What's on the label is the measured result — net peptide mass, not gross powder weight, plus RP-HPLC purity, on a lot-numbered COA for every batch.
Net peptide mass and RP-HPLC purity — a lot-numbered COA for every batch.
Net peptide mass + HPLC purity, per lot.
PCAC will review 7 peptides for the 503A bulks list, BPC-157, KPV, TB-500, MOTS-c, Emideltide, Semax, Epitalon. Read our briefing →
PCAC will review 7 peptides for the 503A bulks list. Read →
FDA PCAC reviews 7 peptides in July. Read →
Neurotrophic peptide / protein-hydrolysate complex
PeptideXpo buyer fit
This PeptideXpo page is intentionally positioned for distributors, OEM buyers, and procurement teams comparing Cerebrolysin inside a wider peptide catalog. It is not trying to be the deepest single-molecule monograph; the differentiated intent is assortment planning, export-ready documentation, fill-size comparison, and whether this SKU belongs in a broader buyer program.
Overview
Cerebrolysin is a complex neurotrophic preparation derived from enzymatic and proteolytic hydrolysis of purified porcine cerebral cortex proteins. The resulting preparation contains a defined-process mixture of free amino acids and biologically active low-molecular-weight peptides (typically below 10 kDa) that includes fragments with neurotrophin-like activity (CNTF-like, BDNF-like). Cerebrolysin is approved as a prescription neurological biological in multiple jurisdictions including Russia, China, several Eastern European markets, and parts of Southeast Asia, with indications spanning ischemic stroke recovery, traumatic brain injury, Alzheimer's disease, and vascular dementia. As a complex peptide mixture rather than a single defined molecule, Cerebrolysin does not carry a single CAS identifier; its identity is established by composition-fingerprint analysis against a documented reference. PeptideXpo supplies Cerebrolysin only to qualified buyers with appropriate licensing for prescription neurological biological products in their destination jurisdiction. The 60 mg standard vial corresponds to a typical clinical-dose unit. The release packet emphasizes batch-to-batch compositional reproducibility, measured by HPLC fingerprint analysis against a documented reference profile rather than the single-peak HPLC purity metric used for defined synthetic peptides.
Who buys this, and why
Custom-blend buyers are almost always OEM clients building a branded product around a specific ratio of two or more peptides. The development workflow is collaborative: ratio target, analytical method to verify it, stability protocol in the chosen carrier, and packaging selection are all defined in the OEM brief before the first commercial run. Sample-stage volumes are usually 5-10 g of finished blend; commercial MOQ depends on the components.
Primary buyer fit: academic and contract research laboratories.
Specifications
Documentation available on request
Regulatory note
Approved as a prescription neurological biological in several jurisdictions (Russia, China, Eastern Europe, parts of SEA); not approved in US or EU. Supplied only to qualified buyers with appropriate licensing.
Frequently asked questions
Cerebrolysin is a complex mixture rather than a single defined molecule. It is produced by enzymatic and proteolytic hydrolysis of purified porcine cerebral cortex proteins, yielding a defined-process preparation that contains free amino acids and low-molecular-weight peptide fragments (typically below 10 kDa). The fragment composition includes peptides with neurotrophin-like activity (CNTF-like, BDNF-like signatures), though the specific bioactive components are not all individually identified. Because it's a mixture, Cerebrolysin doesn't carry a single CAS identifier, its identity is established by composition-fingerprint analysis (HPLC fingerprint, amino-acid profile) against a documented reference rather than by single-molecule mass-spec confirmation.
Cerebrolysin (brand name Cerebrolysin or Cerebrolyzin depending on the market) is approved as a prescription neurological biological in over 40 jurisdictions including Russia, China, India, the Philippines, several Eastern European markets (Ukraine, Poland, Czech Republic, Slovakia), and parts of Latin America. The approved indications typically include ischemic stroke recovery, traumatic brain injury, Alzheimer's disease, and vascular dementia. Cerebrolysin is NOT approved in the US, EU, UK, Canada, Australia, or Japan, these markets do not recognize the safety/efficacy data package as meeting their regulatory standards. Buyers should reference local registry status for their destination market before procurement.
Because Cerebrolysin is a multi-peptide hydrolysate rather than a single defined molecule, batch-to-batch identity is established by HPLC fingerprint comparison against a documented reference profile rather than by single-peak HPLC purity or single-mass spec confirmation. The fingerprint analysis covers retention-time profile (the characteristic peak pattern produced by the preparation's component peptide mix), total amino-acid content (typically reported by amino-acid analysis after acid hydrolysis), and microbial / endotoxin specifications. The released-batch COA reproduces the fingerprint chromatogram alongside the reference profile so buyers can visually confirm compositional consistency. This analytical approach is similar to how complex protein hydrolysates and traditional biological preparations are characterized elsewhere in the pharmaceutical industry.
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