Stratified Content Uniformity vs Conventional Content Uniformity
Content Uniformity (CU) is one of the most critical quality attributes for solid oral dosage forms, particularly for low-dose and high-potency products. However, misunderstanding still exists between Conventional CU and Stratified CU, especially during failure investigations. 1. Conventional Content Uniformity evaluates batch compliance Conventional CU is a pharmacopeial requirement performed as per USP <905> or…
