How to find the expiry date for a Formulation or API molecule
How to find the expiry date for a Formulation or API molecule?
On what basis we will give the expiry date and what are the analytical and technical assessments we need to do for its confirmation
Replies to this topic (3)
On the basis of stability studies of drug or product wll decide the expiry date
Here, to attain the expiry date for an API molecule or a formulation, we must study the drug under accelerated conditions (40°C, 75%RH) for at least 6 months to give it's a tentative date for expiry/retest.
Along with accelerated conditions, the drug or the molecule must be tested for long-term conditions to give it's a permanent expiry date.
Here, we should consider that the long-term condition will be done at 25°C, 60% RH where as accelerated study is done in extreme conditions (40°C, 75%RH).
you could attest 2 years expiry for the substances with this minimum data of accelerated conditions. As it is tentative, the actual retest or expiry will be given by long- term data as long as the drug/Formulation meets the specification.
Analysis Evaluate Against Specifications
Execute the Sampling Timeline
Select Climatic Zones & Chamber Setup.
Long-Term Testing
Accelerated Testing
Intermediate Testing