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.
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.