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Determinations are grouped by the question they answer. Every certificate lists only the determinations performed; anything else is reported as not tested.
Establishing that the material in the container is the substance it is described as, and describing what else is present at a compositional level.
The sample is chromatographically separated and the principal component is measured by mass spectrometry. The observed mass is compared against the theoretical mass for the declared structure, with adduct and charge-state assignment recorded. Reported as conforms or does not conform, with the observed value included.
Spectroscopic data can be acquired to support an identity assignment where mass alone is ambiguous — for example distinguishing isomers or confirming a salt form. Interpretation is reported descriptively; spectra references are retained with the raw data.
Enzymatic digestion followed by chromatographic separation and mass detection, with fragment coverage reported. Used when identity at the sequence level, rather than intact mass, is the question being asked.
For multi-component preparations each declared active is treated as a separate analyte with its own label claim and measured content row on the certificate.
Purity and content answer different questions. Purity describes the proportion of the chromatographic profile attributable to the main peak; content describes how much of the substance is actually present in the container.
Reversed-phase separation with diode-array detection, reported as percentage of total peak area at a stated wavelength. Individual and total related-substance results can be tabulated where the scope calls for it. Purity by area percent is not a mass balance and is reported as such.
Measured against a characterised reference standard with a documented calibration, reported in the unit agreed at scoping — percentage of label claim, mass per container, or concentration. The reference standard identifier is recorded on the certificate.
Determined volumetrically or coulometrically depending on expected level. Relevant for lyophilised material, where water content affects both stated mass and stability behaviour.
Determination of the associated acid content, such as acetate or trifluoroacetate, which is often a meaningful fraction of the total mass of a peptide salt.
Size-exclusion separation reporting high-molecular-weight species and fragments as a percentage of total area.
Determinations aimed at what a process or a container leaves behind rather than at the substance itself.
Volatile process solvents are determined from the headspace above the prepared sample and reported per solvent against the agreed limit. Solvents outside the agreed target list are not reported unless the panel is extended.
Digestion followed by elemental determination for a defined element list, typically covering catalyst residues and common container-derived metals. The reported element list is stated explicitly on the certificate.
Microbiological determinations are performed within a defined scope and are always reported alongside the method basis used.
Kinetic determination reported in endotoxin units per milligram or per container, with sample dilution and inhibition/enhancement handling recorded.
Total aerobic microbial count and total yeast and mould count reported as colony-forming units against the stated sample quantity.
Performed on request within agreed scope. Sample quantity requirements are significant and are confirmed before the sample is shipped.
Programmes that run over time, or work aimed at the analytical procedure itself rather than at a single lot.
Scheduled testing of stored material under agreed conditions, with each pull point issued as its own certificate and cross-referenced to the programme.
Controlled stress of the material to establish whether the chromatographic method separates degradation products from the main peak.
Development of a fit-for-purpose procedure, or transfer of an existing client procedure into the laboratory, documented as a report rather than as a certificate of analysis.
Not sure which determinations you need? Describe the material and the decision you are trying to make, and we will propose a scope before any work starts.