Epitalon

I. Basic Chemical Identification (CAS Official Unique Code)

1. Basic Nomenclature

• Chinese Official Name: Epitalon Acetate (Epithalon Acetate, Tetrapeptide AEDG)
• Common Abbreviations: Epitalon, Epithalon, AEDG, Epithalamin
• English Full Name: Epitalon Acetate, L-Alanyl-L-α-glutamyl-L-α-aspartylglycine Acetate
• Amino Acid Sequence: L-Ala-L-Glu-L-Asp-Gly (AEDG); it is a natural-derived tetrapeptide, which is the core active fragment of the endogenous thymic peptide Epithalamin, with no terminal modification and maintaining the natural amino acid sequence to ensure biological homology.
• CAS Registry Number: 307297-39-8 (common CAS for acetate form; free base CAS is consistent with the acetate form in industrial applications, no need for separate distinction).
• Product Category: Synthetic Pharmaceutical Peptide, Biochemical API, Research-Grade Peptide Reagent, Anti-aging Peptide Raw Material
• EC/EINECS: 211-519-9 (registered for research and industrial use, compliant with EU chemical registration specifications).

2. Molecular Basic Parameters

• Molecular Formula: C₁₄H₂₂N₄O₉ (free base); C₁₆H₂₄N₄O₁₀ (acetate form).
• Average Molecular Weight: 390.35 Da (free base); 434.38 Da (acetate form).
• Exact Mass-to-Charge Ratio ([M+H]⁺): 391.1512 (free base); 435.1618 (acetate form)
• Theoretical Elemental Analysis (Acetate): C: 44.24%; H: 5.57%; N: 12.89%; O: 37.30%
• Isoelectric Point (pI): 4.25 (acidic peptide, consistent with its amino acid composition containing two acidic amino acids).
• pH Range for Solution Stability: 3.5 ~ 6.5 (stable in weak acid environment, easy to hydrolyze under strong acid and strong base conditions)

3. Chemical Structure

L-Ala-L-Glu-L-Asp-Gly-OH (no N-terminal modification, C-terminal free hydroxyl group; linear tetrapeptide structure, no disulfide bonds, with two acidic amino acids (Glu, Asp) carrying negative charges, which is the structural basis for binding to DNA small grooves).

II. Physical and Chemical Properties (Chemical Tested + Predicted Constants)

1. Appearance and Character

White to off-white loose powder, odorless, no visible foreign matter; no crystalline melting point, thermal decomposition occurs when heated above 180℃, belonging to peptide thermal decomposition material, consistent with the physical characteristics of small molecular peptides).

2. Thermodynamic Constants (Predicted Values)

• Boiling Point: 959.8±65.0 ℃ (predicted value, free base).
• Bulk Density: 1.466±0.06 g/cm³ (predicted value, consistent with the bulk density characteristics of small molecular peptides).

3. Solubility (Core Parameter for Chemical Preparation)

• Purified Water: Easily soluble, maximum solubility 80 mg/mL (184.2 mM, acetate form), better solubility than long-chain peptides due to its small molecular weight and acidic properties)
• Methanol, Acetonitrile: Slightly soluble, solubility ≤5 mg/mL
• Anhydrous Ethanol, Dichloromethane, DMF: Very slightly soluble, solubility ≤1 mg/mL
• Preparation Suggestion: Dissolve in purified water/sterile water for injection; assist dissolution with 30-35℃ water bath (avoid high temperature above 40℃ to prevent peptide bond cleavage), no need for ultrasound, dissolve quickly at room temperature

4. Solid State and Solution Stability

(1) Solid Powder

• Stable under light-proof, sealed, and inert gas (nitrogen) protection; resistant to oxidation, no obvious degradation under normal storage conditions
• -20℃: Shelf life 18 months; -80℃: Shelf life 36 months (longer than long-chain peptides due to simple structure and strong stability)

(2) Aqueous Stock Solution

• Aliquoted at -80℃: Stable for 12 months; aliquoted at -20℃: Use up within 2 months; 4℃ refrigeration: Use up within 7 days
• Strictly prohibit repeated freeze-thawing (each freeze-thaw will reduce purity by 1-2%), open placement at room temperature (stable for ≤8h at 25℃), and strong acid-strong base environment (pH<3.0 or pH>7.0 will accelerate hydrolysis)
• Degradation Triggers: Hydrolysis, peptide bond cleavage, deamidation; no N-terminal modification, but the natural sequence structure has strong anti-enzyme hydrolysis ability, and the degradation rate is significantly lower than that of ordinary linear peptides).

III. Synthesis Process (Solid-Phase Peptide Synthesis SPPS, Industrial General Route)

Epitalon adopts the standard Fmoc solid-phase peptide synthesis industrial process, with simple synthesis steps and high yield, and the specific chemical mass production process is as follows:

1. Resin Selection: Rink Amide MBHA Resin, C-terminal glycine (Gly) anchoring, which is the key step to ensure the integrity of the peptide sequence)
2. Sequential Amino Acid Condensation: Stepwise coupling according to the sequence Gly→Asp→Glu→Ala, using HBTU/HOBt as the condensing agent to ensure high coupling efficiency (each step coupling rate ≥99.5%)
3. N-terminal Modification: No N-terminal acetylation or amidation modification, retaining the natural L-alanine N-terminal structure, which is the core feature distinguishing it from other modified tetrapeptides).
4. Cleavage and Purification: Cleave the resin with TFA (trifluoroacetic acid) system to remove side chain protecting groups, with mild cleavage conditions to avoid peptide bond damage
5. Crude Product Refinement: Purification by Reverse-Phase High-Performance Liquid Chromatography (RP-HPLC), mobile phase is acetonitrile-water-trifluoroacetic acid system, to remove impurities such as incomplete peptides
6. Salt Conversion + Lyophilization: Salt conversion in acetic acid system (acetate finished product), sterile lyophilization to obtain loose powder, and packaging in aluminum-plastic vials to isolate moisture and oxygen
7. Terminal Quality Control: HPLC purity detection, MS mass spectrometry molecular weight verification, amino acid composition analysis, endotoxin detection, ensuring product quality meets industrial standards

IV. Industrial-Grade Quality Standards (Full Set of API COA Indicators)

Industry General Export-Grade Standard (≥99% Research/Chemical Grade), consistent with international peptide API quality requirements

V. Safety Data Sheet (Core of MSDS, Chemical Compliance)

1. Hazard Classification (GHS)

Non-hazardous chemical; no acute toxicity, no flammability, no corrosion, no oxidizability, no environmental hazard classification; high biological safety due to its homology with endogenous peptides).

2. Hazard Warnings

• For research laboratory use only; strictly prohibited for human injection, veterinary commercial use, food addition, and clinical medicine (not approved for human and animal therapeutic use)
• Dust Hazard: Inhalation of powder may cause slight respiratory irritation; avoid dust inhalation and direct skin contact; wear disposable gloves and masks during operation
• GHS Protection Labels: P261 (Avoid breathing dust), P262 (Avoid contact with skin and mucous membranes), P270, P280

3. First Aid Measures

• Inhalation: Move to a well-ventilated area; seek medical attention if breathing discomfort occurs
• Skin Contact: Rinse with clean water for 5-10 minutes; no irritating reaction, no special treatment needed
• Ingestion: Rinse mouth with clean water; do not induce vomiting; seek medical attention if discomfort occurs

4. Fire Fighting and Leakage

• Non-flammable; no toxic gas produced by combustion; dry powder and water-based fire extinguishers are applicable
• Powder Leakage: Collect in a sealed container, clean with negative pressure, and prevent dust diffusion; the collected powder shall be treated as hazardous waste

5. Disposal

Collect as sealed hazardous waste in the laboratory for centralized treatment; strictly prohibit direct discharge into water bodies and soil, in line with the disposal specifications of peptide reagents

VI. Storage, Transportation and Packaging Specifications (Chemical Logistics Requirements)

1. Routine Packaging

Lyophilized and sealed in vials: Small-specification APIs of 2mg, 5mg, 10mg, 25mg, 50mg, 100mg; lined with aluminum foil bags + nitrogen to isolate moisture and oxygen, prevent oxidation and hydrolysis, and ensure product stability during storage and transportation

2. Storage Conditions

• Powder: Frozen at -20℃, light-proof, dry, sealed, and protected by nitrogen; avoid contact with oxidants and strong acids/bases
• Strictly prohibit high temperature, humidity, and direct sunlight; storage environment humidity shall not exceed 60%

3. Transportation Requirements

• Full-process ice pack + cold chain insulation transportation; short-term room temperature shall not exceed 24h; avoid violent collision during transportation
• Land/Air transportation through non-hazardous general cargo channels; no restriction on hazardous goods transportation qualifications, compliant with international chemical transportation standards

VII. Biological Effects and Chemical Application Boundaries (Professional Distinction)

1. Molecular Mechanism of Action (Target Pathway)

• Core Functions: Telomerase activation, telomere length extension, epigenetic regulation, antioxidant stress, neuroendocrine regulation, immune function improvement).
• Downstream Pathways: Upregulation of hTERT gene expression (core of telomerase activation), inhibition of p53/p16 cell senescence pathway, activation of SOD/GPx antioxidant system, regulation of hypothalamic-pituitary-endocrine axis, promotion of thymus regeneration).
• Associated Signals: No obvious signal pathway activation, mainly through DNA binding to regulate gene expression, with high biological safety and no obvious side effects).

2. Application Boundaries (Chemical/Research Definition, Important Compliance)

(1) Legal Uses

Basic life science research, cell senescence mechanism research, animal model anti-aging experiment, peptide API R&D, cosmetic raw material R&D (external use only)

(2) Prohibited Uses

• Not prohibited by WADA (not included in the list of prohibited substances for athletes), but not approved for human use
• Unapproved for human drugs, clinical treatment, cosmetic medical beauty, and human health care (not approved by FDA, NMPA and other regulatory authorities)
• Unapproved commercial veterinary use, prohibited use in racehorses/race pets
• Addition as health product raw material and dietary supplement

VIII. Distinction of Easily Confused Products (Avoid Pitfalls in Chemical Procurement)

1. Epitalon (307297-39-8, tetrapeptide AEDG): Linear tetrapeptide, no terminal modification, core active fragment of Epithalamin, the main body of this document)[4];
2. Epithalamin (natural thymic peptide): Mixture of multiple peptides, including Epitalon, molecular weight 1000-5000 Da, not a single component, different from Epitalon);
3. TB500 (885340-08-9): Thymosin β4 fragment, 7-peptide, main function is tissue repair, completely different from Epitalon in sequence, CAS and mechanism);
4. BPC-157: Gastrointestinal repair peptide, independent sequence and mechanism, no homology with Epitalon, only used in combined research.

IX. Compliance and Industry Notes

• It is a research-specific fine chemical peptide raw material, not a drug, veterinary drug, or food additive; it is a common anti-aging research peptide in the industry.
• No national drug approval number, cosmetic approval number, or food approval number in China; it can be used for cosmetic raw material R&D but not for formal cosmetic production.
• Foreign Trade Export Classification: Biochemical reagents, synthetic peptide APIs; customs code classified as amino acid derivatives, compliant with international export standards.
• All commercial circulation is only marked with "For Research Use Only (RUO)", non-human use products; the product shall be used in strict accordance with research purposes.