Analytical services · San Diego
Identity, purity, content and safety for peptide injectables, from a sterile injectable manufacturing site in San Diego.
We test peptide injectable products and issue a certificate of analysis against your specification.
The panels are built around what a peptide actually needs: the solvents your synthesis really uses, the elements a parenteral really has to clear, and identity confirmed by mass rather than by retention time alone.
What we test
Every package is priced per lot and issued as a certificate of analysis against your specification. Tell us your product and batch size and we will scope it.
Identity and quality screening for research-grade material
Our standard injectable release package
Everything in Verify, run across multiple vials for conformity, plus:
Full process panel with a documentation package
Everything in Release, plus:
Individual tests are available on their own or alongside a package. Ask us for the full test list.
Tell us your product and batch size and we will scope it.
Request a quoteBuilt for peptides
A testing panel is only as good as its analyte list. Three places where a general-purpose panel falls short of what a peptide injectable needs.
01 · Solvents
Panels adapted from other industries screen for hydrocarbon gases that have no role in solid-phase peptide synthesis, and leave out the solvents that do. Our peptide-relevant panel covers the USP <467> Class 1 and Class 2 analytes that can plausibly be present, and adds the ones that dominate peptide manufacture and purification.
DMF is a Class 2 solvent, a reproductive toxicant, and the residual most likely to be present in an Fmoc-synthesised peptide. If your current panel does not include it, it is not testing your process.
02 · Elements
For a parenteral product, ICH Q3D requires Class 1 and Class 2A as a minimum. Our standard panel covers all seven by ICP-MS, USP <233>.
Nickel is the one most often missing and the one worth having — a plausible leachable from stainless-steel process contact, with a low parenteral limit and a known sensitisation risk. Class 3 elements are available on request.
03 · Identity
A retention time tells you a peak elutes where your standard elutes. It does not distinguish your peptide from a deletion or substitution analogue that co-elutes with it, and in solid-phase synthesis the most common impurities are the ones that look most like the product.
We confirm identity by LC-MS against the theoretical mass of your sequence and report both values on the certificate, so the identity claim is evidenced rather than asserted.
Real HTML tables, so the chapter numbers and limits stay searchable.
| Solvent | Where it comes from | USP <467> limit |
|---|---|---|
| N,N-Dimethylformamide | Principal coupling solvent | 880 ppm |
| N-Methylpyrrolidone | Coupling solvent | 530 ppm |
| Acetonitrile | Purification mobile phase | 410 ppm |
| Diethyl ether / MTBE | Precipitation, trituration | 5000 ppm |
| Dimethyl sulfoxide | Solubilising co-solvent | 5000 ppm |
| Piperidine | Fmoc deprotection | In-house limit |
| Trifluoroacetic acid | Cleavage and purification | In-house limit |
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| Class | Elements | Parenteral limit |
|---|---|---|
| Class 1 | Cadmium, lead, arsenic, mercury | 2 / 5 / 15 / 3 µg per day |
| Class 2A | Cobalt, vanadium, nickel | 5 / 10 / 20 µg per day |
Scroll sideways to see the full table →
Panels matched to your synthesis route.
Request a quoteProcess-qualification program
Residual solvents and elemental impurities are determined by your synthesis route, solvents, equipment and starting-material supplier. None of those change from lot to lot. The standard pharmaceutical approach, consistent with ICH Q6A reduced-testing principles, is to qualify the process and then verify periodically.
Schematic · every lot still receives the full release panel
| Step | What happens |
|---|---|
| Qualify | Full peptide-relevant solvent panel, TFA and ICH Q3D elemental panel on the first three consecutive lots of a given active, source and process |
| Verify | Thereafter one lot in ten, and on any change of route, solvent, supplier or equipment |
| Revert | Any out-of-trend result returns that product to every-lot testing until three consecutive lots pass |
Scroll sideways to see the full table →
Every lot still receives the full release panel. What changes is how often the process-related tests repeat — a stronger analytical package at a lower cost per lot. Available to clients running more than ten lots a month.
Working with us
Tell us your product, batch size and what you need tested. We send a submission form and a quotation.
Send vials in original sealed containers, marked with lot number, product name, label strength and storage condition. Cold chain ships with a temperature monitor.
Results are reported against your specification, or against ours if you do not have one, and the certificate states the basis.
Vial counts depend on the package and on your batch size. The USP <71> sterility sample plan is what drives the count: the compendial method sets the number of containers against batch size, and method suitability consumes further units. Smaller batches need proportionally fewer vials. Tell us your batch size and we will scale the plan to it.
Where the active has no compendial or commercial reference standard, supply a characterised standard with its certificate. Content is reported against it, and the certificate states the basis.
Ready to scope your lot?
Request a quoteFAQ
Straight answers on what goes on a peptide certificate, which solvents and elements matter, and how identity is confirmed.
Where commonly requested peptides and compounding substances currently stand with FDA, and on what basis.
Peptide compounding statusA release certificate for a peptide injectable typically covers appearance, identity, chromatographic purity with the chromatogram, assay and content per active, solubility, water content, pH, visible particulates, bacterial endotoxins and sterility. Process-related tests — residual solvents, trifluoroacetic acid and elemental impurities — are usually run on a qualification and periodic-verification basis rather than on every lot.
The ones solid-phase peptide synthesis actually uses: DMF, NMP, acetonitrile, diethyl ether or MTBE, dimethyl sulfoxide, piperidine and trifluoroacetic acid. DMF matters most — it is a USP <467> Class 2 solvent limited to 880 ppm and the residual most likely to be present in an Fmoc-synthesised peptide. Panels adapted from other industries often screen for hydrocarbon gases instead and miss it entirely.
Not for a parenteral product. ICH Q3D requires Class 1 — cadmium, lead, arsenic and mercury — plus Class 2A — cobalt, vanadium and nickel — as a minimum. A four- or five-element screen leaves out nickel, which is a plausible leachable from stainless-steel process contact and carries a low parenteral limit.
Retention-time correspondence against a reference standard establishes that a peak elutes where it should. Confirming identity by mass, using LC-MS against the theoretical mass of the sequence, distinguishes the product from deletion and substitution analogues that co-elute with it. We report both.
It depends on the package and on your batch size. Sterility testing to USP <71> drives the count, because the compendial method sets the number of containers against batch size. Packages without a sterility test need far fewer. Tell us your batch size and we will scale the plan.
Yes. We test peptide injectable products for research-use-only companies and for 503A compounding pharmacies.
Supply a characterised standard with its certificate. Content is reported against it and the certificate states the basis.
San Diego, California. For most West Coast and Southwest clients that is one day of ground transit each way.
Request a quote
We will scope it and send a quotation.
