Specification	Detail
Item Number	SR008
Source Material	Serenoa repens (Saw Palmetto) Berries, Wild-Harvested from USA (Florida/Georgia)
CAS Number	84604-15-9
Key Specifications	45% Liposterolic Extract (Organic Hexane-Free); ≥25% Total Fatty Acids (GC-validated); ≥0.3% Phytosterols (HPLC)
Test Methods	GC-FID (Fatty Acid Profile), HPLC (Phytosterols), GC-MS (Pesticides)
Packaging	25kg/drum, nitrogen-flushed, with desiccant. Custom packaging available.
Main Benefits	Supports prostate health (BPH), helps maintain healthy testosterone metabolism, and promotes urinary flow.
Application	Men’s health supplements, prostate formulas, testosterone support capsules, and functional foods.

Pharma-Grade Saw Palmetto: Precision-Engineered for Prostate Health by SRBio

SRBio’s Saw Palmetto Extract is not just a botanical powder; it is a vertically integrated, pharma-grade ingredient solution. By controlling the supply chain from USA wild-harvesting to our China-based GMP-certified extraction facilities, we deliver a consistently potent, pure, and fully traceable liposterolic extract. Standardized to ≥25% fatty acids and verified for bioactivity, our extract is the definitive choice for evidence-based men’s health formulations.

Uncompromising Quality: SRBio’s Manufacturing Excellence

1. Vertically Integrated Purity & Potency

   • USA Sourced Berries: We partner directly with growers in Florida and Georgia to source mature, wild Serenoa repens berries, bypassing commodity traders and ensuring raw material authenticity.

   • Precision Active Standardization: We guarantee efficacy through strict control of key bioactive markers:

     • ≥25% Total Fatty Acids (GC-Validated): A precise profile of lauric, oleic, myristic, and linoleic acids—the key lipophilic actives for 5-alpha-reductase inhibition.

     • ≥0.3% Phytosterols (HPLC-Tested): Beta-sitosterol and other plant sterols quantified for synergistic support of prostate and urinary health.

   • Uncompromised Safety:

     • Heavy Metals: Lead (Pb) ≤0.2 ppm, Arsenic (As) ≤0.1 ppm (ICP-MS).

     • Solvent Residues: ≤5 ppm; fully compliant with USP <467> (GC-FID).

     • Pesticides: Meets stringent EU MRL requirements (EPA 8081B tested).

2. Advanced Cold CO₂ Extraction Technology

   • Patented Subcritical Process: Our in-house, proprietary subcritical CO₂ extraction operates at ≤35°C (Patent No. CN2023XXXXX). This low-temperature method preserves the full spectrum of heat-sensitive fatty acids, preventing degradation common in ethanol or hexane extraction.

   • 45% Liposterolic Concentrate: The process yields a rich, standardized 45% liposterolic extract with superior bioactivity and stability.

   • Eco-Impact: Our closed-loop system achieves 98% solvent recovery, resulting in zero waste and a significantly lower carbon footprint (EcoVadis Gold-certified process).

3. Full Blockchain Traceability

   • From Berry to Batch: Every production batch is fully traceable. A simple QR code scan provides access to:

     • Harvest date and origin of the USA berries.

     • DNA barcoding authentication of Serenoa repens.

     • Complete batch-specific lab reports (COA) including fatty acid profile, heavy metals, and pesticide screens.

Scientific Evidence: Mechanism & Efficacy

1. Prostatic Health & BPH Management

   • 5-Alpha-Reductase Inhibition: The fatty acid-rich liposterolic fraction is clinically shown to inhibit the enzyme 5-alpha-reductase, thereby reducing the conversion of testosterone to DHT (dihydrotestosterone) in prostate tissue.

   • Clinical Data: A 12-week human study (data on file) demonstrated significant improvement in International Prostate Symptom Scores (IPSS), including reduced nocturia and improved urinary flow rate.

2. Testosterone Metabolism Support

   • Hormonal Balance: By modulating DHT levels without directly affecting systemic testosterone, Saw Palmetto helps maintain a healthy hormonal environment for prostate and hair health.

Formulation-Ready Advantages

Application-Specific Benefits:

• Liquid-Filled Capsules & Softgels: Ideal for delivering the lipophilic extract with maximum bioavailability.

• Tablets & Dry Capsules: Our powder form is engineered for excellent flow and compressibility, compatible with high-speed tableting.

• Flavor-Masked Versions: Custom formulations available (e.g., peppermint or lemon) to improve patient compliance.

• Synergistic Blends: Ready-to-formulate combinations with Pygeum africanum, Nettle Root, Zinc, and Beta-Sitosterol for comprehensive prostate support formulas.

Supply Chain & Compliance Leadership

1. Audited Transparency & Global Compliance

   • Full Regulatory Dossiers: We provide turnkey documentation to support your global registrations, including:

     • USA: FDA Drug Master File (DMF) on file, Prop 65 report.

     • EU: THMPD (Traditional Herbal Medicinal Products Directive) support.

     • Canada: Health Canada compliance documents.

   • Allergen & GMO Statements: Third-party validated, free from common allergens.

2. Industrial-Scale Precision & Capacity

   • Certified Facilities: Our 50,000㎡ plant operates under GMP, ISO 22000, FSSC 22000, and is USDA/EU Organic certified, with Class 100,000 cleanrooms.

   • Robust Supply: Production capacity of 30+ metric tons per month (scalable to 50 tons), with a 50-ton ready inventory for urgent orders.

3. Ethical & Sustainable Sourcing

   • Eco-Responsibility: We protect wild Saw Palmetto populations through sustainable harvesting partnerships and our zero-waste CO₂ extraction process.

   • Vegan & Cruelty-Free: No animal-derived inputs are used in our processing.

Competitive Breakdown: SRBio vs. Market Alternatives

Key Deficiencies in Standard or Unverified Saw Palmetto Extracts:

• Inconsistent Potency: Many extracts lack guaranteed fatty acid and phytosterol levels, leading to unpredictable clinical outcomes.

• Solvent Residues: Extracts using hexane or high-temperature processing risk degradation of active compounds and residual solvent contamination.

• Lack of Traceability: Opaque supply chains make it impossible to verify source, authenticity, or purity.

SRBio’s Vertically Integrated Advantage:

• End-to-End Control: From USA berry sourcing to GMP extraction, we guarantee quality at every step.

• Superior Extraction Science: Our cold CO₂ process preserves the full lipid profile, ensuring maximum potency and stability.

• Blockchain-Verified Transparency: Unmatched traceability builds trust with your customers and regulators.

Technical Partnership Program

1. Co-Development Services

   • Shelf-Life Optimization: We provide 36-month stability data per ICH Q1A guidelines for your specific formulation (e.g., softgels, tablets).

   • Anti-Adulteration Program: DNA barcoding + HPTLC fingerprinting for every batch to guarantee authenticity and support your brand integrity.

2. Market-Ready Solutions

   • Custom Blends:

     • ProstaCare™: Saw Palmetto + Pygeum + Nettle Root + Zinc.

     • TestoSupport®: Saw Palmetto + Fenugreek + Boron.

   • Turnkey Formats: Private label kits for softgels (500mg), capsules, and liquid shots.

   • Frictionless Logistics: DDP shipping to 18 countries (USA/EU/Australia) with zero customs hassle.

Trusted by Industry Leaders

“SRBio’s 25% fatty acid extract reduced our production costs by 22% vs. European suppliers. Their DMF filing accelerated our FDA approval by 4 months.”
— Dr. Emily Shaw, CSO (USA)

“Blockchain traceability helped us secure UK’s Novel Food authorization in record time. Now our exclusive partner for all adaptogens.”
— Thomas Müller, Procurement Director (Germany)

📦 Limited-Time Launch Package

First 5 New Clients Receive:

• FREE 1kg Sample + Full Testing Portfolio ($1,200 value).

• FREE Regulatory Dossier (DMF, GMO Statement, Allergen Profile).

• Priority QC Slot – 15-day bulk order turnaround.

Contact our technical sales team today to request your trial batch and discuss your formulation goals.

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OEM SERVICE

We offer all-inclusive product development from consultation to delivery.
We make product proposals based on the customer’s requirements, from small to large lots.

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