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What is photo stability?
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Answer / sitaramaraju kantasputhy
Photo stability is a study to evaluate the resistance of product in presence of light.Which is a part of stability study and forced degradation study, where we are testing sample by exposing sample to UV light (Not less than 1.2 million lux hrs)(UV (Xenon)lamp D65)on Drug substances or drug products or with primary packaging or Marketed pack.
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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.
| Is This Answer Correct ? | 4 Yes | 1 No |
Answer / pandit kakde
Photostabilty study is measure of How the quality of drug substance and drug product influence by light... With a exposure to definite uv radiation(about 1.2 million Lux hours) .it is carried out on single batch of Api or drug product. Study is carried out at the development stage to determine the degradation profile elucidation and after change in formulation or packaging material.....
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