A lyophilised peptide is not stable. It is slow.
We set out what the cycle does, in order, so that a reader can see which of its steps a rushed operation shortens first.
TheCompound Journal
Reporting on incretins, compounding & the peptide supply chain
Incentives
What a verification mark would have to carry to be checkable: a date, a lot, a method, a submitter and a link to the report.
Follow a laboratory report from the bench to a product page and watch the information fall away. The report states a method, a date, a sample identifier, a submitter and a result. The vendor extracts the result. The listing extracts the fact that a result exists. The badge extracts the word verified. At each step the claim gets shorter, more general and more durable, until what began as a measurement on one vial on one day has become a permanent property of a product line, asserted in a graphic that carries no date.
Since the unpublished results are invisible, any estimate of the selection effect has to be constructed rather than measured, and the Journal offers the following as an illustration rather than a finding. Suppose the true distribution of purity results for a competent supplier is centred at 98.0% with a standard deviation of 0.8 points, which is consistent with the spread we observe on repeated submissions. Suppose the supplier publishes results above 98.0% and files the rest.
The published mean is then approximately 98.6%, the published minimum is 98.0%, and the apparent variability is roughly halved. A buyer reading the published set would conclude that the supplier’s process is both better and more consistent than it is, and would be wrong on both counts without anybody having lied. Increase the publication threshold to 98.5% and the published mean rises to 99.0% while the true mean is unchanged.
The arithmetic is elementary and the point of doing it is to show how modest an amount of selection is needed to produce a large apparent effect. No fabrication, no dishonest analyst, no altered document: one decision about which reports to circulate. Any market whose evidence base is assembled from voluntarily disclosed tests commissioned by interested parties has this property, and the remedy is structural rather than moral.
A frequently overlooked asymmetry: none of these services has any authority over a vendor. A laboratory that finds a submitted sample at 91% purity cannot compel a recall, cannot require a retest, cannot publish the finding over the client’s objection without breaching confidentiality, and cannot prevent the vendor from continuing to advertise a figure obtained on a different lot. It can decline further business, which is a real sanction and a slow one.
This is not a shortcoming of the services. Confidentiality to the client is a requirement of the accreditation framework, not an indulgence, and a laboratory that published clients’ results unilaterally would be a worse institution, not a better one. But it means the word verification is doing something the underlying arrangement cannot support: verification in ordinary usage implies a check that can fail with consequences, and here the only consequence of a bad result is that nobody hears about it.
The one structural exception is the public archive. Where a service records that a submission occurred, a vendor cannot quietly discard an unfavourable result, because the fact of the test is on the record even if the detail is not. That is why this article treats the archive as the most important product feature in the sector, and why the Journal’s standing request to all four services is that the existence of a submission be public even where the result is confidential.
A badge is not evidence. It is an assertion that evidence exists, offered without the particulars that would let anybody assess it.
The Journal’s standing positionAcross the four services the Journal has catalogued eleven elements that appear on some reports and not others: the compound and lot as declared by the submitter; the date of receipt; the condition of the sample on arrival; the instrument; the column; the gradient; the detection wavelength; the integration threshold; the reproduced chromatogram; a named analyst; and an explicit statement that results apply to the sample as received.
No service omits all of these and none includes all of them on every tier. The best reports in the sector carry nine or ten and are genuinely good documents by any standard — better, in several respects, than the manufacturer certificates they are checking. The thinnest carry three, and a three-element report is a number with a letterhead.
The reporting requirements in the accreditation standard are the natural benchmark here, and they are not demanding: identification of the items tested, the date of receipt, the methods used, the results with units, and a clear statement of what the results apply to.1 A report meeting that list is checkable. The Journal’s standing request to all four services is a single addition beyond it — print the gradient and the integration threshold — because those two numbers are what make a purity figure comparable with anybody else’s.
| Service | Gradient | Detection | Integration threshold | Result A | Result B |
|---|---|---|---|---|---|
| Service 1 | 15 min generic peptide | 220 nm | not stated | 98.9% | 99.0% |
| Service 2 | 30 min | 214 nm | 0.10% | 98.1% | 98.4% |
| Service 3 | 40 min shallow + orthogonal | 214 nm | 0.05% | 96.8% | 96.9% |
| Twelve vials from one retail lot of a research-grade semaglutide, submitted in pairs three weeks apart under unconnected names. Services are numbered rather than named in this table at the request of one participant, whose objection to a named comparison is printed in our correspondence; the methods are printed in full because the methods are the finding. Within-laboratory agreement was 0.1 to 0.3 points. Between-laboratory spread was 2.1 points, entirely accounted for by the disclosed method differences. | |||||
A verification badge on a product listing typically asserts, in one or two words and a graphic, that the product has been tested by a named service. Consider what that claim leaves open. Which lot was tested. When. Who submitted the sample and how it was selected. What was measured — purity alone, or identity, or content. By what method. Whether the lot currently on sale is the lot that was tested. Whether the report is available to the reader.
Every one of those is material and every one is absent. A badge is therefore not evidence; it is an assertion that evidence exists, offered without the particulars that would let anybody assess it. The Journal does not treat badges as evidence in its coverage, states so wherever it reports one, and will not cite a badge as support for a claim about material.
The remedy is four data points the vendor already possesses: the lot number, the date of analysis, the service, and a link to the report. Several listings in this market already carry them, which establishes both that it is possible and that it is not commercially fatal. What it requires is that a badge become perishable — attached to a lot rather than to a product line — and perishability is precisely the property a marketing asset is designed not to have.
First, publication of submissions rather than only of results: the date, the vendor as named by the submitter, and the compound, with the result confidential where the client requires it. This defeats most of the selection effect and costs nothing.
Second, submitter type on every report — vendor, buyer, publication or reseller — which the laboratory knows and which determines what the result can support. Third, lot-linked badges carrying a lot number, a date and a link, so that a verification claim expires with the lot it describes. Fourth, gradient and integration threshold printed on every purity report, which is the only way two figures from different services can be compared at all.
None of the four requires a regulator, new legislation, or any change in analytical practice. Three of them require a laboratory to print information it already holds; the fourth requires a vendor to accept that a badge should perish. The Journal has put all four to each of the services covered here. Responses have been mixed and mostly constructive, and are printed in our correspondence pages as they arrive. We will publish an annual note on which have been adopted, because the alternative is making the same request indefinitely without recording the answer.
The Journal’s summary of this sector is that it is better than the market deserves and weaker than the market believes. Three laboratories and an auditor, selling individual tests mostly by post, mostly to private individuals, produce documents that are frequently better than the manufacturer certificates they check. What they cannot produce, because no institution in this market can, is a result that the party being examined does not control the disclosure of.
Selected from correspondence received on this article. Writers are identified by initial, surname and city, verified before printing. Replies are from the desk that filed the piece or from the standards editor. Write to letters@compoundjournal.com.
I run analytical services and I object to the framing of your blind comparison. You bought our cheapest tier, published the number it produced alongside a competitor’s most thorough package, and called the result a spread. It is not a spread. It is three different products, priced accordingly, and your own table says so two columns to the right of the headline figure.
— D. Ó Súilleabháin, Killarney
This is the objection we thought was most likely and we think it is partly right. The comparison is of standard products at standard prices, which is what buyers actually purchase, and we said so. But the presentation invites the reading you object to, and the figure caption now states the tier alongside each result rather than leaving it to the method columns.
I submitted a vial to one of these services last year, got a result three points below what the vendor advertised, and did not know what to do with it. Your article explains why: I had one measurement on one vial, no method comparison, and no way to know if my vial was representative. I still do not know what to do with it, but I understand the shape of not knowing.
— K. Mwangi, Nakuru
That is a better summary of this article’s practical content than our own closing paragraphs. The one thing we would add is that your result is worth publishing wherever you can, because buyer-submitted results are the scarcest and most informative category in the entire corpus.
The price table is the most useful thing you have published this year and also the thing most likely to be quoted out of context by somebody selling a comparison service. You might consider a note.
— R. Cadogan, Bridgetown
There is one, and we have strengthened it. The figures are what this publication was invoiced at list rates and are not quotations a reader should expect; volume submitters pay materially less.
You note that no service offers sterility testing and that it takes fourteen days. Worth saying more plainly: a purity certificate and a sterility assurance are not merely different tests, they are different disciplines with different facilities, and no amount of chromatography will ever bear on it.
— S. Ó Ceallaigh, Limerick
Correct and worth the emphasis. We have said it in the certificates piece and should say it here too: nothing any of these four services sells addresses sterility, endotoxin or container closure integrity, and no combination of their reports adds up to one.
We set out what the cycle does, in order, so that a reader can see which of its steps a rushed operation shortens first.
A result on one vial generalises to a batch only if the vial was drawn in a way that makes it representative — and nobody records how it was drawn.
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
The Journal submitted split samples from single lots to three assay services, under names unconnected to this publication, and published each method alongside each result.
The Journal submitted split samples from single lots to three assay services, under names unconnected to this publication, and published each method alongside each result.
Efficacy was never the question in this appraisal. Duration of treatment was.