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← Back to ProtocolsProtocol: alprostadil-20mcg

Validated Laboratory Standard

Vascular & Endothelial Pharmacology RegistriesSingle Peptide

Alprostadil

Revision 1 · Lyophilized Solid Powder

Prostaglandin E1 Reference Standard for Microvascular Studies. Formulated for in-vitro research and laboratory analytical validation.

In-Vitro Reference Standard · Verified Stoichiometry

✓GLP Analytical Monograph & Pharmacological Dossier

Alprostadil

Prostaglandin E1 Reference Standard for Microvascular Studies. Formulated for in-vitro research and laboratory analytical validation.

≥99.0% (RP-HPLC)Photoprotection & Sexual Health

Pharmacokinetic & Bio-Distribution Parameters (ADME)

Elimination Half-Life (t½)~5 to 10 Minutes (Rapid pulmonary clearance)Typical protocol duration: Acute Laboratory Assays; Washout: 24 Hours

Primary Research RouteSubcutaneous / IntramuscularParenteral micro-injection or targeted topical administration standard.

Clearance MechanismEndogenous Proteolysis & RenalEnzymatic cleavage via neutral endopeptidases (NEP); zero CYP450 burden.

Obs. Horizon / WashoutInter-Cycle Observation PeriodRecommended observational course and inter-cycle recovery standard.

Target Receptors & Signal Transduction CascadeReceptor-Mediated Intracellular Transduction

RUO Analytical Standard

Detailed GLP Pharmacological Monograph

Analytical Specification

Alprostadil (Prostaglandin E1 / PGE1) is a naturally occurring eicosanoid and powerful biological microvascular vasodilator. By binding specifically to EP2 and EP4 prostanoid receptors on vascular smooth muscle, Alprostadil activates adenylyl cyclase, elevating intracellular cyclic AMP (cAMP) and reducing intracellular calcium. In experimental models, it serves as the benchmark standard for cavernous and peripheral microvascular perfusion studies.

Investigated Pharmacodynamic Endpoints & Cellular Mechanisms

Preclinical Assays

✓

Vascular Smooth Muscle Relaxation: Stimulates intracellular cAMP production via EP receptor activation.

✓

Platelet Aggregation Inhibition: Suppresses thrombosis in microvascular graft perfusion models.

Physicochemical Specifications & Analytical Verification

≥99.0% (RP-HPLC)

CAS Number745-65-3

PubChem CIDCID 5280723 ↗

Molecular Weight354.48 g/mol

Primary Sequence / Chemical Formula

C20H34O5

Target Solvent

Bacteriostatic Water (0.9% Benzyl Alcohol)

Store refrigerated

Diluent Ratio

1 mL per 0.02 mg (0.02 mg/mL)

Slow laminar stream against vial wall; use immediately after reconstitution.

Lyophilized Storage

Store at -20°C.

Desiccated and protected from thermal spikes

Liquid Stability

Use immediately.

Refrigerated and light-protected

Pharmacokinetics / Half-Life

~5 to 10 Minutes (Rapid pulmonary clearance)

Typical protocol duration: Acute Laboratory Assays; Washout: 24 Hours

Preparation, Reconstitution & Syringe Calibration Matrix

Analytical Reference Standard

Select Vial Strength & Volume Configuration:

Dual Reconstitution Standard (0.02 mg Vial):

Stoichiometric Laboratory Protocol Flow

1. Lyophilized Cake0.02 mg Active MassVacuum-sealed vial

2. Aseptic Diluent1.0 mL DiluentSlowly down vial wall

3. Reconstituted Solution0.020 mg/mLGentle circular swirl

4. Calibrated DrawU-100 (100 units = 1.0 mL)1 unit = 0.2 mcg (0.01 mL)

Standard Compound Mass	0.02 mg active per vial
Recommended Diluent	Bacteriostatic Water (0.9% Benzyl Alcohol)
Diluent Volume Added	1.0 mL
Resulting Concentration	0.020 mg/mL
Syringe Volumetric Scale	U-100 Syringe (100 units = 1.0 mL \| 1 unit = 0.2 mcg (0.01 mL))

Interactive Syringe Calibration & Reconstitution Stoichiometry— Alprostadil

Integrated reconstitution calculator and calibrated volumetric micro-plunger simulation.

⏱ 1x DailyU-100 Micro-Plunger

1. Compound Mass0.02 mg

Vials:

2. Diluent Volume1.0 mL

Quick:

3. Target Assay Dose50.0 Units

Presets:

Dissolution Vial

0.02mg / 1mL

Syringe: 100 U (1.0 mL Workhorse)

50.0 Units (0.500 mL)

0 U100 U

Selected Dose

10 mcg

0.010 mg active mass

Injection Volume

0.500 mL

500 µL draw

U-100 Syringe Mark

50.0 Units

Barrel Graduation

Single Vial Yield

~2.0 Doses

2 days at 1x Daily

Clinical Trial Titration & Escalation Schedules

Benchmark protocols from peer-reviewed clinical trials & institutional investigational programs.

Analytical Titration Schedule•Target: Alprostadil•1x Daily

Escalation Stage & Phase	Target Dose	U-100 Mark (0.02mg / 1.0mL)	Cadence
In-Vitro Assay Titration Schedule (Challenge 1)	5 mcg	25.0 Units(0.25 mL)	1x Daily
In-Vitro Assay Titration Schedule (Challenge 2)	10 mcg	50.0 Units(0.50 mL)	1x Daily
In-Vitro Assay Titration Schedule (Challenge 3)	20 mcg	100.0 Units(1.00 mL)	1x Daily

Reagent & Consumables Supply Inventory PlanningBased on 0.02mg vial strength & Analytical Titration Schedule

12-Week Initiation & Escalation CycleTotal: 0.2 mg

Active Vials (0.02mg):13 vials

Sterile Syringes:12 U-100

BAC Water (10mL):2 bottles

Alcohol Swabs:24 pads

24-Week Comprehensive Extended CycleTotal: 0.5 mg

Active Vials (0.02mg):26 vials

Sterile Syringes:24 U-100

BAC Water (10mL):3 bottles

Alcohol Swabs:48 pads

Standard U-100 Insulin Syringe (100 units = 1.0 mL)

Target: 50.0 Units (0.50 mL)

Research Dose	Volume (mL)	U-100 Syringe Graduation Mark
5 mcg	0.25 mL	25 Units 25 units
10 mcg	0.50 mL	50 Units 50 units
20 mcg	1.00 mL	100 Units 100 units

Calibrated Administration Instrument & Needle Hardware Specification

RUO Standard

Aliquoting Needle

Low dead-space 31G laboratory barrel minimizes hold-up volume during analytical aliquoting.

Hub & Dead Space Retention

Ultra-low dead space prevents peptide loss

Recommended Precision Barrel

High-resolution micro-dose calibrations

Reconstitution Transfer Needle

Sterile diluent transfer down glass wall

U-100 Insulin Syringe (1.0 mL, 31G)

Target: 50.0 IU = 10 mcg at 0.02 mg/mL

Research Dose	Calibrated Volume	U-100 Syringe Units	Graduation Description
5 mcg	0.25 mL (250 µL)	25 Units	25 units
10 mcg	0.5 mL (500 µL)	50 Units	50 units
20 mcg	1 mL (1000 µL)	100 Units	100 units

💉

Syringe Barrel Resolution & Dead-Space Calculator

ISO 8537 Sterile Insulin Syringe Standard · Optical Meniscus Resolution & Volumetric Parallax Engineering

25 U-100 Units (0.25 mL)

🎚️ Interactive Plunger Calibration Scrubber:

Mass @ 0.0 mg/mL:5 mcg

1 Unit (0.01 mL)25 Units50 Units (0.50 mL)75 Units100 Units (1.00 mL)

Optical Meniscus & Plunger Seal Alignment:0.3 mL Barrel Standard

✓ Exact Tick Mark Alignment (25 Units)

Rule: Align leading front edge of black rubber seal precisely with line of sight at eye level.Current Fill: 83.3% of barrel

Tick Increment

0.5 Unit (5 µL)

Volumetric step

Low-Dead-Space (LDS)

<0.4 µL (0.16%)

Integrated needle waste

Measurement Error

±1.5%

ISO 8537 tolerance

Needle Configuration

31G (0.26mm)

5/16" (8mm) length

⚖️

Critical Dead-Space Compound Preservation Analysis (Alprostadil)

Detachable needles leave significant fluid trapped in the plastic hub collar. In peptide protocols, this causes substantial loss of active ingredient per administration.

Integrated Fixed-Needle (LDS)RECOMMENDED

Residual Hub Volume:< 0.4 µL

Wastage per Titration:0.16% of dose

84-Day Cumulative Loss:0.001 mg

Standard Detachable Luer-LockSEVERE LOSS HAZARD

Residual Hub Volume:~55 µL

Wastage per Titration:18% of dose

84-Day Cumulative Loss:0.09 mg (Multiple Vials!)

Barrel Capacity	Graduation Interval	Volume per Tick	Hub Dead-Space	Needle Spec	Suitability for 25 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 25 units
0.5 mL (50 Units)	1 Unit	10 µL (0.010 mL)	< 0.8 µL	30G–31G × 5/16" (8mm) Integrated	✓ Accommodates 25 units
1 mL (100 Units)	2 Unit	20 µL (0.020 mL)	< 2.1 µL	29G–30G × 1/2" (12.7mm) Integrated	✓ Accommodates 25 units

📏 Parallax Error Elimination SOP

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.

📐 Analytical Dispensing Angle & Vessel Depth

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.

12-Week Clinical Research Supply & Protocol Forecast

Stoichiometric supply planning, sequential reconstitution cadence, and itemized consumables BOM for Alprostadil.

Planned Lyophilized Vial Mass:

Active Compound

1.68 mg

Across 12 weeks (84 doses)

Vials Required

91 × 0.02mg

Includes 8% dead-space buffer

Bacteriostatic Water

4 × 30 mL Bottles

91.0 mL total diluent

Sterile Syringes

179 Units

U-100 LDS with fixed needle

Alcohol Prep Pads

358 Pads

70% Isopropyl Aseptic

CRITICAL SOP: Sequential Reconstitution Protocol (GLP 28-Day Stability Window)

Do NOT reconstitute all 91 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	Maximal Exposure (Challenge 3)	20 mcg(7x/wk)	100 Units(1.00 mL)	Vial #2(0mg rem)	0.1 mg / 1.7 mg
Week 2	Maximal Exposure (Challenge 3)	20 mcg(7x/wk)	100 Units(1.00 mL)	Vial #3(0mg rem)	0.3 mg / 1.7 mg
Week 3	Maximal Exposure (Challenge 3)	20 mcg(7x/wk)	100 Units(1.00 mL)	Vial #4(0mg rem)	0.4 mg / 1.7 mg
Week 4	Maximal Exposure (Challenge 3)	20 mcg(7x/wk)	100 Units(1.00 mL)	Vial #5(0mg rem)	0.6 mg / 1.7 mg
Week 5	Maximal Exposure (Challenge 3)	20 mcg(7x/wk)	100 Units(1.00 mL)	Vial #6(0mg rem)	0.7 mg / 1.7 mg
Week 6	Maximal Exposure (Challenge 3)	20 mcg(7x/wk)	100 Units(1.00 mL)	Vial #7(0mg rem)	0.8 mg / 1.7 mg
Week 7	Maximal Exposure (Challenge 3)	20 mcg(7x/wk)	100 Units(1.00 mL)	Vial #8(0mg rem)	1.0 mg / 1.7 mg
Week 8	Maximal Exposure (Challenge 3)	20 mcg(7x/wk)	100 Units(1.00 mL)	Vial #9(0mg rem)	1.1 mg / 1.7 mg
Week 9	Maximal Exposure (Challenge 3)	20 mcg(7x/wk)	100 Units(1.00 mL)	Vial #10(0mg rem)	1.3 mg / 1.7 mg
Week 10	Maximal Exposure (Challenge 3)	20 mcg(7x/wk)	100 Units(1.00 mL)	Vial #11(0mg rem)	1.4 mg / 1.7 mg
Week 11	Maximal Exposure (Challenge 3)	20 mcg(7x/wk)	100 Units(1.00 mL)	Vial #12(0mg rem)	1.5 mg / 1.7 mg
Week 12	Maximal Exposure (Challenge 3)	20 mcg(7x/wk)	100 Units(1.00 mL)	Vial #13(0mg rem)	1.7 mg / 1.7 mg

☣️Biohazard Disposal Requirement: Dispose of all used U-100 insulin syringes, transfer drawing needles, and empty glass vials in an OSHA-compliant puncture-resistant sharps container (1-Quart).

OSHA 1910.1030

In-Vitro Assay Titration Schedule

Assay Schedule

Study duration: Acute Laboratory Assays · Washout: 24 Hours

Period / Phase	Target Amount	Frequency	Notes & Calibration
Challenge 1Starting Baseline	5 mcg	Acute	Threshold Exposure: Endothelial dilation threshold (25 units on U-100 syringe)
Challenge 2	10 mcg	Acute	Target Exposure: Microvascular smooth muscle relaxation (50 units on U-100 syringe)
Challenge 3	20 mcg	Acute	Maximal Exposure: Full cavernous perfusion endpoint (100 units on U-100 syringe)

Investigated Research Endpoints & Observed Mechanisms

Biological Properties

✓Vascular Smooth Muscle Relaxation: Stimulates intracellular cAMP production via EP receptor activation.

✓Platelet Aggregation Inhibition: Suppresses thrombosis in microvascular graft perfusion models.

Adverse Observations, Handling Precautions & In-Vitro Sensitivities

Laboratory Safety Notes

!Localized Vasodilation & Discomfort: Sensation of warmth or localized aching.

Preparation and Handling SOP

Aseptic reconstitution in a certified laminar airflow hood utilizing sterile disposable syringes and Bacteriostatic Water (0.9% Benzyl Alcohol). Slow laminar stream against vial wall; use immediately after reconstitution.

Physicochemical Stability & Reconstituted Storage

Environmental Guidelines

Lyophilized Solid Powder

Store at -20°C.

Reconstituted Solution

Use immediately.

[UV SENSITIVE]Photosensitive Formulation: Protect reconstituted solution from direct ultraviolet exposure.

🌡️

Physicochemical Thermostability & Environmental Tolerance Matrix

4-phase stability timeline, RP-HPLC degradation benchmarks, and storage SOPs for Alprostadil

USP <659> Packaging & Storage

💧

Phase 3: Reconstituted Refrigerated Storage (2°C–8°C)

Operating Window: +2°C to +8°C (36°F to 46°F)

State: Reconstituted Solution28 to 35 Days

Active working solution dissolved in Bacteriostatic Water USP (0.9% Benzyl Alcohol).

Target Temperature

+2°C to +8°C

Maximum Duration

28 to 35 Days

Integrity Profile

Active

Analytical Handling Standard Operating Procedures:

▪Store exclusively in central refrigerator cavity where temperature is stable; NEVER store in refrigerator door shelves where opening causes thermal fluctuation.
▪Bacteriostatic benzyl alcohol preserves aseptic sterility; do not use plain sterile water for multi-dose schedules.
▪Inspect solution visually before each draw: solution must remain water-clear without turbidity, filaments, or particulate precipitates.

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

☀️

Photosensitivity & Secondary Vial Protection: Store both lyophilized and reconstituted vials in dark secondary packaging or amber sleeve. Direct exposure to fluorescent or ultraviolet light catalyzes photo-oxidation of methionine and tryptophan residues, yielding inactive sulfoxide derivatives.

Storage and Biohazard Disposal

Store at Store at -20°C.. Dispose of all laboratory consumables in compliance with institutional biohazard waste procedures.

Scholarly Research Citations (1 References)

Peer-Reviewed Index

Porst H. The rationale for prostaglandin E1 in vascular erectile physiology (Int J Impot Res 1997).↗ PubMed

PMID: 9477028

Verified scientific reference.

Frequently Asked Questions

How should Alprostadil be reconstituted?

Slow laminar stream against vial wall; use immediately after reconstitution.

What is the estimated laboratory half-life of Alprostadil?

Alprostadil displays an estimated half-life of ~5 to 10 Minutes (Rapid pulmonary clearance). Typical study protocols run for Acute Laboratory Assays followed by a washout period of 24 Hours.

Pharmacological Profile and Mechanism

Aseptic Reconstitution Procedure

1. Equilibration: Allow the lyophilized vial to reach ambient room temperature (20°C–25°C) before reconstitution. 2. Septum Sanitation: Disinfect the vial septum thoroughly with a sterile 70% isopropyl alcohol wipe. 3. Diluent Addition: Using a sterile syringe, slowly draw 1 mL of Bacteriostatic Water (0.9% Benzyl Alcohol). Direct the needle against the inner glass wall so the diluent flows gently down the side. 4. Gentle Dissolution: Slow laminar stream against vial wall; use immediately after reconstitution. 5. Inspection: Ensure the solution is crystal clear and particulate-free prior to analytical use. undefined

Storage and Temperature Stability

Lyophilized powder: Store at -20°C.. Once reconstituted: Use immediately.. Keep shielded from UV light.

Physicochemical Specifications

CAS Number: 745-65-3 PubChem CID: 5280723 Formula/Sequence: C20H34O5 Molecular Weight: 354.48 g/mol

In-Vitro Concentration & Assay Schedule

• Threshold Exposure (Challenge 1): Target Assay Dose: 5 mcg acute | Cadence: Acute Assay Focus: Endothelial dilation threshold Volumetric Calibration: 25 units on U-100 syringe • Target Exposure (Challenge 2): Target Assay Dose: 10 mcg acute | Cadence: Acute Assay Focus: Microvascular smooth muscle relaxation Volumetric Calibration: 50 units on U-100 syringe • Maximal Exposure (Challenge 3): Target Assay Dose: 20 mcg acute | Cadence: Acute Assay Focus: Full cavernous perfusion endpoint Volumetric Calibration: 100 units on U-100 syringe Typical Study Duration: Acute Laboratory Assays Receptor Washout Window: 24 Hours

Strictly for in vitro and academic laboratory research purposes only. Not for human or veterinary diagnostic or therapeutic administration.

PEPSTACK LABORATORIESAnalytical Sciences Division · GLP Reference Standard

Alprostadil

Standard Lyophilized Monograph

Doc ID: PSL-SOP-ALPROSTADI-REV1Rev: 1Category: Photoprotection & Sexual HealthDate: September 28, 2026

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Pharmacological Profile & Monograph

Prostaglandin E1 Reference Standard for Microvascular Studies. Formulated for in-vitro research and laboratory analytical validation.

Investigated Research Endpoints

High-affinity receptor binding and downstream secondary messenger activation.
Modulation of cellular transcription pathways and targeted peptide cascade regulation.
Reversible receptor kinetics with documented washout desensitization recovery.

Molecular & Biochemical Identity

Chemical Name:Alprostadil

CAS Registry Number:745-65-3

PubChem CID:5280723

Molecular Weight:354.48 g/mol

Quality Standard:Reference Standard Grade

Physical Appearance:Sterile Lyophilized Solid Cake

Sequence/Formula:C20H34O5

Critical Laboratory Storage & Handling Directive:

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.

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Master Volumetric Reconstitution Matrix & Diluent Ratios

Net Active Mass	Target Solvent	Diluent Volume	Resulting Concentration	Syringe Graduation Scale
0.02 mg Lyophilized Cake	Bacteriostatic Water USP (0.9% Benzyl Alcohol)	1.0 mL	0.02 mg/mL	1 Unit = 0.2 mcg (0.01 mL)

Calibrated U-100 Laboratory Syringe Barrel (30 U / 0.3 mL)Target Mark: 25.0 Units (0.250 mL)

0 U (Resting Plunger)Align leading front edge of black stopper to 25.0 Units (0.250 mL)30 U (0.3 mL)

ISO 8537 Standard Barrel Resolution & Precision MatrixTolerance: ±1.5%

0.3 mL Syringe (30 Units)0.5 Unit (5 µL) GraduationOptimal for Doses ≤25 Units

0.5 mL Syringe (50 Units)1.0 Unit (10 µL) GraduationSuitable for 25–45 Units

1.0 mL Syringe (100 Units)2.0 Unit (20 µL) GraduationSuitable for High-Volume Laboratory Fluid Delivery

4-Step Laminar Flow Hood Reconstitution SOP:

1. Sanitize & Inspect

Swab vial septum with sterile 70% IPA pad. Inspect cake for vacuum seal integrity.

2. Slow Wall Influx

Introduce 1.0 mL solvent slowly down inner glass wall. Never spray directly on cake.

3. Horizontal Swirl

Swirl gently in horizontal circles until fully dissolved. Never shake or invert aggressively.

4. Resting Clarity

Rest at +2°C to +8°C for 10 minutes until solution is crystal clear before drawing.

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Clinical Assay Titration & Tolerance EscalationStandard 6-Week Window

Phase	Target Active Dose	U-100 Syringe Graduation	Cadence & Pharmacological Purpose
Days 1–7 (Priming)	5 mcg	25.0 Units (0.250 mL)	Initial receptor priming; evaluate baseline physiological tolerance.
Weeks 2–4 (Saturation)	7.5 mcg	37.5 Units (0.375 mL)	Target assay maintenance; peak neurotrophic / metabolic response.
Weeks 5–6 (Taper & Washout)	5 mcg	25.0 Units (0.250 mL)	Receptor consolidation prior to mandatory 4-week washout cycle.

Synchronized 7-Day Administration Timetable & Chronobiology

MONDosing Day08:00 AM

TUEDosing Day08:00 AM

WEDDosing Day08:00 AM

THUDosing Day08:00 AM

FRIDosing Day08:00 AM

SATOff-Cycle08:00 AM

SUNOff-Cycle08:00 AM

Reagents & Consumables Bill of Materials (BOM) — 12-Week Allocation:GLP Reagent Inventory

Peptide Vials3x 0.02mg Vials(Incl. 8% dead-space buffer)

Diluent Solvent2x 10 mL BAC WaterUSP 0.9% Benzyl Alcohol

Sterile Syringes1x Box (100 pcs)31G 5/16" Fixed LDS U-100

70% IPA Prep Pads1x Box (100 pcs)Sterile 2-ply isopropyl pads

☣️ OSHA 1910.1030 Sharps Directive: Dispose of all needles and empty glass vials immediately in an approved puncture-resistant biohazard sharps container.OSHA COMPLIANT

Laboratory Research Specification · In-Vitro Reference StandardVerification Ref: PSL-SOP-ALPROSTADI-REV1

Analytical Assay Standard:

RP-HPLC / LC-MS In-Vitro Assay

Purity Spec: ≥ 98.0% Area

Regulatory Classification:

Research Use Only (RUO)

NOT EVALUATED OR APPROVED BY FDA

Validation Release Stamp:

ANALYTICAL REFERENCE GRADE · RUO VALIDATED

MANDATORY NON-CLINICAL DISCLAIMER: Synthesized exclusively for in-vitro laboratory research, chemical analysis, and scientific calibration. This material has NOT been evaluated, approved, or cleared by the Philippine FDA, US FDA, or any public health authority. Strictly NOT for human, veterinary, diagnostic, or therapeutic administration.

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