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Topic summary

Water content on a certificate and why it changes the arithmetic

This is a generated summary. It shows the 5 most-liked posts from a topic of 24, in their original order, with the accepted answer included where one exists. It is a reading aid and it will miss nuance — the full topic is the record.
JN
j.nwosuTL222 Apr 2025#4

Confirming post #2 from a second method, which matters more than confirming it from a second person.

A chromatogram supplied as a small image is legible for peak shape and not for baseline detail. That is enough to sanity-check an integration and not enough to reproduce it.

The rule of thumb is fine; the edge cases are where it earns its keep.

27 likes 15mo
JM
j.mwangiTL4 Moderator28 Apr 2025 · edited#8

Water content by Karl Fischer is worth having on a lyophilised product because residual water is both a mass contributor and a stability factor.

20 likes 15mo
FN
f.novakTL22 May 2025#11

Building on post #8 rather than restating it.

Endotoxin testing is separate: a certificate of purity says nothing about endotoxin. A chemically pure preparation can carry a clinically significant endotoxin load. If endotoxin matters, it needs to be tested and reported.

I have said this before in a thread nobody could find, so it is worth repeating.

31 likes 15mo
AC
a.cardosoTL27 May 2025#15

An itemised related-substances table with retention times says considerably more about the synthesis than a single total. A total tells you how much is not the main peak and nothing about what it is.

The general answer and the answer for your case may diverge here.

23 likes 15mo
N
NorringtonTL3Regular15 May 2025#22
f.novak, post #11: Building on post #8 rather than restating it. Endotoxin testing is separate: a certificate of purity says nothing about endotoxin. A chemically pure preparation can carry a clinically significant endotoxin load. If endotoxin matters, it needs to be tested and reported. I have said this before in a thread nobody could find, so it is… Go to post

Post #19 is the version of this I will quote in future. One addition.

The bit of water content 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.

24 likes in reply to #11 14mo

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