Starting Materials are the building blocks by which drug substances are assembled.  Starting Materials must consistently meet their specifications. However, Starting Materials do not need to be prepared in compliance with GMPs.

All chemical compounds generally have a finite shelf-life

There are no absolute requirements for stand-alone stability studies for Starting Materials. It is generally understood that a Starting Material will meet its specifications at the time of its introduction into the synthesis.

Whether one demonstrates the suitability of the starting material by testing at time of use or by a stability program can depend on its physical and chemical properties. A Sponsor should have a standard operating procedure’in place which details the purchase, storage (including length of time, temperature/humidity, etc.- to match those conditions recommended by the supplier), testing and release for use of all starting materials.

Stability Data

Stability data from a Starting Material supplier can be used in lieu of an in-house stability program, but it is still the Sponsor’s responsibility to verify that the Starting Material meets its specifications at the time of its use in the synthesis.  Retest dates need to be based on real time data, not arbitrary set. A Starting Material in-house retest date cannot exceed a supplier’s expiry/retest date unless stability data is generated to demonstrate otherwise.

Stability data for non-commercially available Starting Materials should be included in the NDA.