COA School
Field 1
Issuing laboratory
What it is
The header names the laboratory that ran the analysis and issued the certificate. The WHO model certificate of analysis puts the name and address of the issuing laboratory first, and gives each certificate its own identification number, printed on every page with the page number and total number of pages.
What to check
Look the laboratory up yourself, not through a link on the certificate. It should have its own website, an address and a way to contact it. If the certificate was reissued by a seller or agent, it should still name the laboratory that actually performed the analysis.
Red flag
A seller's logo where the laboratory should be, or a laboratory name you cannot find anywhere else. ICH Q7 says certificates reissued by agents or brokers should show the name, address and telephone number of the laboratory that performed the analysis (ICH Q7, 11.44).
The nine fields, one by one
1.Issuing laboratory
The header names the laboratory that ran the analysis and issued the certificate. The WHO model certificate of analysis puts the name and address of the issuing laboratory first, and gives each certificate its own identification number, printed on every page with the page number and total number of pages.
Check: Look the laboratory up yourself, not through a link on the certificate. It should have its own website, an address and a way to contact it. If the certificate was reissued by a seller or agent, it should still name the laboratory that actually performed the analysis.
2.Sample description
This block says what was received: the product name, the label claim, the type of container and the quantity received. The WHO model certificate also expects the number the laboratory assigned to the sample on receipt, and allows a photograph of the packaging or product tested (WHO model certificate).
Check: Compare the description with your own vial: the compound name, the label claim in milligrams and the vial format. If there is a photograph, check that the label in it looks like yours.
3.Batch or lot
The batch or lot code ties the result to a production run. ICH Q7 defines a batch as material expected to be homogeneous within specified limits, and a batch number as a unique combination of numbers, letters or symbols that identifies it. ICH Q7 also says a certificate should give the batch number.
Check: Read the code on the certificate character by character against the code on your vial or box. Letters such as O and 0, or I and 1, are easy to misread, so check twice.
4.Dates: received, analysed, issued
A certificate should show when the sample arrived, when it was analysed and when the report was issued. The WHO model certificate lists the date the sample was received, and ICH Q7 says certificates should be dated.
Check: Put the dates in order. A sample is received, then analysed, then reported, so the dates should run in that order. Then compare them with when your batch could have existed: a certificate dated before the batch was made cannot describe it.
5.Method
Each result should name the method that produced it, such as HPLC with UV detection for purity or mass spectrometry for identity. The WHO model certificate expects a reference to the test procedure used and the acceptance criteria for each test (WHO model certificate).
Check: Match each result to a method. Check that the method can answer that question: ICH Q2(R2) treats identification, assay and purity as different kinds of test, each needing its own evidence that the procedure is fit for purpose. The methods library explains the common methods in plain English.
6.Identity result
Identity answers whether the molecule in the vial is the one on the label. For peptides it is usually shown by mass spectrometry: the mass the laboratory expected for the named peptide and the mass it observed.
Check: Look for both numbers, expected and observed, and check that they agree. Then check the expected value against a public reference for the compound, such as its PubChem record. ICH Q2(R2) notes that an identification test must be able to tell the analyte apart from closely related compounds.
7.Purity result
Purity is usually reported as an HPLC percentage: the main peak's share of the total peak area the detector recorded. It describes the peptide relative to related impurities that the method separated and detected, not everything in the powder.
Check: Check that purity is reported with its method and, ideally, a chromatogram. Check the number of decimal places is sensible: ICH Q3A(R2) asks for impurity results to be reported to two decimal places below 1.0% and to one decimal place at and above it, and notes that decimal places used for thresholds do not necessarily reflect a procedure's precision.
8.Amount result
Amount, sometimes called assay or content, is how many milligrams of the peptide the vial actually held, measured against a reference standard of known content. It answers whether the vial matches its label claim.
Check: Compare the measured milligrams with the label claim and with any acceptance range the certificate states. Check the units: milligrams per vial is not the same as a percentage, and a percentage of label claim is not the same as purity. A vial can be very pure and still hold less peptide than its label says.
9.Signature and verification
The certificate should be signed and dated by the person who approved it, and offer a way to confirm it with the issuer. In the Philippines, RA 10657 Section 40 says a document related to the practice of chemistry is official or admissible for legal purposes only if signed by a registered chemist with the registration number affixed; Section 33 adds the chemist's seal. What else Philippine law says about certificates is in testing in the Philippines.
Check: For a Philippine certificate, check the chemist's name and registration number with the PRC online verification. For any certificate, use the verification route on the laboratory's own site, reached independently, and compare what it shows with your copy.
Fifteen red flags. Each is a question to ask, never proof on its own.
1.No batch number
Without a batch or lot code, a certificate cannot be tied to any production run, so it cannot be evidence about your vial. ICH Q7 expects a certificate of analysis to state the batch number, and the WHO model certificate lists it in the sample description. A certificate with a compound name and a purity figure but no batch is describing a sample nobody can identify. Treat it as an example of what the product could be, not as a record of what you bought.
2.Batch does not match the vial
The certificate names a batch, but it is not the batch printed on your vial or box. However genuine the certificate is, it describes a different production run. Compare the codes character by character, since letters and digits such as O and 0 are easy to confuse. If they differ, ask the seller for the certificate that matches your batch, or have your own sealed vial analysed.
3.The same report shown for several batches
One certificate, with the same identification number, results and dates, is offered for more than one batch, sometimes with only the batch code changed. ICH Q7 says certificates should be issued for each batch, and the WHO model certificate gives each certificate its own identification number. If two certificates share every number except the batch, at least one of them is unlikely to describe a real analysis of that batch.
4.Cropped, or only a screenshot
You are shown a cropped image or a screenshot rather than the full document. Cropping often removes exactly what you need: the laboratory header, the sample number, the date or the signature. The WHO model certificate puts an identification number, the page number and the total number of pages on every page, so a complete certificate shows that nothing is missing. Ask for the full PDF from the laboratory.
5.No way to verify it
The certificate offers no task number, key, code or other route to confirm it with the laboratory that issued it. Anyone can make a convincing document; what makes it evidence is that the issuer will confirm it is theirs and unchanged. If there is no verification route, contact the laboratory directly using details you found yourself and ask whether it issued that certificate.
6.The verification link goes to the seller's website
A QR code or link that is supposed to verify the certificate opens a page on the seller's own domain, not the laboratory's. A seller controls its own website, so a page there confirms nothing independently. Verification only counts when it comes from the issuer. Find the laboratory's website yourself, through a search rather than the link on the certificate, and verify there.
7.The laboratory cannot be found
The certificate names a laboratory, but you cannot find a website, an address or any independent mention of it. The WHO model certificate expects the name and address of the issuing laboratory. In the Philippines, RA 10657 Section 35 allows only firms holding a valid certificate of authority from the Board of Chemistry to operate a chemical laboratory. A laboratory that exists only on the certificate cannot be asked anything.
8.Purity with no method
A purity percentage appears with no method beside it, no chromatogram and no acceptance criterion. Purity depends on how it was measured: the column, the detector and the conditions decide which impurities are separated and seen. The WHO model certificate expects a reference to the test procedure used for each result, and ICH Q2(R2) treats purity tests as needing their own validation. A bare percentage cannot be checked.
9.No identity result
The certificate reports purity, and perhaps amount, but never confirms which molecule was measured. HPLC purity tells you how much of the main peak there was, not what that peak is. A vial could hold a different peptide at high purity and still produce a convincing purity figure. Identity, usually by mass spectrometry with expected and observed masses, is the first result to look for.
10.A mass that does not fit the compound
The identity section reports a mass, but it does not match the published molecular weight of the labelled compound, or it matches a different compound. Large peptides often appear as ions carrying several charges, so a raw peak can sit at a fraction of the full mass; a good report says so or converts it. If the stated expected mass itself differs from the compound's public reference, such as its PubChem record, question the whole identity result.
11.Dates out of order
A sample has to be received before it is analysed, and analysed before the report is issued. A certificate where the analysis date comes before the receipt date, or the issue date before the analysis, has an error at best. Also compare the dates with your batch: a certificate dated before the batch could have been made cannot describe it. Old certificates are often reused for new stock.
12.Fonts or alignment change in key fields
The batch code, date or result is in a slightly different font, size, weight or colour from the text around it, or sits a little off the line. Those are the fields someone would change to reuse a certificate, and edits often leave this kind of trace. It is not proof on its own, since templates vary, but it is a reason to verify the certificate directly with the laboratory before relying on it.
13.Signature with no licence number
The certificate is signed, but the signer has no printed name or no registration number. In the Philippines, RA 10657 Section 40 says a document related to the practice of chemistry is official or admissible for legal purposes only if signed by a registered chemist with the registration number affixed. With a name and number you can check the PRC online verification; without them you cannot.
14.Results to too many decimal places
A purity quoted to four decimal places looks precise, but precision on paper is not precision in the measurement. For impurities, ICH Q3A(R2) asks for results to be reported to two decimal places below 1.0% and one decimal place at and above it, and notes that decimal places do not necessarily reflect a procedure's precision. Long strings of decimals suggest a number copied from software output, or invented, rather than reported with judgement.
15.Units missing
A result is given as a bare number with no unit, so you cannot tell whether it means milligrams, a percentage of the label claim or something else. The WHO model certificate expects numerical results with a comparison against stated acceptance criteria, which only works when units are clear. Amount should be in milligrams per vial, purity as a percentage of peak area, and each with its method.