Formation of N-nitrosodimethylamine during the Storage of ranitidine reagent powder

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Temperature-dependent formation of N-nitrosodimethylamine in the course of the storage of ranitidine reagent powders and tablets

The aim of this research was to elucidate the impact of high-temperature storage on the steadiness of ranitidine, particularly with respect to the potential formation of N-nitrosodimethylamine (NDMA), which is classed as a possible human carcinogen.
Commercially obtainable ranitidine reagent powders and formulations have been saved beneath numerous situations, and subjected to LC-MS/MS evaluation. When ranitidine tablets from two completely different manufacturers (designated as pill A and pill B) have been saved beneath accelerated situation (40°C with 75% relative humidity), following the drug stability pointers issued by the Worldwide Convention on Harmonisation (ICH-Q1A), for as much as eight weeks, the quantity of NDMA in them considerably elevated from 0.19 to 116 ppm and from 2.89 to 18 ppm, respectively.
The formation of NDMA that exceeded the appropriate each day consumption restrict (0.32 ppm) on the temperature used beneath accelerated storage situations clearly highlights the danger of NDMA formation in ranitidine formulations when extrapolated to storage beneath ambient situations.
A forced-degradation research beneath the stress situation (60°C for 1 week) strongly instructed that environmental elements comparable to moisture and oxygen are concerned within the formation of NDMA in ranitidine formulations. Storage of ranitidine tablets and reagent powders on the excessive temperatures additionally elevated the quantity of nitrite, which is taken into account one of many elements influencing NDMA formation.
These information point out the need of controlling/monitoring stability-related elements, along with controlling impurities in the course of the manufacturing course of, with a view to mitigate nitrosamine-related well being dangers of sure prescribed drugs.

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