Reference
Glossary
Analytical and regulatory terminology only. Nothing here describes the effects or uses of any compound.
- Amino acid analysis (AAA)
- A determination that hydrolyses a peptide into its constituent amino acids and quantifies them, used to establish net peptide content and to support composition.
- Bacterial endotoxin test (LAL)
- A test for bacterial endotoxin using limulus amebocyte lysate or a recombinant equivalent, reported against a stated limit.
- Certificate of analysis (COA)
- A document recording the results of specific analytical tests performed on a sample from a specific lot, on a stated date, by a stated laboratory.
- Chain of custody
- The documented record of who held a sample, and under what conditions, between its origin and its analysis.
- Chromatographic purity
- The main peak's share of total detected peak area in a chromatographic run, usually reported as a percentage.
- Counterion
- The ion paired with a charged peptide in its isolated salt form — trifluoroacetate and acetate are common.
- Electrospray ionisation (ESI)
- An ionisation technique that transfers molecules from solution into the gas phase as ions, widely used for peptide mass spectrometry.
- HPLC
- High-performance liquid chromatography: a separation technique that resolves a mixture into components, commonly with UV detection for peptides.
- ISO/IEC 17025
- The international standard for the competence of testing and calibration laboratories, granted by an accreditation body for a defined scope of methods.
- LC-MS
- Liquid chromatography coupled to mass spectrometry: separation followed by mass measurement of the separated components.
- Lot (batch)
- A quantity of material produced under conditions treated as uniform, identified so that test results on a sample can be attributed to the whole quantity.
- Mass confirmation
- Comparison of an observed molecular mass against the mass calculated from a compound's intended structure or sequence.
- Net peptide content
- The proportion of a preparation's mass that is peptide, as distinct from counterion, water and residual salts.
- Research use only (RUO)
- A labelling statement indicating a product is not intended for use in humans. In US regulation the phrase is specifically defined for in vitro diagnostic products.
- Intended use
- The purpose for which a product is represented, assessed from the totality of the evidence about how it is presented and marketed.
- Sterility testing
- A compendial test for the recovery of viable microorganisms from a sample under defined culture conditions.
- Third-party testing
- Analysis performed by a laboratory with no commercial interest in the result, commissioned by and reported to a party independent of the seller.
- Trifluoroacetate (TFA)
- A counterion frequently retained by peptides purified by preparative reversed-phase HPLC using trifluoroacetic acid as a mobile-phase modifier.
