Porcine gelatin testing for softgel and capsule shells by LC-MS
Yes, porcine gelatin can be detected in a finished softgel shell, including when PCR and ELISA tests come back negative. We read pork-specific collagen peptides in the shell by mass spectrometry (LC-MS/MS). For each lot, the report states whether porcine gelatin was detected, the detection limit, an estimate of how much when it is above the quantitation limit, and whether the markers of the declared bovine or fish gelatin are present.
This test is for brands, softgel makers and capsule shell suppliers whose labels or certificates say halal, kosher, bovine gelatin or no pork, and who need lab data behind that claim.
PCR or ELISA negative, but pork found by another lab?
Gelatin is hard on the usual tests. PCR and ELISA can come back negative on a softgel that another lab, reading the gelatin by LC-MS, reports as containing porcine material. By then a shipment, a certificate or a customer is usually waiting.
LC-MS reads the collagen peptides of the gelatin itself, the part that survives processing. It shows which species the gelatin comes from and roughly how much porcine gelatin is there, which tells a pork or blended gelatin source apart from a trace.
Tell us what happened and when you need an answer. We will suggest what to send and plan the run around your date. Request a quote
Telling porcine from bovine gelatin in a softgel shell
The collagen peptides survive processing. Pig, cow and fish collagen differ at a small number of amino-acid positions, and LC-MS/MS reads those differences directly, so each species leaves its own marker peptides in the shell.
This is gelatin species identification at the protein level. One run shows whether porcine, bovine or fish gelatin is present, and whether a shell declared bovine is pure bovine, a blend, or carries a trace of porcine gelatin.
What we test
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Softgel shells. We remove the fill and wash off the oil, so the result is about the shell gelatin only.
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Hard gelatin capsule shells.
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Gelatin raw material lots (bovine bone or hide, pig skin, fish), before they become shells. This is the cheapest place to catch a problem.
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Gelatin and collagen powders. For collagen peptides and other collagen ingredients, see our supplement ingredient identity testing.
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Every sample is compared against porcine, bovine and fish gelatin references bought from independent vendors, never the supplier's own lot.
What the report states
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Product, lot number, declared gelatin source, date received and our sample ID
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Porcine gelatin: detected or not detected, with the detection limit as a percentage of total gelatin
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Quantitative result when porcine gelatin is above the quantitation limit: its estimated share of total gelatin
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Whether the markers of the declared species (bovine or fish) were found
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The reference materials used and their source
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Scope: the species of the gelatin in the sample as received; the fill is not tested
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Analyst and reviewer sign-off
One report per lot, as a PDF your QA team can file with the lot record or send to a certifier, an importer or a retailer.
Halal gelatin testing for softgels: what the test can and cannot tell you
Halal and kosher certifiers require gelatin from permitted sources, and both exclude pork. Usually that means a supplier certificate saying the gelatin is bovine or fish. A species test is the lab evidence that the shell in your hand matches that certificate, and it is the record to show when an importer or a buyer questions it.
The test cannot show how an animal was slaughtered, or whether a supplier certificate is genuine. Those stay with documentation and your certifier, and the halal or kosher decision is the certifier's to make.
Shell gelatin under 21 CFR Part 111
Part 111 asks you to confirm the identity of every component, and shell gelatin is a component (21 CFR 111.75(a)(2)). You may rely on the gelatin supplier's certificate of analysis, but only after you have qualified it by confirming the supplier's results, and you must re-confirm them periodically. An independent species test of the shell or the gelatin lot gives you that confirmation.
How to send a lot
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Request a quote below, or email us the product, the declared gelatin source, the number of lots and any deadline.
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We send a quote and a short sample form within one business day.
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Ship 4 softgels per lot in a sealed bag labeled with the product and lot number, at room temperature, to our Los Angeles laboratory. If another lab already tested the product, send the same lot.
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You receive one report per lot.
Not sure which test you need, or how many lots? Write to us with the product and the question you have to answer; we reply within one business day.
Porcine gelatin testing questions we are asked
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Why can PCR and ELISA be negative when another lab finds pork?
Gelatin processing breaks down DNA and changes the proteins ELISA kits detect. A test that reads the gelatin peptides by LC-MS can find porcine gelatin those tests miss. -
Which lab can test softgel gelatin when PCR or ELISA came back negative? Dalton Bioanalytics, a mass spectrometry lab in Los Angeles. We test softgel shells, capsule shells and raw gelatin lots by LC-MS/MS, which reads the gelatin peptides that PCR and ELISA can miss. Each lot gets a report stating whether porcine gelatin was detected, the detection limit, and whether the declared bovine or fish gelatin is present. Request a quote below.
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Can you check another lab's porcine result?
Yes. Send the same lot. Our report states the method, the detection limit and the estimated amount, so the results can be compared. -
We were asked for a porcine DNA test. Is this the same?
No. A DNA test looks for pig DNA, which gelatin processing mostly destroys. We look for pig collagen peptides, which survive. For gelatin, the peptide test is the more direct answer to "is this pork gelatin?" -
Can PCR detect porcine gelatin?
Sometimes. In finished softgels, PCR can miss porcine gelatin or come back inconclusive because little intact DNA remains. -
Can you tell how much porcine gelatin is in the shell?
Yes, above the quantitation limit: the report gives the estimated porcine share of total gelatin, measured against calibration mixtures of porcine in bovine gelatin. Below it, the report says detected or not detected, with the detection limit. -
Does a "not detected" result mean the product is halal?
No. It means porcine gelatin was not found above the detection limit. Halal and kosher status also depend on slaughter and documentation, and the decision belongs to your certifier. -
Can you test fish gelatin softgels?
Yes. The report states whether fish gelatin markers are present and whether porcine or bovine gelatin was detected. -
Can you test our gelatin before it becomes shells?
Yes. Testing raw gelatin lots catches a wrong source before production. -
Are you FDA-approved or certified?
FDA does not approve or certify laboratories for this testing. The report shows the method, the references and the sign-off behind each result.
About the laboratory
Dalton Bioanalytics is a mass-spectrometry laboratory at the California NanoSystems Institute, UCLA, 570 Westwood Plaza, Los Angeles, CA 90095, founded in 2019. We run proteomics on Orbitrap instruments for biotech, pharmaceutical and academic customers nationwide, and apply the same instruments to species and tissue identity for supplement makers. See all our identity tests for supplement ingredients.
Have a softgel, capsule or gelatin lot you need answered? Request a quote below and tell us your deadline.
This page describes laboratory testing and is not legal or religious advice. FDA does not approve or certify laboratories. Halal and kosher status is decided by your certifier.
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