Document registry — page 8
Every document the Institute has published, 1,621 in total, with its identifier, type, certainty rating and review date.
Documents
-
The counter-ion most commonly introduced by reverse-phase purification with trifluoroacetic acid. Quantified by ion chromatography or fluorine nuclear magnetic…
30 Jul 2026 -
The reference method for water content, based on the stoichiometric reaction of water with iodine and sulfur dioxide. The only water determination the Institute accepts…
30 Jul 2026 -
The mass fraction of a lyophilisate that is water. Substantial for a hygroscopic peptide and a direct subtraction from delivered peptide mass.
30 Jul 2026 -
Determination of mass-to-charge ratio, used to confirm identity. For a peptide, deconvolution of the multiply charged envelope should return an average mass within a…
30 Jul 2026 -
The mass calculated using the most abundant isotope of each element. Requires high resolving power to determine for a peptide of several kilodaltons, and is not…
30 Jul 2026 -
The mass calculated using isotope-averaged atomic weights, and the value returned by deconvolution of an electrospray charge envelope at moderate resolution.
30 Jul 2026 -
A second analytical method resting on a different physical principle from the first. Identity confirmed by two orthogonal methods is materially stronger than identity…
30 Jul 2026 -
Confirmation that the material is the substance claimed. Retention-time correspondence alone is weak evidence of identity; mass-spectrometric confirmation of the…
30 Jul 2026 -
Enzymatic digestion followed by chromatographic and mass-spectrometric analysis of the resulting fragments, used to confirm sequence. Rarely performed on research-supply…
30 Jul 2026 -
Impurities structurally related to the target peptide, arising from synthesis or degradation. Reported by name and retention time on a complete certificate and as a…
30 Jul 2026 -
An impurity lacking one or more residues, arising from incomplete coupling during synthesis. Often close-eluting and detectable only by mass spectrometry.
30 Jul 2026 -
Conversion of asparagine or glutamine to the corresponding acid, adding one dalton and altering charge. A principal storage-related degradation route for peptides in…
30 Jul 2026 -
Conversion of aspartate to isoaspartate through a succinimide intermediate, producing a species of identical mass and different retention. Undetectable by mass alone.
30 Jul 2026 -
Addition of oxygen to methionine, tryptophan or cysteine, adding sixteen daltons. Accelerated by peroxide, light and metal ions.
30 Jul 2026 -
Association of peptide molecules into higher-order species, driven by agitation, freeze–thaw cycling and proximity to the isoelectric point. Not detected by a…
30 Jul 2026 -
Separation by hydrodynamic radius, the standard method for aggregate determination. Reported on no certificate in the Institute’s sampled set.
30 Jul 2026 -
Lipopolysaccharide from Gram-negative bacterial cell walls, pyrogenic on parenteral administration. Determined by a lysate-based or recombinant assay against a dose- and…
30 Jul 2026 -
The absence of viable microorganisms, demonstrated by a compendial test on the finished presentation. Distinct from endotoxin content, which persists after sterilisation.
30 Jul 2026 -
The proportion of residues in the intended stereochemical configuration. Racemisation during synthesis produces species of identical mass and identical reverse-phase…
30 Jul 2026 -
The lowest concentration at which a determination can be made with stated precision and accuracy. An impurity below the limit is not absent; it is unquantified.
30 Jul 2026 -
The lowest concentration at which the presence of a species can be distinguished from noise. Lower than the limit of quantitation and not a basis for a numerical result.
30 Jul 2026 -
A characterised material with an assigned content value against which a determination is made. A result obtained without a named standard reports an area percentage…
30 Jul 2026 -
Repeated freezing and thawing of a solution. Concentrates solutes in the shrinking liquid fraction, drives pH excursion as buffer components crystallise differentially…
30 Jul 2026 -
The time a reconstituted preparation may be stored and used, supported by stability-indicating data on that presentation. The Institute publishes no in-use claim for any…
30 Jul 2026 -
Loss of peptide to container and syringe surfaces, material at low concentration in the absence of a surfactant. A source of content loss that no certificate reports.
30 Jul 2026 -
The document accompanying a batch, reporting the determinations made and the results obtained. Its value depends entirely on which fields it carries and whether the…
30 Jul 2026 -
The Institute’s specification of the fields a certificate must carry for a purity or content claim to be interpretable. Fields are classified as critical or recommended…
30 Jul 2026 -
The linkage between a certificate and the specific batch supplied, by batch identifier and date. A certificate that cannot be linked to the material in hand is a…
30 Jul 2026 -
Analysis performed by a laboratory independent of the supplier. Stronger evidence than a supplier-issued certificate, and weaker than analysis of an independently…
30 Jul 2026 -
The record of where an analysed sample came from and who selected it. A supplier-selected sample and an independently purchased one are different classes of evidence and…
30 Jul 2026 -
In an Institute supplier dossier, a determination supported by documentation the Institute has examined. Verification is of the documentation and never of the product…
30 Jul 2026 -
In an Institute supplier dossier, a claim for which the Institute has looked for supporting documentation and not found it. Distinct from not assessed.
30 Jul 2026 -
In an Institute supplier dossier, an attribute the Institute did not examine. Carries no implication about the attribute and is recorded so that a reader can distinguish…
30 Jul 2026 -
A supply designation indicating that material is not manufactured under a marketing authorisation and is not approved for human or veterinary use in any jurisdiction. A…
30 Jul 2026 -
A regulated system of controls over manufacture, in which a claim of compliance is meaningful only where an inspecting authority is named. An unverified compliance claim…
30 Jul 2026 -
The international standard for the competence of testing laboratories. Accreditation is granted for named tests within a defined scope; a laboratory accredited for one…
30 Jul 2026 -
Permission from a competent authority to place a medicine on the market for a stated indication. Specific to product, indication, presentation and jurisdiction.
30 Jul 2026 -
Holding no marketing authorisation for the use in question. A compound may be approved in one indication and unapproved in another, and approved in one jurisdiction and…
30 Jul 2026 -
Use of an authorised product outside the terms of its authorisation. A regulated product used outside its licence, and distinct from an unapproved product, though the…
30 Jul 2026 -
The most prominent warning a competent authority can require in product information. Signals regulatory concern; does not itself establish that the risk is realised in…
30 Jul 2026
page 8 of 41