Source of Peptide stability table

{{Infobox tool | name = Peptide stability table | subtitle = Interactive reference tool | image = cold-chain.svg | caption = Temperature exposure accumulates along the chain; a stability figure describes one segment of it. | Rows = 28 compounds | Columns = Lyophilised and reconstituted storage, diluent, notes <!-- Caveats --> | Comparability = Low — conditions and assays differ by source | Basis = Manufacturer labelling where available, otherwise published stability studies | Not covered = Sterility, endotoxin, container-closure integrity }} {{primarysources|date=September 2025|talk=Sourcing of the reconstituted-stability column}} The '''peptide stability table''' collects reported storage conditions and stability intervals for compounds covered on this wiki. It is a navigational and comparative aid rather than a source in its own right: every figure in it is attributable to labelling or to a published study, and the two are not equivalent evidence. Stability is a property of a '''formulation in a container under conditions''', not of a molecule. The same peptide may carry a 36-month shelf life as a manufactured product and no meaningful stability claim at all as a lyophilised research powder in an unspecified vial, because nobody has run the study.{{r|ich}} Where the table records a figure for a research compound, that figure is almost always extrapolated from a related product or from a small published study, and the notes column says so. {{warn|Compounds distributed for research are not approved for human use, and no stability figure in this table implies that any material is fit for any purpose. Sterility and endotoxin content are not stability properties and are not covered here.}} == The table == Filter by compound name, or by storage class. Sorting is available on every column. == How to read the columns == ; Lyophilised : Conditions and interval reported for the dry solid in its sealed container. A lyophilised peptide is far more stable than the same peptide in solution, because the degradation pathways that matter — [[Deamidation|deamidation]], [[Methionine oxidation|oxidation]] and [[Peptide aggregation|aggregation]] — all require water or mobility.{{r|manning}} ; Reconstituted : Conditions and interval after dissolution. This is the column with the weakest sourcing across the table, and the one carrying the maintenance banner: for approved products it comes from labelling, and for research compounds it is usually an extrapolation. ; Diluent : What the figure applies to. [[Bacteriostatic water|Bacteriostatic water]] and [[Sterile water for injection|unpreserved water]] are not interchangeable for the purpose of a storage interval, because the interval for a multi-puncture container depends on the preservative. ; Light : Whether photodegradation is reported as significant. Tryptophan- and tyrosine-containing sequences are the usual concern. ; Basis : Whether the row rests on manufacturer labelling, a published stability study, or an extrapolation. Rows marked ''extrapolated'' should not be cited as evidence about the compound named. {{note|An interval is not a cliff. A 28-day figure means the formulation was shown to remain within specification for 28 days under the stated conditions; it does not mean the material is inert on day 27 and unusable on day 29, nor that it was ever tested on day 40.}} == Why cross-source comparison is unsafe == Four differences between sources make two stability figures incomparable even when both are honestly reported. '''The specification differs.''' "Stable for 28 days" means "remained within the specification" and specifications differ. A limit of 95% of label potency and a limit of 90% produce different intervals from identical data. '''The assay differs.''' A stability-indicating [[High-performance liquid chromatography|HPLC]] method that resolves the principal degradant reports loss that a method which co-elutes it does not. [[Analytical method validation|Method validation]] is what establishes that a method is stability-indicating, and research-compound figures rarely state whether it was.{{r|ich}} '''The container differs.''' Adsorption to glass, extractables from a stopper, and headspace oxygen all affect degradation rate. A figure obtained in a Type I glass vial with a coated stopper does not transfer to an uncoated one. '''The temperature history differs.''' A nominal 2–8 °C figure assumes 2–8 °C throughout. Real distribution includes [[Temperature excursion|excursions]], and the mean kinetic temperature of a shipment can exceed its nominal condition substantially.{{r|ich}} {{figure|cold-chain|Nominal storage conditions describe one segment of a chain in which exposure accumulates.}} == What this table does not tell you == It does not tell a reader whether a specific vial is sound. Stability data describes a formulation under conditions; it says nothing about a particular container that has been through an unknown distribution history. Nor does it address: * '''sterility''', which is a property of the process and container-closure integrity, tested under [[USP General Chapter 71|USP <71>]] rather than by a stability study;{{r|usp71b}} storage and packaging requirements are set out separately again;{{r|usp659}} * '''endotoxin''', which does not decrease on storage and is tested under [[USP General Chapter 85|USP <85>]]; * '''identity''', which is what [[Mass spectrometry|mass spectrometry]] establishes and no stability figure implies; * '''the label claim''', which is a [[Peptide content|mass-balance]] question. A compound that is stable, sterile and endotoxin-free may still be the wrong compound. == References == {{reflist}} <ref name="ich">International Council for Harmonisation, ''Q1A(R2): Stability Testing of New Drug Substances and Products'' (2003).</ref> <ref name="manning">Manning MC, Chou DK, Murphy BM, Payne RW, Katayama DS. "Stability of protein pharmaceuticals: an update." ''Pharmaceutical Research'' 27(4):544–575 (2010). DOI:10.1007/s11095-009-0045-6. PMID 20143256.</ref> <ref name="usp659">United States Pharmacopeia, General Chapter <659>, "Packaging and Storage Requirements". USP–NF, current revision.</ref> <ref name="usp71b">United States Pharmacopeia, General Chapter <71>, "Sterility Tests". USP–NF, current revision.</ref> == Further reading == * Wang W. "Lyophilization and development of solid protein pharmaceuticals." ''International Journal of Pharmaceutics'' 203(1–2):1–60 (2000). == See also == * [[Cold chain]] * [[Temperature excursion]] * [[Lyophilisation]] * [[Beyond-use date]] * [[Peptide aggregation]] * [[Deamidation]] {{DEFAULTSORT:Peptide stability table}} [[Category:Interactive reference tools]] [[Category:Cold chain and stability]] [[Category:Preparation and handling]] [[Category:Peptide degradation]]