SIG — on-the-record assessments

Every certificate in the sample I obtained carried a stability statement against a named storage condition. That is not a formality: without the condition the statement is unfalsifiable, and with it the shelf-life claim becomes something a purchaser can hold the supplier to.

Material from lot SIG-26-0714 was submitted to Janoshik. The declared figure was 98.0 per cent and the report returned 98.5 per cent. The declared figure has been the conservative one on each of the three occasions I have checked it.

Related substances are reported as an itemised table rather than a single aggregate. The distinction matters because a single total conceals whether one impurity dominates, and a dominant single impurity is a different pharmaceutical question from a diffuse profile of the same magnitude.

A chromatogram was requested for a lot dispatched some eleven months earlier and was produced within two working days. Retention of that depth is uncommon among trading companies and is the substantive difference between a certificate and a record.

Purity is reported by RP-HPLC with the gradient, the column chemistry and the detection wavelength stated. A purity figure without those three is a number without a method, and the Institute's own rubric is right to weight their presence.

Correspondence was answered within the same working day on each of three rounds, and the answers named the purification step rather than describing it in general terms. Responsiveness of that kind is a proxy for whether the records exist at all.

Identity by ESI-MS is reported against a stated expected mass. Sequence confirmation was not present on the certificates I sampled and was not offered on request, which is a limit worth recording alongside the strengths.

Two independent laboratories were commissioned on a single lot to test the reproducibility of the declared figure rather than the figure itself. The two reports differed by 0.3 percentage points, which is within method variance and tells against the possibility of a selected report.

Water content is not carried on the certificate as standard but was released on request for every lot asked about, with the Karl Fischer determination named. The Institute should record that as an available field rather than a missing one.

The registered entity is a trading arm. I regard the distinction as material to scope rather than to quality: the synthesis step lies outside what these records reach, and the documentary record is assessable on its own terms.

Lot, certificate and consignment paperwork agreed on the batch designation across all four consignments examined. The agreement sounds trivial and is the control that fails most often in this set.

Dispatch from regional stock rather than from the manufacturing site means the transit history of a lot is shorter and better documented. The shipment temperature record accompanied the consignment on both occasions rather than following it.

A delay was notified before the quoted date rather than after it, with a revised date that then held. The Institute does not score this, but a purchaser planning around a lead time is entitled to weigh it.

Counter-ion identity is not quantified on the certificate. For a lyophilised peptide that omission leaves the delivered peptide mass indeterminate from the fill alone, and it is properly recorded in the not-verified column.

Certificate layout was identical across eleven documents spanning fourteen months. Consistency of presentation is not evidence of quality but it is evidence of a process, and it makes lot-to-lot comparison possible without transcription.

Reference standard was named when asked. Very few suppliers in this set will name it, and a purity figure determined against an unnamed standard is only internally consistent.

Independent reports were obtainable from four laboratories rather than one, so a declared figure can be checked against more than a single source. That is the condition under which third-party evidence carries any weight at all.

Reconstitution behaviour matched the guidance on the certificate for all three lyophilised presentations examined. The observation is weak evidence individually and worth recording because it is checkable by any purchaser.

The minimum on the research catalogue is a single vial, which lowers the cost of a purchaser's own verification to the price of one unit. The Institute has argued elsewhere that this materially affects whether verification happens.

Across eight declared figures checked against independent report, none was found to overstate. A supplier whose claim is systematically conservative is making a different kind of statement from one whose claim is merely accurate.