Stability data for shelflife supporting

We have the stability conditions of 25/60, 30/65, 30/75 (As applicable) for the APIs. In case of APIs having storage condition of store in well closed containers/store at ambient condition, then in which storage condition we can generate the stability data and for how much time???

Stability should be in same packaging condition as product marketed. No deviation allowed. Stability perform at defined temp and rH condition. Pl refer ICH, where detailed information available

Just because the API drug substance is stable, does not mean it will be stable in the formulation. One of the largest ‘related substances’ (RS) is a reaction product between the API and the formulation, thus decreasing the drug’s potency and shelf-life (the other RS is a reaction product between the API and the container closure system or packaging)…

Three points is not enough. Try 1, 2, 3, 4, 6, 9, 12, 18, 24 months (2 years). 3 years if applicable, depending on what the originator did. You are COMPELLED to match the stability of the ‘reference listed drug (RLD)’ if manufacturing a generic or OTC.

The storage conditions you should obtain the stability data under will depend on the intended market(s). The required conditions will be determined by the regulatory authorities in each jurisdiction. The Handbook of Stability Testing in Pharmaceutical Development has a chapter on global stability practices.

Dr David Trew
BSc (Hons), PhD, CChem MRSC

David Trew Consulting Ltd
Consultancy services for chemistry based businesses
and laboratory service sectors.

The comments provided here are for information only and are not intended as consultancy advice. Consequently no liability is accepted for any loses incurred as a result of reliance on these comments.

1 Like