Provenance
From specification to release
Every substance in the catalogue is released against a written specification verified by HPLC, mass spectrometry and the supporting analytical methods below. Release documentation is archived per lot.
Sequence specification
Each peptide sequence is defined against a written specification, including amino acid composition, sequence, and required purity. The specification is the contract between the synthesis facility and the release laboratory.
cGMP-audited synthesis
Synthesis is carried out in European facilities operating under cGMP-audited conditions, with validated standard operating procedures, full documentation, and audit trails. Every batch is traceable to its synthesis record.
HPLC purification
Reverse-phase high-performance liquid chromatography separates the target peptide from truncated sequences, oxidation by-products and residual reagents. Purity is targeted against the written specification.
Fill and primary packaging
Purified substance is filled into sealed primary containers with lot labels, tamper-evident seals and lot documentation. Primary packaging is designed for laboratory handling, not for administration to humans or animals.
Characterisation and release
Identity is confirmed by mass spectrometry. Purity is measured by analytical HPLC. Residual water is measured by Karl-Fischer titration. Endotoxin is measured by LAL assay. Results are recorded on the lot release record.
Safety Data Sheet
A Safety Data Sheet compiled under REACH Annex II is available for every substance. Lot release records and the Safety Data Sheet are retained for ten years.
Release documentation is not a marketing claim. It is the condition on which a substance becomes a reference standard. The substance must be what the specification says it is, at the purity the specification requires, every lot.
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