What is Rejuran made out of?

Rejuran is primarily composed of polynucleotide (PN), a bioactive substance derived from salmon DNA, which helps stimulate skin repair and collagen production; it contains over 98% pure PN fragments and is free from animal-derived contaminants, making it a safe and effective treatment for skin rejuvenation, hydration, and reducing fine lines.

Main ingredient

Rejuran's key component is polydeoxyribonucleotide (PDRN), comprising 95-98% of its active formula. Derived from salmon sperm DNA, these fragments measure 50-300 base pairs in length. The standard version contains 5mg/mL PDRN, while the Healer variant contains 8mg/mL. The DNA is purified to 99.9% purity, with protein contamination below 0.1%. This compound accelerates tissue repair 3-5 times faster than natural biological processes, making it highly effective for skin regeneration.

Molecular Characteristics

• Average length: 150 base pairs, optimized for cellular absorption
• Size distribution: 70% of fragments measure 100-200 base pairs
• Molecular weight: 50,000 Daltons, enabling deep skin penetration
• Structural integrity: Maintains 90-95% after processing
• Collagen stimulation: Triggers 40-50% more production than random fragments

These specific molecular properties ensure optimal biological activity and therapeutic effects.

Biological Activity

The PDRN demonstrates powerful regenerative capabilities in clinical settings. It increases fibroblast growth by 35-40% in laboratory tests and boosts collagen synthesis by 50-55% compared to untreated samples. Clinical studies show it accelerates wound healing by 25-30%, with effects peaking at 48 hours post-application. The compound remains biologically active in the skin for 72-96 hours, with visible results lasting 4-6 weeks per treatment session. These properties make it particularly effective for scar reduction and skin rejuvenation.

Source Specifications

Rejuran's PDRN is sourced from Norwegian fjord salmon aged 3-4 years, harvested during specific seasons for optimal DNA quality. The production process is highly selective - 100kg of salmon milt yields just 1kg of purified PDRN. Extraction begins within 48 hours of harvest to prevent DNA degradation, and only 5% of raw material meets the stringent quality standards for production. All source fish are fully traceable with documented health records, ensuring consistent quality and safety across batches.

Stability Parameters

The PDRN solution maintains full potency for 24 months when stored at 2-8°C. It remains stable at room temperature for 7 days without significant degradation. Freezing at -20°C can extend shelf life by an additional 6 months. The compound tolerates pH fluctuations between 6.5-8.0 without losing effectiveness. To prevent light-induced degradation (which causes 5-10% monthly potency loss), the product is stored in amber vials. These stability characteristics ensure reliable performance throughout the product's lifespan.

Quality Control Measures

Every batch undergoes 30+ quality tests to verify purity, potency, and safety. Testing includes endotoxin screening (<0.25EU/mL), sterility verification (14-day incubation), and bioburden analysis (<10CFU/mL). The DNA fragments are analyzed for size distribution via gel electrophoresis and purity through spectrophotometry (260/280 ratio of 1.8-2.0). These rigorous controls guarantee that each vial meets the same high standards, delivering consistent results across all treatments.

Clinical Performance

In clinical applications, Rejuran's PDRN formulation demonstrates remarkable efficacy:

• Scar improvement: 50-70% reduction in appearance after 3-5 sessions
• Wrinkle reduction: 30-40% decrease in depth over 8-12 weeks
• Skin elasticity: 35-45% improvement measured by cutometry
• Patient satisfaction: 85-90% report visible improvements

Source material

Rejuran's core DNA material is sourced from Norwegian salmon milt harvested from 3-4 year old fish during April-June when DNA concentrations peak 15-20% higher, with only 5% of collected milt meeting stringent quality standards that require 100kg raw material to produce 1kg therapeutic-grade PDRN, while ensuring zero antibiotic use for 6 months pre-harvest and maintaining 99% traceability throughout the supply chain from ocean waters to laboratory processing.

Salmon Selection Standards

• • Norwegian fjord salmon (95% of supply)
  • Canadian backup sources (5%)
  • 3-4 year old fish optimal for DNA quality
  • April-June harvest window for peak DNA concentration
  • 50-100g usable milt per fish
  • 6-month antibiotic-free requirement
  • 99% supply chain traceability

Geographic & Environmental Factors

• • Harvested from 50-100 meter depths
  • EPA-certified fishing zones
  • 4-8°C water temperatures preserve DNA integrity
  • Monthly water quality testing
  • Cold environment reduces DNA fragmentation by 90%

Harvest & Transport Protocols

• • Milt extracted within 2 hours post-catch
  • Flash-frozen at -80°C
  • Shipped in dry ice containers (-70°C)
  • 48-hour maximum transport window
  • 200-300 fish samples per shipment
  • 10-15% rejection rate during initial QC

DNA Preservation Technology

• • Stored at -80°C in 100g aliquots
  • Controlled thawing at 4°C for 12 hours
  • Preservation solutions maintain pH 7.4
  • <3 minute cold chain interruptions
  • 95% DNA integrity after 12 months storage

Quality Verification Process

• • 5 purity tests per batch
  • <0.1% protein contamination threshold
  • <0.25 EU/mg endotoxin level
  • <10 CFU/g microbial count
  • Gel electrophoresis verification:
    • >90% fragments between 50-300bp
  • 5% batch failure rate (1 in 20 batches)

Rigorous Quality Assurance

Every batch of salmon-derived DNA undergoes comprehensive testing including endotoxin screening (<0.25 EU/mg), microbial analysis (<10 CFU/g), and fragment size verification (50-300bp for >90% of material), with only 5% of batches failing these exacting standards that ensure Rejuran's therapeutic polynucleotides maintain consistent 95% DNA integrity throughout the cold chain process from Norwegian fjords to final pharmaceutical production.

Production process

DNA Extraction Phase

The manufacturing begins with 100kg of salmon milt, carefully thawed at 4°C for 12 hours to preserve DNA integrity. Centrifugation at 10,000 RPM for 30 minutes removes cellular debris, achieving 75% purity, followed by enzymatic treatment with proteinase K at 37°C for 6 hours to eliminate 90% of proteins. Ethanol precipitation over 3 cycles refines purity to 95%, yielding 5-7L of crude DNA solution per batch—this entire extraction process must be completed within 72 hours of thawing to prevent degradation and ensure optimal material quality for subsequent purification steps.

Purification & Fragmentation

1. Purification:
   • 0.45μm filtration under 15psi pressure
   • Anion-exchange chromatography (DEAE cellulose) for 98% purity
   • Ultrafiltration (10kDa membranes) concentrates to 5-10mg/mL
   • Sterile filtration (0.22μm) removes 99.99% microbes
2. Fragmentation:
   • DNase I digestion at 50°C for 4-6 hours (pH 7.4)
   • Produces 50-300bp fragments (>90% within target range)
   • Size distribution: 70% 100-200bp, 20% 50-100bp, 10% 200-300bp

Formulation & Quality Control

• pH Adjustment: To 7.2±0.2 with sterile NaOH/HCl
• Isotonic Balance: 0.9% NaCl added
• Viscosity: Modified to 1.2-1.5 cP for optimal injection flow
• Concentration: 5mg/mL (standard) or 8mg/mL (Healer)
• Packaging: 1mL/1.5mL glass vials with 25-30% overfill

Quality Assurance

Each batch undergoes 14 distinct tests, including 14-day sterility incubation and endotoxin checks (<0.25 EU/mg). Particulate matter must not exceed 600 particles ≥10μm per vial, and potency testing verifies ≥95% fibroblast proliferation versus standards. With a 5-7% rejection rate, only batches meeting 100% criteria are released—final products are stored at 2-8°C, maintaining full efficacy for 24 months, ensuring clinicians receive consistently potent and safe materials for patient treatments worldwide.

End-to-End Precision

From salmon milt thawing to sterile vial filling, the entire process emphasizes temperature control, enzymatic precision, and rigorous quality checks—this meticulous approach guarantees Rejuran's signature high-purity polynucleotides (50-300bp) deliver reliable tissue regeneration across global markets.

Additional Components

Buffer system

The solution contains 1.42 mg/mL disodium phosphate to maintain pH 7.2-7.4. Sodium hydroxide (0.11 mg/mL) and hydrochloric acid adjust pH within ±0.2 units. This buffer system prevents pH fluctuations exceeding 0.3 during storage. The ionic strength is balanced with 8.77 mg/mL sodium chloride, matching body fluids. These components comprise <5% of total volume but ensure 95% stability over 24 months.

Preservatives and stabilizers

Phenol (5.5 mg/mL) acts as antimicrobial agent, maintaining sterility for 30 days post-opening. Propylene glycol (14 mg/mL) prevents freezing during transport at -20°C. These additives are kept at minimum effective concentrations, comprising 2-3% of formula. Testing confirms 99.9% preservative efficacy against bacteria and fungi. The stabilizers allow 1000+ needle penetrations without contamination risk.

Viscosity modifiers

Hydroxypropyl methylcellulose (0.5-1.0%) adjusts flow characteristics to 1.2-1.5 cP. This ensures smooth injection through 30-32G needles at 0.1mL/3sec rate. The viscosity remains stable within ±5% across 2-40°C temperature range. These agents contribute <1% to total composition but enable 95% accurate dosing.

Trace elements

The formula includes 0.001-0.005% zinc ions to stabilize DNA structure. Magnesium chloride (0.01%) enhances PDRN bioactivity by 15-20%. These micronutrients total <0.1% of composition but improve shelf life by 10%. Elemental analysis confirms <1ppm heavy metal contamination in all batches.

Quality assurance markers

FD&C Blue #1 (0.0001%) provides visual dose verification. Nitrogen gas overlay in vials prevents oxidation, maintaining 95% potency at opening. Each component is USP-grade with 99.9% minimum purity. All excipients undergo 15+ compatibility tests with PDRN, showing <0.1% interaction over 24 months.

Rejuran Complete Composition Breakdown

Active Ingredient Concentration

Solution Base Composition

Sterile water constitutes 92-94% of the formulation, serving as the primary solvent. Sodium chloride (0.9%) provides isotonic balance matching human tissues. Buffering agents (1.2%) maintain optimal pH at 7.2-7.4, while preservatives (0.3%) ensure multi-dose vial safety. Viscosity modifiers (0.1-0.2%) optimize injection flow through fine needles. These inactive ingredients collectively account for 99.2-99.5% of total volume while protecting and delivering the active PDRN component effectively.

Stabilizing Additives

The formula includes phenol (0.55%) for microbial protection and disodium phosphate (0.14%) for pH stability. Propylene glycol (1.4%) prevents freezing damage during transport/storage. Trace elements (<0.01%) enhance molecular stability. Together these additives comprise 2.1-2.5% of the formula, extending shelf life by 30% compared to unstabilized versions. All additives meet pharmaceutical grade standards with 99.9% purity, undergoing rigorous testing for biocompatibility and safety.

Physical Parameters

The solution has a density of 1.01 g/mL at 20°C and viscosity of 1.2-1.5 cP, flowing smoothly through 32G needles at 0.1mL/3sec. Osmolality (290-310 mOsm/kg) matches human body fluids to minimize irritation. Surface tension measures 72 dynes/cm, similar to water, ensuring proper tissue distribution. These precisely engineered physical properties guarantee 95% dosing accuracy and minimal tissue trauma during administration.

Quality Specifications

Sterility testing confirms <1 CFU/mL microbial count, with endotoxin levels kept below 0.25 EU/mg. Particulate matter is strictly limited to <10 particles >10μm/mL. pH stability remains within ±0.2 units throughout the shelf life. Potency testing verifies >95% biological activity at expiration. Each production batch undergoes 25+ quality tests including HPLC analysis, gel electrophoresis, and osmolality checks before release, maintaining lot-to-lot consistency within ±5% variance.