Endoluten

1 Identity

Biological extract — compositionally undefined peptide-containing preparation of animal pineal gland. Not a single chemical entity and not a synthetic peptide. and peptide complex A-8. Must not be treated as a synonym for epitalon, which is a defined synthetic tetrapeptide listed separately in the catalog.

Sequence

No defined sequence, and there is nothing to state. Endoluten is a trade name for a lyophilized peptide-containing extract of bovine (calf) pineal gland, the preparation described in the Russian literature as epithalamin, prepared by acid-acetone or saline extraction of animal tissue and supplied as a mixture of low-molecular-weight peptides together with residual tissue components in undeclared, lot-variable proportions. There is no sequence to state, no terminus to cap and no counterion to declare, because there is no single molecule to which those properties attach. Retail labeling declares only "peptide complex A-8 (epiphysis peptides)" at 20 mg per two capsules, alongside microcrystalline cellulose, lactose, starch, beet sugar and sugar; no species and no tissue-processing statement appeared on the retail labels examined. If a supplier offers "Endoluten" as a synthetic short peptide, that supplier is offering something other than the named product, and the discrepancy is a disqualifying finding on the supplier, not a question about the lot.

Molecular formula

Not established and not establishable. A molecular formula is a property of a single chemical entity and this article is an unenumerated mixture. No formula is asserted and none can be.

Average mass

Not established, and no molecular weight exists, because the article is not a single molecule. Any supplier stating one has either substituted a defined compound for the extract or invented the figure. The 20 mg on the retail label is a fill weight of the extract, not an assay of any named substance.

Monoisotopic mass

Not established and non-existent, for the same reason. An ESI-MS trace of this article is a distribution characteristic of one production run, not a mass and not an identity. It is admissible only as a batch-to-batch comparator in a characterization report, never on a certificate.

Salt / variant note

Multi-article name, and the substitutions are cheap and routine. (1) The retail capsule extract itself, the labeled article. (2) The injectable bovine pineal extract sold in Russia as epithalamin or Epiphysan, chemically the same undefined class in a different presentation. (3) epitalon substituted for the extract: the synthetic tetrapeptide H-Ala-Glu-Asp-Gly-OH, C14H22N4O9, 390.349 avg / 390.13868 mono. A certificate for "Endoluten" showing a single clean peak at 390 Da contains epitalon and proves substitution rather than identity. (4) A second substitution inside the first: Vesugen, H-Lys-Glu-Asp-OH, C15H26N4O8, 390.393 avg / 390.17506 mono, which is 0.044 Da from epitalon on the average mass and 93 ppm from it monoisotopically, so a lot already substituted with a tetrapeptide can be substituted again with a tripeptide without the nominal mass moving. (5) Cross-species and cross-organ substitution: the whole branded extract range, Testoluten, Vladonix, Thyreogen, Glandokort, Cerluten and the rest, is analytically indistinguishable by any peptide method, and bovine, porcine and ovine source tissue can be separated only by species-specific PCR against a mitochondrial target or by species-specific immunoassay, neither of which is a peptide test.

2 Class & testing panel

Form

Single article

Testing panel

P7 — panel definition

3 Primary sources & evidence

The index reports the design and provenance of the literature, not a conclusion about effect.

Predominantly Russian-language literature on the pineal extract described as epithalamin, largely from the publication network of the Saint Petersburg Institute of Bioregulation and Gerontology, with rodent work and a small number of long-running clinical series; study types are mostly uncontrolled or open-label. No Cochrane review was identified. No ClinicalTrials.gov or EU Clinical Trials Register registration was identified. The controlling limitation, which carries the same weight as the citations: much of the literature indexed under "epithalamin" concerns the extract while much indexed under "epitalon" concerns the synthetic tetrapeptide, and the two bodies of work are routinely merged by sellers. They are different articles, and the merge is a named defect in how this article is marketed. Furthermore, with no reference standard for the extract, no laboratory anywhere can reproduce a reported result on the same material, so the extract literature is not independently checkable even in principle.

4 Storage & specification

Storage

Stored lyophilized in a sealed, light-protected primary container with a desiccant sachet and a tamper-evident closure, at -20 degrees C plus or minus 5 degrees C, protected from moisture. Because the preparation is compositionally undefined, it is held in a physically segregated location away from synthetic API, so that a tissue-derived article and a defined molecule never share a receiving or sampling location.

Shelf life

A retest date is an output of a stability-indicating assay, and no stability-indicating assay can be written for an article of undefined composition, so this article is dated from the manufacturer's declared extraction and packaging date, transcribed onto the lot record at receipt and rotated first-expiry-first-out on that date. The attributes that limit the interval are moisture content of the lyophilized cake, closure integrity, and drift in the batch-to-batch peptide profile held as the lot comparator; the date carried is shortened whenever one of the three moves.