Target Solvent
Bacteriostatic Water (0.9% Benzyl Alcohol)
Store refrigerated
Validated Laboratory Standard
Revision 1 · Lyophilized Solid Powder
Enzymatically Stabilized N-Acetylated Telomerase Activator. Formulated for in-vitro research and laboratory analytical validation.
Enzymatically Stabilized N-Acetylated Telomerase Activator. Formulated for in-vitro research and laboratory analytical validation.
N-Acetyl Epitalon Amidate is an enzymatically stabilized synthetic derivative of the pineal peptide Epithalon (Ala-Glu-Asp-Gly). By incorporating an N-terminal acetyl group and a C-terminal amide cap (Ac-AEDG-NH2), the molecule gains profound steric resistance against aminopeptidases and carboxypeptidases in biological sera. In vitro studies confirm preserved nanomolar-affinity induction of human telomerase reverse transcriptase (hTERT) mRNA with extended circulatory and intracellular half-life.
Target Solvent
Bacteriostatic Water (0.9% Benzyl Alcohol)
Store refrigerated
Diluent Ratio
2 mL per 5 mg (2.5 mg/mL)
Slow laminar stream against vial wall; gentle rotational swirling.
Lyophilized Storage
Desiccated at -20°C.
Desiccated and protected from thermal spikes
Liquid Stability
2°C–8°C.
Refrigerated and light-protected
Pharmacokinetics / Half-Life
~4 to 6 Hours (Enhanced over native Epitalon)
Typical protocol duration: 10 to 20 Days (Biannual Cycle); Washout: 4 to 6 Months
| Standard Compound Mass | 10 mg active per vial |
| Recommended Diluent | Bacteriostatic Water (0.9% Benzyl Alcohol) |
| Diluent Volume Added | 2.0 mL |
| Resulting Concentration | 5.0 mg/mL |
| Syringe Volumetric Scale | U-100 Syringe (100 units = 1.0 mL | 1 unit = 50.0 mcg (0.01 mL)) |
Integrated reconstitution calculator and calibrated volumetric micro-plunger simulation.
Benchmark protocols from peer-reviewed clinical trials & institutional investigational programs.
| Escalation Stage & Phase | Target Dose | U-100 Mark (5mg / 2.0mL) | Cadence | Syringe Sync |
|---|---|---|---|---|
| In-Vitro Assay Titration Schedule (Days 1–3) | 250 mcg | 10.0 Units(0.10 mL) | 1x Daily | |
| In-Vitro Assay Titration Schedule (Days 4–15) | 500 mcg | 20.0 Units(0.20 mL) | 1x Daily | |
| In-Vitro Assay Titration Schedule (Days 16–20) | 1 mg | 40.0 Units(0.40 mL) | 1x Daily |
| Research Dose | Volume (mL) | U-100 Syringe Graduation Mark |
|---|---|---|
| 250 mcg | 0.10 mL | 10 Units 10 units |
| 500 mcg | 0.20 mL | 20 Units 20 units |
| 1,000 mcg | 0.40 mL | 40 Units 40 units |
| Research Dose | Calibrated Volume | U-100 Syringe Units | Graduation Description |
|---|---|---|---|
| 250 mcg | 0.05 mL (50 µL) | 5 Units | 10 units |
| 500 mcg | 0.1 mL (100 µL) | 10 Units | 20 units |
| 1,000 mcg | 0.2 mL (200 µL) | 20 Units | 40 units |
ISO 8537 Sterile Insulin Syringe Standard · Optical Meniscus Resolution & Volumetric Parallax Engineering
Detachable needles leave significant fluid trapped in the plastic hub collar. In peptide protocols, this causes substantial loss of active ingredient per administration.
| Barrel Capacity | Graduation Interval | Volume per Tick | Hub Dead-Space | Needle Spec | Suitability for 10 Units |
|---|---|---|---|---|---|
| 0.3 mL (30 Units)BEST FIT | 0.5 Unit | 5 µL (0.005 mL) | < 0.4 µL | 31G × 5/16" (8mm) Integrated Ultra-Fine | ✓ Accommodates 10 units |
| 0.5 mL (50 Units) | 1 Unit | 10 µL (0.010 mL) | < 0.8 µL | 30G–31G × 5/16" (8mm) Integrated | ✓ Accommodates 10 units |
| 1 mL (100 Units) | 2 Unit | 20 µL (0.020 mL) | < 2.1 µL | 29G–30G × 1/2" (12.7mm) Integrated | ✓ Accommodates 10 units |
Viewing the syringe from an angle introduces a 1.0–2.5 unit parallax error. Always raise the barrel to direct eye level against a high-contrast white background. Align the front edge of the top black plunger seal ring with the target line.
Standard 5/16" (8mm) laboratory dispensing needles are calibrated for direct 90° fluid transfer into target analytical matrix vials. If utilizing 1/2" (12.7mm) cannulas in deep laboratory vessels, introduce at a 45° angle to avoid contact with vessel sidewalls.
Stoichiometric supply planning, sequential reconstitution cadence, and itemized consumables BOM for N-Acetyl Epitalon Amidate.
Do NOT reconstitute all 10 vials simultaneously. Reconstitute one vial at a time as the active protocol requires. Once reconstituted with Bacteriostatic Water USP, a vial maintains stability for 28 days at +2°C to +8°C. Remaining unopened vials should be preserved in solid lyophilized cake form at -20°C to prevent hydrolysis and oxidation.
| Week | Study / Assay Phase | Weekly Target Dose | Syringe Draw (U-100) | Active Vial # | Cumulative Active Mass |
|---|---|---|---|---|---|
| Week 1 | Extended Course (Days 16–20) | 1.0 mg(7x/wk) | 20 Units(0.20 mL) | Vial #1(3mg rem) | 7.0 mg / 84.0 mg |
| Week 2 | Extended Course (Days 16–20) | 1.0 mg(7x/wk) | 20 Units(0.20 mL) | Vial #2(3mg rem) | 14.0 mg / 84.0 mg |
| Week 3 | Extended Course (Days 16–20) | 1.0 mg(7x/wk) | 20 Units(0.20 mL) | Vial #3(3mg rem) | 21.0 mg / 84.0 mg |
| Week 4 | Extended Course (Days 16–20) | 1.0 mg(7x/wk) | 20 Units(0.20 mL) | Vial #4(3mg rem) | 28.0 mg / 84.0 mg |
| Week 5 | Extended Course (Days 16–20) | 1.0 mg(7x/wk) | 20 Units(0.20 mL) | Vial #5(3mg rem) | 35.0 mg / 84.0 mg |
| Week 6 | Extended Course (Days 16–20) | 1.0 mg(7x/wk) | 20 Units(0.20 mL) | Vial #6(3mg rem) | 42.0 mg / 84.0 mg |
| Week 7 | Extended Course (Days 16–20) | 1.0 mg(7x/wk) | 20 Units(0.20 mL) | Vial #7(3mg rem) | 49.0 mg / 84.0 mg |
| Week 8 | Extended Course (Days 16–20) | 1.0 mg(7x/wk) | 20 Units(0.20 mL) | Vial #8(3mg rem) | 56.0 mg / 84.0 mg |
| Week 9 | Extended Course (Days 16–20) | 1.0 mg(7x/wk) | 20 Units(0.20 mL) | Vial #9(3mg rem) | 63.0 mg / 84.0 mg |
| Week 10 | Extended Course (Days 16–20) | 1.0 mg(7x/wk) | 20 Units(0.20 mL) | Vial #10(3mg rem) | 70.0 mg / 84.0 mg |
| Week 11 | Extended Course (Days 16–20) | 1.0 mg(7x/wk) | 20 Units(0.20 mL) | Vial #11(3mg rem) | 77.0 mg / 84.0 mg |
| Week 12 | Extended Course (Days 16–20) | 1.0 mg(7x/wk) | 20 Units(0.20 mL) | Vial #12(3mg rem) | 84.0 mg / 84.0 mg |
Study duration: 10 to 20 Days (Biannual Cycle) · Washout: 4 to 6 Months
| Period / Phase | Target Amount | Frequency | Notes & Calibration |
|---|---|---|---|
| Days 1–3Starting Baseline | 250 mcg | Daily | Initiation: Tolerance and pineal induction (10 units on U-100 syringe) |
| Days 4–15 | 500 mcg | Daily | Target Course: hTERT telomerase activation (20 units on U-100 syringe) |
| Days 16–20 | 1 mg | Daily | Extended Course: Maximal chromatin elongation (40 units on U-100 syringe) |
4-phase stability timeline, RP-HPLC degradation benchmarks, and storage SOPs for N-Acetyl Epitalon Amidate
Operating Window: +2°C to +8°C (36°F to 46°F)
Active working solution dissolved in Bacteriostatic Water USP (0.9% Benzyl Alcohol).
| Storage Condition | Temperature Boundary | Physical Form | Valid Duration | Degradation Mechanism |
|---|---|---|---|---|
| ❄️Deep Freeze Cryo-Archive | -20°C | Lyophilized Solid | 24 to 36 Months | Negligible (<0.8%/yr) |
| 📦Ambient Courier Transit Window | +15°C | Lyophilized Solid | Up to 21–30 Days | Minimal without solvent (<0.5%) |
| 💧Reconstituted Refrigerated Storage (2°C–8°C) | +2°C | Reconstituted Solution | 28 to 35 Days | Gradual deamidation >28 days |
| 🚫Critical Degradation Thresholds | >37°C | Degradation Hazard | Immediate Degradation Hazard | Rapid peptide cleavage & aggregation |
Slow laminar stream against vial wall; gentle rotational swirling.
N-Acetyl Epitalon Amidate displays an estimated half-life of ~4 to 6 Hours (Enhanced over native Epitalon). Typical study protocols run for 10 to 20 Days (Biannual Cycle) followed by a washout period of 4 to 6 Months.
High-purity lyophilized laboratory reference formulation with certified Certificate of Analysis (COA).
Standard Lyophilized Monograph
Enzymatically Stabilized N-Acetylated Telomerase Activator. Formulated for in-vitro research and laboratory analytical validation.
Store desiccated at -20°C upon receipt. Reconstitute strictly in a certified laminar airflow hood utilizing sterile disposable instruments. Avoid direct exposure to UV or fluorescent radiation.
| Net Active Mass | Target Solvent | Diluent Volume | Resulting Concentration | Syringe Graduation Scale |
|---|---|---|---|---|
| 5 mg Lyophilized Cake | Bacteriostatic Water USP (0.9% Benzyl Alcohol) | 2.0 mL | 2.50 mg/mL | 1 Unit = 25.0 mcg (0.01 mL) |
Swab vial septum with sterile 70% IPA pad. Inspect cake for vacuum seal integrity.
Introduce 2.0 mL solvent slowly down inner glass wall. Never spray directly on cake.
Swirl gently in horizontal circles until fully dissolved. Never shake or invert aggressively.
Rest at +2°C to +8°C for 10 minutes until solution is crystal clear before drawing.
| Phase | Target Active Dose | U-100 Syringe Graduation | Cadence & Pharmacological Purpose |
|---|---|---|---|
| Days 1–7 (Priming) | 250 mcg | 10.0 Units (0.100 mL) | Initial receptor priming; evaluate baseline physiological tolerance. |
| Weeks 2–4 (Saturation) | 375 mcg | 15.0 Units (0.150 mL) | Target assay maintenance; peak neurotrophic / metabolic response. |
| Weeks 5–6 (Taper & Washout) | 250 mcg | 10.0 Units (0.100 mL) | Receptor consolidation prior to mandatory 4-week washout cycle. |
RP-HPLC / LC-MS In-Vitro Assay
Purity Spec: ≥ 98.0% Area
Research Use Only (RUO)
NOT EVALUATED OR APPROVED BY FDA