stability testing and prediction of shelf life Flashcards

1
Q

prediction shelf life

A
  1. order reaction
  2. degradation rate constant
    3 calculate t0.9
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2
Q

what is accelarated stability study

A

the technique used in preformulation stage to identify the suitable formulation.

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3
Q

new drug protocol

A
  1. long term testing
  2. intermediate testing
  3. accelerated testing
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4
Q

define shelf life

A

shelf life is the time when the api and fpp is remain and no degradation durung the shelf life

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