Module 3 - Strategic case studies in practice

Example-1  A fixed-dose combination IR tablet:

– API-1: ~80% of the tablet weight – API-2: ~1% of the tablet weight – Diluent (microcrystalline cellulose): ~ 14% of the tablet weight – Other excipients: disintegrant, colorant, and lubricant – Content Uniformity (CU) of API-2 is a high risk CQA

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