I want to know about hold time study and stability study, please provide the details

Quality Assurance
1

Dear sir

i want to know about hold time study and stability study, please provide the details

2

Hold time study data is give us the assurance the maximum
allowable hold times for bulk and in-process drug products.

Stability testing is to provide evidence of
how the quality of Finished Pharmaceutical Product (FPP) varies
with time under the influence of a variety of environmental
factors such as temperature, humidity and light in proposed packaging presentation.

Is this general question or related to any specific dosage form ?

3

general question

4

sir what is stress testing ?

5

Stress testing of the drug substance can help us to identify the likely degradation products & Its pathways (End product) and the intrinsic stability of the molecule and validate the stability indicating power of the analytical procedures used for the stability testing.

Stress study conducted as follwoing manner . However based on dosage,type of administration, type of storage condition it will varies.

  1. temperature ( in 10°C increments e.g., 50°C, 60°C above that for accelerated testing)
  2. humidity (75 % relative humidity or greater)
  3. At different pH
  4. Photostability(light )
6

please raise sub- question in main question column only.