Key Starting Material (KSM) can be any pharmaceutical raw
material, API, or an intermediate solely used for the
production of API. It contributes to the structure of the API. The
chemical properties and structure of a KSM are defined.
Pharmaceutical intermediates are the intermediate
compounds necessary in API production, referred to as the
building blocks of APIs. As the production progresses, they
get released as by-products, which serves as the precursor
to other APIs. Unlike APIs, intermediates may not have
therapeutic effects and can be toxic. The refinement
process converts intermediates to API by changing the
molecular structures in each step.
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