Purity

HPLC (high-performance liquid chromatography)

The sample is separated on a chromatography column and detected by UV absorbance. Purity is the main peak's share of the total peak area.

What it tells you
How much of what the detector sees is the target peptide, as a percentage.
What it does not
It does not confirm what the main peak is (that is identity) or how much peptide is in the vial (that is net content).

Identity

LC-MS (liquid chromatography with mass spectrometry)

The separated sample is passed to a mass spectrometer, which measures the mass of the main component.

What it tells you
Whether the observed mass matches the expected mass of the named peptide.
What it does not
It does not measure purity or quantity, and it does not assess sterility.

Net content

Quantitation against a reference standard

The amount of peptide in the vial is measured against a reference of known concentration.

What it tells you
How many milligrams of peptide the vial holds, compared with the amount on the label.
What it does not
It does not tell you whether the peptide is the right one or how pure it is.

Endotoxin

Bacterial endotoxin test (LAL)

A reagent that reacts to bacterial endotoxins is used to measure how much endotoxin the sample contains.

What it tells you
The endotoxin level, usually in EU per milligram or per vial.
What it does not
It does not detect live microorganisms (that is sterility).

Sterility

Culture in growth media

The sample is placed in growth media and incubated, then checked for microbial growth.

What it tells you
Whether microbial growth was detected in the sample tested.
What it does not
It covers the units sampled. It does not measure endotoxin, and results take about two weeks.

Heavy metals

ICP-MS (inductively coupled plasma mass spectrometry)

The sample is analysed for elemental impurities such as lead, arsenic, cadmium and mercury.

What it tells you
The level of each metal tested, or that it was not detected above the stated limit.
What it does not
It reports only the elements on the panel.

Residual solvents

GC-MS (gas chromatography with mass spectrometry)

Volatile solvents left over from synthesis and purification are separated and measured.

What it tells you
The level of each solvent on the panel, or that it was not detected above the stated limit.
What it does not
It reports only the solvents on the panel.

Water activity

Water activity meter

Measures the free water in a dry powder, on a scale from 0 to 1.

What it tells you
How much water is available in the powder, which bears on its stability in storage.
What it does not
It is not the total water content, and it says nothing about purity or identity.

pH

pH meter

Measures the acidity of the product in solution.

What it tells you
The pH of the solution as tested.
What it does not
It describes the solution only, not the peptide's purity or identity.

Which tests a lot receives is chosen when it is sent for testing. A certificate lists only the tests that were performed on that lot.

Need testing for your lots?

Tell us what you sell and which tests you need.

Contact us