How to Submit Peptides for Third-Party Testing

Most of the questions we get about submissions are about logistics. Where to ship, how much to send, how long it takes. Those matter and they are the easy part.

The decisions that determine what the resulting certificate can honestly claim are made earlier, at your facility, before anything is packed. This is what a submission involves, with those decisions flagged where they occur.

Before anything ships: decide what the certificate is for

A certificate is a narrow document and it should be commissioned with its intended use in mind, because that determines what has to be tested and how the sample is drawn.

Three common intentions, which are not the same job.

Batch release. You want a certificate that describes a specific production run so it can accompany that lot. This requires a defined batch with an identifier and a sample drawn to represent it.

Incoming material qualification. You want to know whether raw material from a supplier is what the supplier said. Same analytical work, different subject, and the certificate attaches to the incoming lot rather than to your finished product.

Investigating a problem. Something looks wrong and you want to know what. This is the one case where a targeted, non-representative sample is the correct choice, because you are not trying to describe a population.

Being explicit about which of these it is prevents the most common documentation error in the category, which is a certificate produced for one purpose being used to support a claim it was never scoped to make.

Define the batch

A representative sample requires something to be representative of, so the batch has to exist as a defined population before sampling begins.

That means a batch identifier, a known unit count, a production date, and boundaries that are real rather than administrative. Material from two separate runs combined under one identifier is not one batch, and a certificate describing it as one will be accurate about the sample and misleading about everything else.

The identifier matters beyond the laboratory, because it is the only thing that ever links the certificate back to physical product. A certificate with no batch identifier cannot be tied to anything, and it will still be circulating unchanged three production runs later. If the units themselves carry no batch marking, nobody downstream can match the document to the vial, including you.

Draw the sample properly

This is the step that decides what the result can be generalized to, and it happens entirely on your side.

The requirements are not complicated.

• Select systematically, not conveniently. Units drawn according to a rule set in advance, not chosen by whoever packed the box. Convenience sampling is where selection bias enters, and it is invisible in the output.
• Span the run. Production is not always homogeneous. Fill weight drifts, lyophilization can vary across a shelf, a blend can separate. Material drawn from across the run detects variation that material from one point cannot.
• Document how you drew it. Which units, from where in the run, on what basis. This is the part of the chain of custody that the laboratory cannot reconstruct afterwards, and it is what makes the sampling defensible later.

Our minimum of 1,000 units per submission exists to make this possible rather than to filter clients. Below that scale a result describes the units tested and cannot honestly be reported as a statement about a production run. The reasoning is set out in full in single vial versus batch representative testing.

Specify the tests

Purity and identity are the standard pairing and they answer different questions, so both should be on the request. Purity by high-performance liquid chromatography quantifies how much of the material is the target compound. Identity by mass spectrometry confirms that the compound is the one named. A result with only one of the two is half an answer, as covered in HPLC versus mass spectrometry.

Two additions are worth considering explicitly, because neither is implied by a purity figure.

Net peptide content measures how much of the lyophilized material is peptide by weight, by amino acid analysis or nitrogen determination. Chromatographic purity does not describe this, because counterion and residual water contribute real mass and no ultraviolet peak. Where dosing accuracy or mass balance matters, request it by name.

An itemized impurity profile reports the significant minor peaks rather than just the main one. It is considerably more informative than a single figure, particularly for comparing runs over time, and it is what tells you whether a synthesis is drifting.

Tell us what the compound is supposed to be, including the sequence where relevant. Reference standards are selected against the claim, and a submission with an ambiguous or proprietary product name and no stated composition slows everything down.

Packaging, labeling and shipping

Once a submission is confirmed we send full shipping, packaging and labeling instructions, and they are worth following exactly because a sample that arrives degraded produces a result about a degraded sample.

The general principles: units should be sealed and intact, labeled so that each one is individually identifiable and traceable to the sampling record, protected against temperature excursion and physical damage in transit, and accompanied by documentation that matches what is physically in the box. A discrepancy between the packing list and the contents has to be resolved before testing begins, which costs days.

We receive samples from clients around the world. International shipping of any material requires the sender to comply with the export requirements of their own jurisdiction and the import requirements of the destination, and that responsibility sits with the sender.

What happens at the laboratory

On arrival the batch is logged, assigned a unique internal identifier and handled under documented chain-of-custody controls. Sample preparation follows method specification, alongside certified reference standards run under the same conditions, which is what anchors retention time and response to a known material rather than to the instrument on that particular day.

Purity is measured by HPLC and identity confirmed by mass spectrometry. Each run is reviewed by an analyst, and every compound is assessed by several members of the scientific team rather than one, so a result reflects a repeatable process rather than a single reading.

The measured result is then recorded to a Certificate of Analysis with a unique verification key and entered in our permanent register.

Current turnaround is 21 days from receipt of samples. Most of that is queue and review rather than instrument time.

What comes back

A Certificate of Analysis stating the compound, the batch identifier, the methods used, the measured purity against the method that produced it, the identity confirmation, the date, and a verification key.

The key resolves on this site to the recorded result and the client the certificate was issued to. That record is permanent and it is the authoritative version if it ever disagrees with a copy of the document.

One consequence of that worth being clear about before you commission anything: we record what we measured. A result is what it is, and a certificate reflects the real measured outcome of the sample submitted. That is the entire value of the arrangement, and it is not a service that can be usefully bought on any other terms.

Using the certificate afterwards

Two habits make a certificate hold up under scrutiny, and both are about scope.

Keep the certificate attached to its batch. It describes that lot. Presenting it alongside later production, without a batch link, is where a genuine document quietly turns into a misleading one.

Let customers verify it themselves and tell them how. A supplier who points a customer at the laboratory's own verification page, rather than hosting a copy of the PDF, is making a claim that survives being checked. Our note on how verification works is written for that audience and can be linked directly.

To discuss a submission, email admin@novagenlaboratories.com.