Why does SMTL recommend testing 3 batches ?
For new products and regular testing SMTL recommend preliminary testing followed by inhibition/enhancement studies on three separate lots before routine analysis. This is based on the USP and FDA recommendation of testing a minimum of 3 and a maximum of 10 batches for both inhibition/enhancement and routine testing. Extracts can be tested separately or pooled (which is cheaper). For one-off testing, a single sample preliminary validation can be carried out and the endotoxin result used as an indication of the content. (This question last updated on the 9-4-97, by pete@smtl.co.
