Analytics · Impurities & related substances · continued

Endotoxin and why it is a separate question from purity — what changed since posts 91–92

Analytics › Impurities & related substances HPLC endotoxin testing data table forced degradation

This is a continuation of a long topic, addressed by post number rather than by page. Start at post 1.

l.aaltonenTL3Regular27 Jul 2026#91

Agreed on Endotoxin, with one qualification that I think matters. The reasoning holds for the case as described. Change the starting assumption and it does not, and the starting assumption is the part nobody states.

0 likes 1d

ca.vermeulenTL227 Jul 2026#92

e.mbeki, post #5: The bit of Endotoxin that nobody enjoys is that the answer changes depending on what you are trying to decide with it. Say what the decision is and the thread will converge. Go to post

The arithmetic in post #91 is right; the assumption feeding it is the part to check.

That last point is the ceiling on what any purity figure can claim. A method that cannot see a species cannot exclude it, and no certificate says which species its method cannot see.

26 likes in reply to #5 10h

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Attributing a new peak: degradation product or excipient?Analytics › Impurities & related substances · 2 replies

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