PeptidePedia The community reference

Underfilling (revision 3)

Old revision·20:24, 20 Nov 2024·Ref_Desk_Ron

This is an old revision of this page, as it stood at 20:24, 20 Nov 2024, saved by Ref_Desk_Ron with the summary clarify that a QR code on a certificate proves issuance, not content. 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]

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.