Methodological standards in the registry

Determination of aggregate content by size-exclusion chromatography

Freeze–thaw and in-use stability assessment of reconstituted peptide solutions

Determination of peptide content and its distinction from chromatographic purity

Bacterial endotoxin determination in peptide preparations intended for parenteral use

Certificate-of-analysis minimum data standard for synthetic peptide preparations

Purity determination for peptides not retained by conventional reverse-phase chromatography

Assessment of appearance, cake integrity and reconstitution behaviour

Development and validation of a stability-indicating method for peptide preparations

Identification and quantification of counter-ions in synthetic peptide salts

Photostability assessment of light-sensitive peptides

Sub-visible particulate matter in reconstituted peptide solutions

Determination of water content in lyophilised peptides by coulometric Karl Fischer titration

Residual solvent determination by static headspace gas chromatography

Related-substances profiling and the detection of isobaric impurities

Protocol for independent third-party verification of a supplied preparation

Sterility testing of peptide preparations presented in sealed vials

Determination of chromatographic purity of synthetic peptides by reverse-phase high-performance liquid chromatography

Confirmation of peptide identity by liquid chromatography–tandem mass spectrometry