Services

The full release panel.

No single measurement defines a material. Identity, purity and contamination are established by combining techniques whose principles do not overlap — orthogonal methods, one conclusion. Commission a single determination or a complete batch-release dossier.

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Identity confirmation

Primary identity by high-resolution mass spectrometry, with orthogonal confirmation against a traceable reference standard. Molecular weight and characteristic fragmentation are recorded.

LC-MS · HRMS

Chromatographic purity

The main component is resolved from impurities and degradants by reversed-phase HPLC with UV detection. Each related substance is reported by area percent.

RP-HPLC · UV

Quantitative assay

Content of the labelled compound determined against a calibrated reference standard, so a label claim can be checked rather than assumed.

HPLC-UV

Water & residual solvents

Residual water by Karl Fischer titration and process solvents by headspace GC — the values that quietly shift mass balance and true peptide content.

Karl Fischer · GC

Elemental impurities

Catalytic residues and heavy metals screened element by element and reported to ppb, against pharmacopeial limits where applicable.

ICP-MS · USP <232/233>

Endotoxin & sterility

Bacterial endotoxin by LAL and recoverable microbial growth by membrane filtration, for material presented in an injectable or reconstituted format.

LAL · USP <71>

Not sure which determinations you need?

Tell us the compound and what you need to demonstrate. We'll scope the right panel and issue a written quote before any work begins.

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