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Answer Posted / navinpatel
Many pharmaceutical substances undergo changes in presence
of light. Photo stability study is performed to evaluate
and demonstrate that light exposure does not result in
unacceptable change in new drug substances and products.
Mostly the testing is carried out on a single batch of API
or product. If any changes or variation is done in current
product like change in formulation or packing these study
should be repeated. Wheatear the study should be repeated
or not depends upon the initial results of photostability
study.
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