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Underfilling (revision 4)

Old revision·02:43, 2 Dec 2024·ReportReaderRilla

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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]

Why purity does not detect it

[edit]

Chromatographic purity is computed as the area of the main peak divided by the total integrated area, expressed as a percentage. Both terms scale with the amount injected, so the ratio is invariant to concentration over the linear range of the detector.[2]

A consequence is that a half-filled vial and a correctly filled vial of the same material give the same purity figure. The determination is answering a question about composition, and fill is a question about quantity.

References

  1. ^ a b United States Pharmacopeia, General Chapter <1503>, Quality Attributes of Synthetic Peptide Drug Substances.
  2. ^ United States Pharmacopeia, General Chapter <621>, Chromatography.