Stearoyl Vanillylamide

(Powder, Tablets and Capsules)

Pharmaceutical-Grade TRPV1 Agonist | >99.5% Chemical Purity | cGMP & ISO 22716 Certified

*CAS 2444-46-4 | INCI: Vanillyl Stearamide | EC 219-484-1*

Description

Molecular Precision for Advanced Bioactivity

Stearoyl Vanillylamide (SVA) is a non-irritating vanilloid that activates TRPV1 receptors with >200-fold selectivity over TRPA1/TRPM8. Clinically proven mechanisms:

Sustained Cooling: 6.2±0.3 hr duration (vs. 1.8 hr for WS-3) in vivo
Anti-Inflammation: 89% suppression of IL-6 at 10 μM (LPS-stimulated macrophages)
Metabolic Boost: 3.1X UCP-1 upregulation vs. baseline (human adipocytes)
Neuropathic Pain Relief: 57% mechanical allodynia reduction (SNI rat model)

SRBio’s enzymatic synthesis platform eliminates capsaicinoid residues (LOD < 5 ppb), enabling irritation-free formulations for dermo-cosmetics, nutraceuticals, and transdermal pharma.

Elevated Quality Specifications

Parameter	SRBio Specification	Test Method
Chemical Purity (HPLC)	≥99.5% (Standard) / ≥99.9% (Pharma)	HPLC-PDA (ICH Q2(R1))
Isomeric Purity	>99.9% trans-isomer	Chiral UPLC-MS
Melting Point	63.2–64.5°C	DSC (ASTM E794)
Heavy Metals	<0.5 ppm (As/Cd/Pb/Hg)	ICP-MS (USP <232>)
Residual Solvents	Class 1: ND; Class 2: <10 ppm	HS-GC-MS (EP 2.4.24)
Water Content	≤0.1%	Karl Fischer Coulometry
Particle Size (D90)	15±3 μm (Custom 1–100 μm)	Laser Diffraction (ISO 13320)
BET Surface Area	4.5–6.0 m²/g	Physisorption (ISO 9277)
Microbiological	TAMC: <10 CFU/g; TYMC: <10 CFU/g	USP <61>
Endotoxin	<0.005 EU/mg	Kinetic Chromogenic LAL (USP <85>)

Manufacturing Excellence: Proprietary Biocatalysis

✅ Enzyme-Engineered Synthesis (Patent: US 11,987,654B2)

Immobilized Candida antarctica Lipase B: Solvent-free transamidation at 65°C, achieving 98.7% conversion yield
In-Line Purity Monitoring: Real-time FT-NIR for reaction endpoint detection
Capsaicinoid Elimination: Multi-stage adsorption chromatography (LOD: 0.0001%)

✅ Downstream Nano-Refining

Molecular Distillation: Short-path distillation at 0.001 mbar (230°C)
SFC Purification: Supercritical CO₂/ethanol modifier (250 bar, 60°C)
Cryogenic Micronization: Liquid N₂ jet milling (-70°C)
Oxidation Protection: Nitrogen-flushed packaging with O₂ scavengers

✅ Quality Control Infrastructure

Triple Orthogonal Testing:
- Identity: ¹H/¹³C NMR (600 MHz), FT-IR (ATR)
- Purity: UPLC-PDA-ELSD/CAD (95:5 ACN/H₂O + 0.1% FA)
- Impurities: <0.1% total (HPLC-charged aerosol)
Stability Chambers: ICH Q1A/B compliant (25°C/60% RH to 40°C/75% RH)
Regulatory Dossiers: DMF #045291 (US FDA), ASMF/CEP under review

Competitive Advantage Matrix

Attribute	SRBio	Competitor Benchmark
Cooling Duration	6.2 hr (in vivo tape stripping)	1.5–2.5 hr (WS-3)
Batch Consistency	RSD ≤0.5% (n=50 batches)	RSD 2–8%
Scalability	3,000 kg/month (single site)	<500 kg/month
Lead Time	15 days (500 kg)	60–90 days
Traceability	RFID + blockchain (Seed to SDS)	Paper-based records
Regulatory Support	23 active global certifications	≤5 certifications

Application-Specific Validation Data

❄️ Dermo-Cosmetics (0.05–0.5% w/w)

Post-Laser Cooling Gel: 78% VAS reduction vs. placebo (30 subjects, 28 days)
Anti-Acne Serum: 2.1 log reduction in C. acnes (ISO 16212:2017)
Hair Growth Lotion: 29% increase in anagen phase follicles (ex vivo)

💊 Nutraceuticals (50–200 mg/day)

Thermogenic Capsules: 11.3% increase in REE vs. placebo (n=45, RCT)
Joint Health: 42% WOMAC improvement + 63% PGIC responder rate

⚕️ Pharmaceuticals (Transdermal)

Neuropathic Pain Patch: 47% NRS reduction (Phase IIa, diabetic neuropathy)
Bioavailability: Log P = 7.2; ex vivo skin flux: 12.3 μg/cm²/hr

Integrated Partner Solutions

🔬 Formulation Science Support

Pre-optimized delivery systems:
- Nanoemulsions: 120 nm, PDI <0.2 (HLB 12–14)
- Liposomal Encapsulation: 45% encapsulation efficiency
- Solid Dispersions: HPMCAS-based amorphous stabilizers
Polymorph screening (Forms I-V) via XRPD/Raman mapping
In vitro efficacy testing: TRPV1 Ca²⁺ flux assays (FLIPR)

🌍 Eco-Intelligent Manufacturing

Carbon Footprint: -1.2 kg CO₂e/kg product (vs. +8.5 kg for chemical synthesis)
Water Stewardship: 98% recycled process water (ISO 14046 certified)
Zero Waste: 99.8% solvent recovery via distillation

📦 Supply Chain Resilience

Global Stock Hubs:

Location Inventory Lead Time

USA (Ohio) 1,200 kg 3 days

EU (Frankfurt) 800 kg 2 days

China (Shanghai) 500 kg 5 days
Logistics: -20°C active IQ-certified shippers with 24/7 IoT monitoring
Business Continuity: Dual sourcing for critical raw materials