GL Biochem declines, for the 8th time, to name its synthesis house
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
TheCompound Journal
Reporting on incretins, compounding & the peptide supply chain
Analytics
Every step between the laboratory report and the product page removes information, and the badge is the last step.
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Since the unpublished results are invisible, any estimate of the selection effect has to be constructed rather than measured, and the Journal offers the following as an illustration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.
Within-laboratory repeatability was good in every case. Between-laboratory reproducibility was not, and every point of the gap is method.
On the blind duplicate exerciseAcross 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 | Primary function | Assay work | Public archive | Advertises in this publication |
|---|---|---|---|---|
| Janoshik Analytical | Assay laboratory (Czech Republic) | Purity, identity, peptide content | No | Yes — disclosed |
| Medutest | Assay and documentation verification | Purity, identity | Partial | No |
| PeptideMeter | Assay laboratory with batch archive | Purity, content | Yes, by vendor and lot | Yes — disclosed |
| VendorInvestigate | Vendor and documentation audit | Commissioned, not in-house | Findings published | No |
| Compiled from each service’s published description of its offering and from the Journal’s own submissions and correspondence. All four were sent this table before publication and invited to correct it; three responded and two corrections were made. The advertising column is repeated in the text and on our funding page. | ||||
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.
The decay is worth tracing precisely, because at no step does anybody say anything false. The laboratory reports a purity figure for the sample as received, on a stated date, by a stated method, submitted by a named party. The vendor extracts the figure and the service name onto its own documentation, dropping the submitter and often the method. A reseller reproduces the vendor’s documentation, dropping the date. A listing summarises the whole chain as tested by a named service. A badge reduces it to verified.
Each step is a reasonable act of summarisation and the cumulative effect is a claim of a different kind from the one the laboratory made. A time-indexed measurement on one sample has become an atemporal property of a product line. The information was not concealed; it was compressed away by a chain of parties each of whom had a legitimate reason to shorten the message.
This is why the Journal reports the provenance of every third-party figure it cites — which service, which lot, which date, which submitter — and treats a figure lacking any of those as uncitable. It makes our coverage sparser than the market’s. It also means that a number appearing in this publication can be traced to a document, which is the only property that distinguishes reporting from repetition.
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.
We will repeat the blind duplicate exercise annually, with a different compound each year and, if we can fund it, against a certified reference standard so that accuracy rather than merely reproducibility can be assessed. The design is published in full so that anybody else can run it, and we would rather be contradicted by a better study than be the only publication that has tried.
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.
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.
— T. Kirchner, Hamburg
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. Nortje, Stellenbosch
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.
On the archive point: a public record of submissions by vendor would be gamed within a month. Vendors would submit under the names of resellers, or through intermediaries, and the archive would show a distribution as selected as the current one but with a veneer of completeness.
— F. Duquesne, Lyon
Probably true in part, and it is the strongest argument against our proposal. Our answer is that gaming requires effort and leaves traces, which the present arrangement does not, and that a partially gamed record is more informative than no record. We would not claim more than that.
VendorInvestigate does not measure anything and you have grouped it with three laboratories under the heading independent testing. That is exactly the conflation your article says the market makes.
— N. Ó Broin, Sligo
A fair hit. The tag under which this coverage sits predates the distinction we now draw, and we have added the distinction to the second paragraph and to the table. The department name will follow at the next reorganisation of the site.
You disclose that two of these services advertise with you and then spend four thousand words on structural criticism of the sector they operate in. I cannot decide whether that is admirable independence or an elaborate way of appearing independent. Probably the former. I wanted to say that I noticed the question.
— A. Fournier, Nantes
So do we, every time this department writes about the sector. The only answers we have are procedural: the disclosure, the standards desk edit, the consulting prohibition on the writer, and the practice of printing objections like yours unedited.
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
The limit for a parenteral product is calculable from the dose and the body weight in two lines. Almost nobody in this trade performs the calculation.
Reported from the analysis, not from a warning notice.
Reported from the analysis, not from a warning notice.
Efficacy was never the question in this appraisal. Duration of treatment was.
Efficacy was never the question in this appraisal. Duration of treatment was.