Working definitions for the terminology used above. Each entry has its own anchor, so a definition can be linked to directly.
- Certificate of analysis (COA)
- The document a laboratory issues to report the analytical results obtained for one specific batch of material, naming the compound, the lot, the methods, the figures and the dates.
- Lot number
- The identifier that connects a document to a physical vial. Without a lot number matching the label, a certificate describes some material but not necessarily the material in hand.
- Batch
- Material produced in a single campaign, purified together and pooled before fill. Because the batch is homogenised, one analytical sample can reasonably represent every vial carrying that lot number.
- Assay / purity result
- The quantitative composition figure, normally chromatographic purity by RP-HPLC: main peak area as a percentage of total integrated peak area under the stated conditions.
- Identity confirmation
- A separate determination — usually mass spectrometry — establishing that the main peak is the intended sequence rather than a cleanly chromatographing analogue.
- Theoretical mass
- The molecular mass calculated from the intended sequence, against which the observed mass on the report is compared.
- Observed mass
- The molecular mass actually measured by the mass spectrometer. Agreement with the theoretical mass within instrument tolerance is what supports the identity claim.
- Method
- The stated analytical conditions — column chemistry, gradient, run time, detection wavelength. Two purity figures produced under different methods are not directly comparable.
- Analysis date vs report date
- The analysis date is when the measurement was made; the report date is when the document was issued. Both indicate how current the data is relative to the material.
- Analysing laboratory
- The party that performed the measurement. Naming it is what makes a figure accountable and, where the laboratory is unaffiliated, independent.
- Net peptide content
- How much of the lyophilised cake is peptide by mass, as opposed to counter-ion, residual water or solvent. It is a separate determination from chromatographic purity.
- Superseded certificate
- An earlier lot's document retained after a newer lot is released, so material already in a freezer can still be read against the record that applies to it.