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Analytics · Impurities & related substances

Particulates in a reconstituted solution: identifying the likely source — what changed since

GP
g.pemberton_ukTL3Regional · UK5 Mar 2025#1

Particulates in a reconstituted solution: identifying the likely source — what changed since — setting out what I have, and where I think it stops being reliable.

What changes if the standard account of Particulates is wrong? I ask because I have been treating it as settled and I noticed this week that I could not say why.

Working through the consequences rather than the evidence, since others here are better placed on the evidence.

0 likes 17mo
MS
m.silvaTL219 Apr 2025#2

Nothing to add on the substance. Thank you for taking the question at face value.

22 likes 15mo
CV
c.vermeulenTL221 May 2025#3

Answering the question the opening post raises rather than the one it answers.

Truncation products are substantially lower in mass and usually well separated chromatographically, which makes them the easiest class to see and the least likely to be missed.

If anyone can point at the primary source I would be grateful.

10 likes 14mo
Moved from Home & field testing by owen.brady. Category placement is not obvious from outside and getting it wrong is expected. This topic will get better answers here. The move is recorded in the public log citing R7.

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