vialroom

#coa-reading 2026-02-18

Wednesday15 messages4 participantstimes are UTC
Highlights from this day
  • mhra_unlicensed — if the certificate date precedes the lot date, ask. sometimes it is sloppiness and sometimes it is not, we shall see 13:50
  • mhra_unlicensed — a supplier certificate on its own is a starting point, not evidence. that is the whole reason the verification channel exists, happy to be corrected 14:05
  • fasting_insulin — water content is why an honest 10mg vial assays at 9.1. karl fischer titration, and most certificates omit it 14:08
  • peak_split — an identical chromatogram on two different lots is the single biggest tell there is 16:19
  • peak_split — sterility and endotoxin are separate tests and almost nobody runs either on research material 16:25
MU

if the certificate date precedes the lot date, ask. sometimes it is sloppiness and sometimes it is not, we shall see

MU

a supplier certificate on its own is a starting point, not evidence. that is the whole reason the verification channel exists, happy to be corrected

FI

water content is why an honest 10mg vial assays at 9.1. karl fischer titration, and most certificates omit it

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ask for water content

MU

two certificates from the same supplier have an identical chromatogram, is that normal

[edited]
MU

the related substances table is the interesting part. a row of "not detected" means they did not look hard

no lot number, no certificate. a document you cannot tie to the vial in your hand is decoration

a lab that reports "greater than 98%" rather than a number is telling you they did not integrate carefully

PS

an identical chromatogram on two different lots is the single biggest tell there is

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PS

sterility and endotoxin are separate tests and almost nobody runs either on research material

peak   RRT    area%    note
  1   0.42     0.31    solvent front
  2   0.88     0.44    related substance
  3   1.00    98.72    main
  4   1.14     0.53    related substance

purity is what fraction of the contents is the target. assay is how many mg are actually there. different questions