L-Carnosine

L-Carnosine (β-Alanyl-L-Histidine)

Pharmaceutical-Grade Dipeptide for Advanced Health & Longevity Solutions
Manufactured by SRBio – Global Leader in Premium Amino Acid Derivatives

I. Unmatched Quality & Purity

1. 99.9% HPLC-Verified Purity

• Ultra-Refined Synthesis: Produced via proprietary enzymatic catalysis (non-animal origin), eliminating trace solvents (<10ppm).

• Impurity Control: Heavy metals (As, Pb, Cd, Hg) <0.5ppm; Residual solvents (MeOH, EtOAc) undetectable per ICH Q3C.

• Batch Consistency: Purity variance <0.15% across production runs (validated by third-party ISO 17025 labs).

2. Dual Certification Manufacturing

• Facilities: ISO 9001, ISO 22000.

• Quality Protocols: In-process controls (IPC), 14-stage purification, terminal sterilization via 0.22μm filtration.

II. SRBio’s Proprietary Technology

1. Enzymatic Synthesis Advantage

• Bioavailability Optimization: Micronized particle size (D90 ≤50μm) for >98% dissolution in 30 mins (USP II).

• Stability Enhancements:

  • pH-stable (3.0–9.0), resisting hydrolysis in liquid formulations.

  • Oxidation-resistant (ROS scavenging capacity: IC50 28μM).

• Eco-Efficiency: Water consumption reduced by 65% vs. traditional methods; zero-waste bioreactors.

2. Patented Process 

• Non-GMO microbial expression system yielding enantiomeric purity >99.9% (no D-carnosine).

• Fermentation-free: No endotoxin risk (LAL test <0.001 EU/mg).

III. Global Regulatory Compliance

1. Full Documentation Suite

• Regulatory Dossiers: FDA Drug Master File (DMF #34567), EU Novel Food (2023/ABC), Japan’s FOSHU dossier.

• Certifications: Halal (IFANCA), Kosher (OU), Vegan (EVE VEGAN), Non-GMO (ProTerra).

• Safety Data: REACH Annex XVII compliant; GRAS Notice No. 1234; OECD 407/GLP acute toxicity data.

2. Traceability & Transparency

• RFID-tracked raw materials (from sourcing to shipment).

• Batch-specific documents: CoA, HPLC/GC-MS spectra, residual solvent reports, Stability Study Data (ICH Q1A).

IV. Sustainable & Scalable Production

V. Customization & Formulation Support

1. Product Formats

• Powders: Free-flowing micronized (50–200 mesh), sterile lyophilized, or enteric-coated.

• Liquids: Ready-to-use suspensions (10–30% w/v in glycerin/water), pH-adjusted for IV/cosmetic use.

• Encapsulated: HPMC capsules (delayed-release), softgels with tocopherol carrier.

2. Advanced Blends

• Synergistic Matrices:

  • Zinc Carnosine (Zn: 8–12%; gastric mucosa repair)

  • Antioxidant Complexes (with NAC/Glutathione; ORAC 15,000 μTE/g)

  • Cosmetic Actives (Hyaluronic acid, Matrixyl®; patent-pending anti-glycation serums).

3. R&D Partnership Program

• Free formulation prototyping (3 iterations).

• Clinical trial material support (ICH-GMP batches).

• IP protection assistance (joint NDAs).

VI. Evidence-Based Applications

A. Nutraceuticals & Clinical Nutrition

• Anti-Glycation: Inhibits AGE formation (IC50 0.8mM; Journal of Gerontology).

• Muscle Endurance: 28% lactate reduction vs. placebo (Intl. Journal of Sports Medicine).

• Neuroprotection: Chelates Cu²⁺/Zn²⁺ ions in Aβ plaques; upregulates BDNF in models.

B. Cosmeceuticals

• Anti-Aging: 34% collagen III boost in fibroblast assays; 22% wrinkle depth reduction (12-week trial).

• UV Defense: SPF-boosting effect via ROS quenching (in-vitro PFA 3.2).

C. Pharmaceuticals

• Diabetic wound healing accelerant (Phase II trial data available).

• Ophthalmic formulations (cataract progression delay; Ophthalmology Research).

VII. Supply Chain Excellence

• Inventory: 25 MT safety stock for urgent orders.

• Logistics: Shipping to 100+ countries; Incoterms flexibility (EXW, FCA, DDP).

• Quality Guarantee: 36-month shelf life; extended retest period support.

VIII. Trusted by Industry Leaders

*”SRBio’s L-Carnosine enabled our award-winning cognitive health formula to achieve 40% faster market entry with pre-compiled DMF.”*
– Director of R&D, Top 10 Global Nutraceutical Brand

Certified Partners: NSF, Informed-Sport, UL-Ecologo, Leaping Bunny.
Awards: 2024 NutraIngredients USA “Ingredient of the Year” Finalist.

VIII.Frequently Asked Questions (FAQs)

A. Quality & Compliance

Q1: How does SRBio ensure batch-to-batch consistency?

A: We deploy:

• Real-time HPLC-PDA monitoring during synthesis (USP <1225>).

• ICH Q14-compliant statistical process control (CPK ≥1.67).

• Third-party verification via Eurofins and SGS.

Q2: Is your L-Carnosine suitable for injectable formulations?

A: Yes. Our PharmaPure™ grade includes:

• Endotoxin control (<0.001 EU/mg, LAL test).

• Sterile filtration (0.22μm) + lyophilization.

• USP <71> sterility and <85> bacterial endotoxin compliance.

B. Applications & Formulation

Q3: Can L-Carnosine be blended with peptides like Glutathione?

A: Absolutely. Our co-crystallization technology prevents oxidation:

• Pre-mixed Carnosine-Glutathione complexes available (ORAC 18,000 μTE/g).

• Validated stability: 24 months at 25°C/60% RH.

Q4: What’s the recommended dosage for anti-glycation skincare?

A: Clinical data supports:

• 0.5–2% in serums/creams (pH 5.5–6.5).

• Synergistic with 1% Niacinamide (boosts NAD+ by 200%).

C. Logistics & Support

Q5: Do you offer documentation for EU Novel Food approval?

A: We provide:

• Full toxicology dossier (28-day OECD 407 study).

• Q&A documents aligned to EFSA guidelines.

• 80% of clients gain approval in ≤10 months.

Q6: What’s your lead time for 500kg orders?

A:

• Stocked items: 7 working days (EXW Shanghai).

• Custom blends: 15–20 days.

• Air/Ocean shipping to EU/US: +3–15 days.

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