Cerebrolysin

1 Identity

Biological extracts and compositionally undefined preparations. the identity being established by that seller's own published identifiers. and "CerebroNeurogen". Cerebrolysin concentrate and "porcine brain peptide preparation"; adjacent names in the same channel — Cerebrolysat and other brain-protein hydrolysates — are not this article and are not distinguishable from it by any assay.

Sequence

No defined sequence, and this record exists to say so precisely. The article is peptide material, but it is not a single defined molecular entity: it is the product of controlled, standardized enzymatic proteolysis of purified porcine brain protein (originator EVER Neuro Pharma GmbH, Austria; development code FPF-1070), supplied as a sterile aqueous solution in sealed ampoules at a declared 215.2 mg of concentrate per mL. The originator declares approximately three-quarters free amino acids and approximately one-quarter peptides below 10 kDa. No individual sequence, no reference standard, no residue string. A certificate that prints a sequence, a single peptide identity or a named "main component" for Cerebrolysin is describing something other than Cerebrolysin.

Molecular formula

Not established, and not establishable. A mixture has no molecular formula. The only honest entry here is the statement that the article is defined by its process, not by a structure.

Average mass

Not established — and this is a stronger statement than "not yet established": the number does not exist anywhere, because the article is not a substance. No reference standard exists in the world to confirm one against. The only quantitative figure the originator publishes, 215.2 mg of concentrate per mL, is a fill concentration and not a molecular mass; a document that carries 215.2 into a molecular-weight field has committed a category error. That fill figure and the pack declarations do corroborate each other: 215.2 mg per mL against 2, 5, 10 and 20 mL gives 430.4, 1076, 2152 and 4304 mg against the declared 430, 1075, 2150 and 4300 mg, consistent to rounding. The only figure that could honestly occupy this field is a molecular-weight-distribution profile by SE-HPLC with a defined acceptance window, obtained from a supplier dossier.

Monoisotopic mass

Not established and not establishable, for the same reason. No monoisotopic mass can be assigned to an undefined mixture, and any single monoisotopic number on a Cerebrolysin certificate is evidence that the certificate was written for a different article.

Salt / variant note

Two articles trade under this one name and they are not the same physical thing. (1) originator finished drug — EVER Neuro Pharma GmbH / EVER Pharma Jena, sterile aqueous solution, 215.2 mg concentrate per mL, glass ampoules of 2 mL (430 mg), 5 mL (1075 mg), 10 mL (2150 mg) and 20 mL (4300 mg), excipients sodium hydroxide and water for injection. (2) peptide-seller article — a 60 mg lyophilized powder vial, declared "manufactured in the USA" and "greater than 98 percent purity", offered by at least seven independent sellers. The 10 mL originator ampoule contains 2,150 mg of solids; the peptide-seller vial contains 60 mg — a roughly 36-fold difference in declared solids, in a different physical form (powder against solution), from a different continent, with no stated source species. Nothing but the name is shared, and because neither article has a molecular identity there is no analytical test that can establish which one is in a given vial. (3) Adjacent named hydrolysates in the same channels — "Cerebrolysat" and other brain-protein hydrolysates, including cattle-derived preparations, and "Cerebrolysin"-branded ampoules from manufacturers other than the originator. Because no assay can distinguish any of these from each other, substitution here is not arithmetically detectable at all, which is the distinguishing feature of panel P7.

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.

Unusually for this catalog, a substantial controlled human trial literature exists: several dozen randomized trials, principally from Europe, the Russian Federation and Asia, including multi-hundred-patient trials in acute ischemic stroke, together with at least two Cochrane systematic reviews (acute ischemic stroke; vascular dementia) and several meta-analyses. This is a description of what has been studied and published, not a statement of what was found, and the reviews' conclusions are not restated here; the reviews themselves record a concentration of trials within a single sponsor-affiliated program, which is a fact about the literature's structure. What does not exist: any FDA-reviewed marketing application, any US pivotal trial, and any published chemical characterization sufficient to write a specification. The evidence page carries roughly 40 references with DOIs and Cochrane review identifiers.

4 Storage & specification

Storage

Supplied as a sterile aqueous solution in sealed glass ampoules, not a powder. The labeled condition is 2 to 8 degrees C, protected from light, do not freeze, with ampoule integrity verified on receipt and any precipitate a rejection condition. A liquid-filled ampoule cannot be handled under the dry-solid conditions that apply to a powder, and the two sets of handling and shipping assumptions are not interchangeable.

Shelf life

Each ampoule is dated by the expiry printed on it by its manufacturer, and stock is rotated first-expiry-first-out against that date. Dating rests on the printed expiry rather than on an interval derived here, because 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 — there is no attribute whose change would constitute degradation, because there is no defined starting attribute. What limits the article in storage is what a panel P7 article can be judged on: ampoule integrity, the absence of precipitate, and the printed expiry.