance liquid chromatography-mass spectrometry helps accurately measure the levels of the impurities in Vildagliptin.

Regulatory agencies like the US FDA, EMA, and ICH establish acceptable limits for impurities in Vildagliptin. The limits may vary depending on the impurities ensuring that Vildagliptin meets stringent standards for its quality and suitability for patient use.

Impurities in Vildagliptin are controlled during the synthetic process by implementing good manufacturing practices (GMP) and using appropriate analytical methods for impurity identification and quantification.

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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