| Sumario: | The underlying concept for acceptance value (AV) in <905> Uniformity of Dosage Units (UDU) is based on that of tolerance interval (TI). Its maximum allowed acceptance value (L1) is declared not more than (NMT) 15; therefore, meeting the limit will just imply that the lower the value the higher the degree of quality conformance. Due to the formula for L1 or AV (i.e., AV = |M -- x| + ks ≤ 15, the condition for is not justified, and so, compromising that, the AV results will easily pass the limit of NMT 15 most of the time. If recognized by United States Pharmacopeia, such a compromization will continue for official use in a new proposal on "Batch Release Testing for Ensuring Compliance with Uniformity of Dosage Units". One of the solutions for such a compromization issue is to simply implement the TI technique to demonstrate that at least 95% or more of the dosage units in routine batches will fall within the range 85-115% of label claim. The technique will provide useful data for batch releasing rather than depending on AV parameter alone.
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