Module 3 2019

Finally….A Possible Long Term Stability Conditions for Solid Dosage Formulations decision tree

Start

Is Information Regarding API Moisture Sensitivity Available?

Is Primary DP Packaging Impermeable

Collate/Investigate API Properties

Yes

No

No

Confirm Impermeable* Packaging Claim Defendible

Yes

Hydrolysis Oxidation Reduction

Is API Susceptible to Degradation During Stability?

Racemization Polymorphism Physical

Yes

Initiate Long Term Stability (30°C/65%RH) OR (30°C/75%RH)

No

API-Excipient Interactions Forced Degradation

Is DP Susceptible to Degradation in Selected Packaging During Stability

Propose Impermeable DP Packaging

End

Yes

Confirm Impermeable* Packaging Claim Defendible

No

Initiate Long Term Stability (30°C/65%RH) OR (30°C/75%RH)

*Defined as impermeable to moisture, light, oxygen as appropriate, dependent on physico-chemical evaluation of drug substance/product *Defined as imper eable to moisture, li t, x s r ri t , dependent on physico-che ical eval ati f r s t / r

End

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