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Underfilling (revision 2)

Old revision·04:08, 19 Nov 2024·Chromatokid

This is an old revision of this page, as it stood at 04:08, 19 Nov 2024, saved by Chromatokid with the summary add the note that a purity figure without water and counterion is not a mass. It may differ substantially from the current revision, and any error it contains may since have been corrected.
Underfilling
FailureDelivered mass below nominal
Not detected byPurity determination
Detected byGravimetric fill check, or content with fill mass
Topic infobox · conventions

Underfilling is the delivery of less material in a container than the quantity stated on its label. It is a distinct failure from impurity and is invisible to the determination most often supplied: area percent purity is normalised and does not change with the amount of material present.[1]

The quantity a purchaser cares about is the mass of peptide in the vial. That is the product of three things — the fill mass, the peptide content of the solid, and the purity — and a certificate reporting only the last of these constrains it hardly at all.[1]

References

  1. ^ a b United States Pharmacopeia, General Chapter <1503>, Quality Attributes of Synthetic Peptide Drug Substances.