Polaprezinc (L-Zinc Carnosine)

Polaprezinc (L-Zinc Carnosine)

(Powder, Tablets and Capsules)

Parameter Specification
Chemical Name Zinc (II) N-(3-aminopropionyl)-L-histidinate
CAS Number 107667-60-7
Molecular Formula C₉H₁₂N₄O₃Zn
Molecular Weight 289.61 g/mol
Purity (HPLC) ≥99.0%
Assay (Carnosine) 76.0% – 80.0%
Assay (Zinc) 21.5% – 23.0%
Test Method HPLC / Titration
Packaging 25kg/drum, double food-grade poly bags inside. Nitrogen-flushed foil packaging available.
Main Benefits Gastrointestinal mucosa protection, ulcer healing, antioxidant, anti-inflammatory
Application Pharmaceuticals, nutraceuticals, functional foods, veterinary medicine

Targeted Gut Health Solution: SRBio Polaprezinc (L-Zinc Carnosine)

SRBio Polaprezinc is a high-purity, chelated compound of L-carnosine and zinc, produced through patented crystallization technology. As a clinically validated gastrointestinal mucosal protective agent, it offers a dual-action mechanism: zinc promotes tissue repair and regeneration, while L-carnosine provides antioxidant and anti-inflammatory effects. This unique synergy makes Polaprezinc the gold-standard ingredient for gastric health applications, from pharmaceutical ulcer treatments to daily gut-support nutraceuticals.

Uncompromising Quality: SRBio’s Manufacturing Excellence

1. Precision Purity Control

Parameter SRBio Standard Test Method
Purity (HPLC) ≥99.0% HPLC
Carnosine Content 76.0% – 80.0% Titration
Zinc Content 21.5% – 23.0% Titration
Specific Optical Rotation +8.0° to +9.0° Polarimetry
Loss on Drying ≤5.0% Gravimetric
Lead (Pb) ≤2 ppm ICP-MS
Total Plate Count ≤1,000 CFU/g USP <2023>
Pathogens (E. coli/Salmonella) Negative USP <2023>

2. Advanced Chelation & Crystallization Technology

  • Proprietary Synthesis Process:

    • Precision Chelation: Our patented process ensures stoichiometric 1:1:1 molar ratio of zinc ion, L-carnosine, and water molecule, guaranteeing consistent bioactivity.

    • Multi-Stage Crystallization: Controlled cooling crystallization produces uniform crystals with optimal particle size distribution.

    • Gentle Drying: Low-temperature vacuum drying preserves molecular integrity and prevents degradation.

  • Particle Size Control:

    • Standard grade: 70% through 80 mesh.

    • Customizable particle size available for specific formulation needs (e.g., direct compression, suspensions).

  • Annual Capacity: 40+ metric tons of high-purity Polaprezinc, with flexible production scheduling to match customer demand cycles.

3. Stability & Shelf-Life Superiority

  • Accelerated Stability Data: Retains ≥98% potency after 24 months at 25°C/60% RH (ICH Q1A tested).

  • pH Adaptability: Stable in acidic environments (pH 1.2-3.0, typical gastric fluid); controlled release in neutral intestinal fluid (pH 6.8-7.4) to avoid systemic zinc overload.

  • Formulation Compatibility: No discoloration or efficacy loss in solid dosage forms after 24 months of storage. Microencapsulated grade available for liquid formulations to prevent sedimentation.

Scientific Evidence: Mechanism & Clinical Efficacy

1. Gastrointestinal Mucosa Targeting

  • Mechanism of Action:

    • Site-Specific Adhesion: Polaprezinc adsorbs to damaged gastric mucosa via electrostatic interaction, forming a protective barrier that lasts >6 hours (vs. 1-2 hours for ordinary zinc supplements).

    • Zinc Component: Promotes epithelial cell proliferation and collagen synthesis to accelerate mucosa repair.

    • Carnosine Component: Inhibits reactive oxygen species (ROS) and inflammatory factors (TNF-α, IL-8) to reduce mucosal irritation and inflammation.

  • Clinical Outcomes:

    • ↑82% ulcer healing rate after 4 weeks in clinical trials (vs. 56% for placebo) – Japanese pharmaceutical study.

    • Significant reduction in gastric mucosal injury scores in NSAID-induced gastropathy models.

2. Antioxidant & Anti-Inflammatory Effects

  • Mechanism: L-carnosine acts as a direct scavenger of hydroxyl radicals and singlet oxygen, while zinc stabilizes cell membranes and inhibits oxidative stress pathways.

  • Clinical Outcomes:

    • Reduces markers of oxidative stress (↓MDA, ↓8-OHdG) in gastric tissue.

    • Downregulates pro-inflammatory cytokines in models of chronic gastritis.

3. Safety Profile

  • Low Toxicity: LD₅₀ >5,000 mg/kg (rat, oral).

  • Long-Term Safety: No adverse effects observed in 12-month long-term toxicity studies.

  • Global Regulatory Status:

    • Japan: Listed as a prescription drug ingredient for peptic ulcer treatment.

    • EU: Approved as a Novel Food ingredient (NF) for nutraceuticals.

    • China: Included in the “Catalog of Food Additives and Nutritional Fortifiers.”

Formulation-Ready Advantages

Property SRBio Polaprezinc Conventional Zinc Supplements
Mucosa Adhesion Duration >6 hours 1-2 hours
Gastric pH Stability Stable (pH 1.2-3.0) Variable, often degraded
Systemic Zinc Absorption Controlled release Immediate, risk of overload
Particle Size Customizable Often inconsistent
Formulation Versatility Tablets, capsules, granules, liquids Limited

Application-Specific Benefits:

  • Pharmaceuticals:

    • Ulcer Treatment Tablets: 150 mg/tablet formulation clinically proven for peptic ulcer and chronic gastritis.

    • Combination Therapy: Can be co-formulated with bismuth subcitrate for enhanced ulcer repair.

  • Nutraceuticals:

    • Gastrointestinal Care Supplements: Ideal for daily gut health maintenance.

    • Prenatal Vitamins: Reduces gastric discomfort during pregnancy when combined with iron and other minerals.

    • “Gastric-Friendly” Powders: Synergistic blends with L-glutamine (e.g., 20 mg Polaprezinc + 500 mg glutamine).

  • Functional Foods:

    • Gastric-Friendly Meal Replacements: Fortification of oatmeals, shakes, and solid beverages targeting consumers with irregular diets.

    • Microencapsulated Grade: Prevents sedimentation in liquid formulations (oral suspensions, RTD beverages).

Supply Chain & Compliance Leadership

1. Audited Transparency & Traceability

  • Full Traceability: Batch-specific Certificate of Analysis (COA) with complete impurity, heavy metal, and microbial data. Batch records and reference samples retained for every production lot.

  • Dual Manufacturing Sites: Production across two certified facilities ensures business continuity and supply security.

  • On-Time Delivery: 99.7% on-time delivery rate with global logistics expertise (FOB, CIF, DDP terms).

2. Global Regulatory Certifications

Certification / Compliance Status / ID
EU Novel Food Approved
Japan Pharmaceutical Approval Listed as drug ingredient
China Food Additive Catalog Included
ISO 9001:2015 Certified
Third-Party Validations Available (SGS, Eurofins)
Comprehensive Documentation COA, TDS, MSDS, stability studies, method validation reports, toxicological data, allergen statements

3. Supply Chain Resilience

  • Strategic Raw Material Partnerships: Long-term agreements with key suppliers guarantee production stability.

  • Safety Stock: Strategic inventory maintained to accommodate urgent requirements.

  • Global Markets Served: North America, European Union, Southeast Asia, Australia, South America, Middle East.

  • Audit Support: Full support for virtual and on-site audits; pre-organized audit packages available for qualified partners.

Competitive Breakdown: SRBio vs. Market Alternatives

Key Deficiencies in Standard Polaprezinc/Zinc Carnosine:

  • Inconsistent Chelation: Poor stoichiometric control leads to variable zinc/carnosine ratios and reduced efficacy.

  • Particle Size Variability: Inconsistent crystal size causes blending and flow issues in manufacturing.

  • Limited Stability Data: Many suppliers lack comprehensive stability and safety documentation.

  • Regulatory Gaps: Insufficient dossiers for global market approvals (EU Novel Food, FDA, etc.).

SRBio’s Technology Edge:

Capability SRBio Typical Market Supplier
Purity (HPLC) ≥99.0% 95% – 98%
Chelation Precision 1:1:1 stoichiometric control Variable
Particle Size Control Customizable Often inconsistent
Regulatory Dossiers EU Novel Food approved, Japan pharma listed Limited or absent
Stability Data 24-month ICH-compliant Often 12 months or less
Production Capacity 40+ MT/year Variable, often smaller
Technical Partnership Full formulation support Limited

Partner Success Stories

Global Nutraceutical Brand:
“As our strategic Polaprezinc supplier for over 2 years, SRBio’s consistent quality and reliable supply have been crucial for our bestselling gastrointestinal support product line.”
— Procurement Director

European Pharmaceutical Company:
“The detailed CMC and stability data package from SRBio was instrumental in accelerating our regulatory filing. Their compliance rigor is truly partnership-level.”
— Regulatory Affairs Manager

US Supplement Manufacturer:
“Switching to SRBio for Polaprezinc provided us with a superior balance of purity, bioavailability, and cost-effectiveness. Their technical team collaborated seamlessly with our R&D on a novel chewable format.”
— Head of Product Development

Technical Partnership Program

1. Co-Development Services

  • Custom Formulations:

    • Gastroprotective Complexes: Polaprezinc + Bismuth Subcitrate for enhanced ulcer healing.

    • Gut Health Blends: Polaprezinc + L-Glutamine + Zinc Carnosine + Deglycyrrhizinated Licorice (DGL).

    • Prenatal Support: Polaprezinc + Iron + Folate (reduces gastric discomfort).

  • Custom Particle Engineering: Tailored particle size for direct compression, suspensions, or controlled release.

  • Stability Studies: ICH-guided protocols for your specific formulation matrix (tablets, capsules, liquids, gummies).

  • New Product Development: Collaborative R&D to expand health applications (e.g., oral mucositis, veterinary gut health).

2. Market-Ready Solutions

  • Private Label Kits: Turnkey formulas for gastrointestinal care capsules, powders, and chewable tablets.

  • Regulatory Support: Comprehensive dossiers for pharmaceutical (IND/NDA) and nutraceutical (NDI, Novel Food) submissions.

  • Technical Troubleshooting: Process optimization support for manufacturing challenges.

  • Rapid Sampling: Receive 100g / 500g trial batches with full COA + MSDS within 72 hours.

Request Your Polaprezinc Discovery Kit

Includes:

  • 100g High-Purity Polaprezinc (≥99.0%, HPLC-verified)

  • Full Certificate of Analysis (COA, TDS, MSDS)

  • Stability Data Summary (24 months, ICH-compliant)

  • Regulatory Dossier Excerpts (EU Novel Food, Japan pharma)

  • Formulation Guide for Gastrointestinal Applications

Partner with SRBio for Premium, Clinically Validated Polaprezinc

Choose SRBio as your trusted Polaprezinc partner for:

  • Guaranteed Supply Continuity backed by dual-site production

  • Uncompromising Quality Standards verified by third-party certifications

  • Competitive Total Cost of Ownership through efficient production

  • Strategic Technical Partnership with joint development support

  • Proven Product Performance supported by comprehensive data

  • Reliable Global Logistics with extensive regional experience

Start Your Supplier Qualification:

→ Email: admin@plantextractssr.com
→ Phone: +86-13720408392
→ WhatsApp/WeChat: +86-13720408392

Company Video

Xi’an SR Bio-Engineering Co., Ltd

Xi’an SRBio is a professional wholesale provider of many quality nutritional supplements products and  AMINO ACID Powde etc.

We supply powder, tablets and capsules.

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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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