Consequences of New Approach of Chemical Stability Tests of Active Pharmaceutical Ingredients (APIs)

Marzena Jamrógiewicz

doi:https://doi.org/10.3389/fphar.2016.00017

Consequences of New Approach of Chemical Stability Tests of Active Pharmaceutical Ingredients (APIs)

Abstrakt

There is a great need of broaden look on stability tests of active pharmaceutical
ingredients (APIs) in comparison with current requirements contained in pharmacopeia.
By usage of many modern analytical methods the conception of monitoring the changes
of APIs during initial stage of their exposure to harmful factors has been developed. New
knowledge must be acquired in terms of identification of each degradation products,
especially volatile ones. Further research as toxicology prediction during in silico studies
of determined and identified degradation products is necessary. In silico methods
are known as computational toxicology or computer-assisted technologies which
are used for predicting toxicology of pharmaceutical substances such as impurities
or degradation products. This is a specialized software and databases intended to
calculate probability of genotoxicity or mutagenicity of these substances through a
chemical structure-based screening process and algorithm specific to a given software
program. Applying of new analytical approach is proposed as the usage of PAT tools,
XRD, HS-SPME GC-MS/MS, LC-MS/MS for stability testing. Described improvements
should be taken into account in case of each drug existing already in the market as well
as being implemented as new one.