| Core Attribute | Specification |
|---|---|
| Product Name | L-5-Methyltetrahydrofolic Acid, Calcium Salt (L-5-MTHF Calcium) |
| CAS Number | 151533-22-1 |
| Molecular Formula | C₂₀H₂₃CaN₇O₆ |
| Molecular Weight | 497.5 g/mol |
| Assay (HPLC) | > 99.0% (on anhydrous basis) |
| Appearance | Yellow to orange crystalline powder |
| Solubility | Freely soluble in water |
| Chiral Purity | 100% L-Isomer (Natural, bioactive form) |
| Packaging | Light-protected, nitrogen-flushed, multi-layer foil bags in fiber drum. Net weight: 25 kg/drum |
| Primary Benefits | Universal, ready-to-use active folate; bypasses MTHFR genetic bottlenecks; supports prenatal health, mood, and cardiovascular function |
| Application | Prenatal vitamins, active pharmaceutical ingredients (API), mental health supplements, food fortification |
SRBio L-5-Methyltetrahydrofolate Calcium: The Active Folate Solution
SRBio L-5-MTHF Calcium: A premium, pharmaceutical-grade active folate, precisely engineered to be the direct, bioavailable form of vitamin B9. Utilizing proprietary fermentation and stabilization technologies, we deliver the pure, naturally occurring calcium salt of L-5-methyltetrahydrofolate—the only form of folate that can be directly utilized by the human body, regardless of genetic variations (MTHFR). This ensures superior absorption, enhanced stability, and predictable efficacy for the world’s most demanding nutritional and pharmaceutical applications.
Product Excellence: The SRBio Active Folate Advantage
1. High Bioavailability: The Ready-to-Use Active Form
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Bypasses Metabolic Conversion: Unlike folic acid, which requires multi-step enzymatic conversion (dependent on a functional MTHFR enzyme), SRBio L-5-MTHF is the final, bioactive form of folate. It is ready for immediate participation in critical metabolic pathways: DNA synthesis, homocysteine regulation, and neurotransmitter production.
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Universal Efficacy: Ideal for the significant portion of the population with genetic polymorphisms (MTHFR C677T) that impair folic acid conversion.
2. Superior Stability: Advanced Crystallization Technology
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Overcoming the Folate Stability Challenge: Folates are inherently sensitive to heat, oxygen, and moisture. Our patented stabilization technology, involving controlled crystallization and a protected matrix, ensures industry-leading stability.
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Extended Shelf-Life: Formulated to retain >95% potency for 36 months in finished products under standard storage conditions (25°C/60% RH), as verified by ICH Q1A stability studies. This guarantees efficacy throughout your product’s lifecycle.
3. Excellent Solubility & Formulation Versatility
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High Water Solubility: Freely soluble in water, enabling seamless integration into a wide array of formats, from traditional tablets and capsules to liquid drops, gummies, and parenteral nutrition.
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Multiple Grades Available: Offered in Pharmaceutical (API), Nutraceutical, and Food grades, each with tailored quality specifications to meet diverse global regulatory requirements.
Uncompromising Quality: SRBio’s Manufacturing & Supply Chain Excellence
Our leadership in L-5-MTHF is built on a foundation of integrated manufacturing, rigorous quality control, and supply chain reliability.
1. Manufacturing Expertise: 15+ Years of Folate Specialization
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Proprietary Fermentation & Purification: We utilize advanced fermentation technology followed by a multi-step purification process that ensures >99% purity and minimizes unwanted isomers, specifically guaranteeing 100% of the active L-isomer.
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High Production Capacity: Annual manufacturing capacity exceeds 50 metric tons, with flexible production scheduling to meet fluctuating demand cycles and ensure supply security.
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Vertical Integration: End-to-end production oversight, from control of key raw materials to final packaging, ensures complete batch-to-batch traceability and consistency.
2. Quality & Compliance Leadership: Third-Party Verified
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Certified Facilities: Production takes place in cGMP, ISO 9001:2015, and FSSC 22000 certified facilities, with multiple quality checkpoints throughout the process.
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Advanced Analytical Capabilities: In-house QC lab equipped with HPLC, GC-MS, and NMR for rigorous raw material, in-process, and finished product testing.
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Comprehensive Documentation: Every batch is supplied with a detailed Certificate of Analysis (CoA). We provide full regulatory support packages, including stability data, TSE/BSE statements, allergen declarations, and country-specific dossiers to facilitate global market access.
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Proven Track Record: “Zero quality rejections from major EU pharmaceutical clients over a 5-year partnership.”
3. Supply Chain Reliability: Global Logistics Expertise
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Supply Security: Multiple production lines guarantee 99.5% operational uptime, and strategic partnerships for raw materials buffer against market fluctuations.
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Global Logistics: Extensive experience with FOB, CIF, and DAP terms ensures smooth delivery to markets across North America, the EU, Southeast Asia, Australia, and beyond.
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On-Time Delivery: A proven 99.7% on-time delivery record, with strategic inventory buffers to accommodate urgent orders.
Technical Specifications
| Parameter | Specification | Test Method |
|---|---|---|
| Appearance | Yellow to orange crystalline powder | Visual Inspection |
| Identification (HPLC) | Retention time matches reference standard | HPLC |
| Assay (L-5-MTHF) | > 99.0% (on anhydrous basis) | HPLC |
| Chiral Purity (L-isomer) | 100% (No detectable D-isomer) | Chiral HPLC |
| Related Substances | Individual impurity < 0.5%; Total impurities < 1.0% | HPLC |
| Calcium Content | 7.5 – 8.5% | ICP-OES / Titration |
| Solubility | Freely soluble in water | Ph. Eur. |
| Loss on Drying | ≤ 8.0% | USP <731> |
| Heavy Metals (Total as Pb) | ≤ 10 ppm | USP <231> / ICP-MS |
| Residual Solvents | Comply with ICH Q3C | GC-MS |
| Microbial Limits | Total Aerobic Count ≤ 1000 CFU/g; Absence of Pathogens | USP <61>, <62> |
| Shelf Life (in finished product) | 36 months (when stored properly) | ICH Q1A stability data |
Scientific Foundation: Why Active Folate Matters
The Folic Acid Conversion Bottleneck
Folic acid, the synthetic form found in many supplements and fortified foods, is not biologically active. It must be converted by the enzyme MTHFR (methylenetetrahydrofolate reductase) into L-5-MTHF.
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The MTHFR Challenge: Genetic variants (polymorphisms) in the MTHFR gene are extremely common, reducing enzymatic activity by 40-70% in a significant portion of the population. This creates a metabolic bottleneck, leading to unmetabolized folic acid in the bloodstream and inadequate supply of active folate where it’s needed.
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The SRBio Solution: By supplying L-5-MTHF directly, you bypass this genetic bottleneck entirely, ensuring 100% of users receive the full, intended physiological benefit.
Application-Specific Solutions
SRBio L-5-MTHF is the preferred choice for formulators targeting specific health outcomes with precision and reliability.
| Application | Mechanism & Benefit | SRBio Advantage |
|---|---|---|
| Prenatal & Women’s Health | Critical for neural tube development in the fetus; supports maternal red blood cell formation. | The only form that reliably raises red blood cell folate levels in all mothers, regardless of MTHFR status. |
| Cardiovascular Health | Acts as a methyl donor to convert homocysteine back to methionine, helping to maintain healthy homocysteine levels. | Direct activity ensures effective homocysteine modulation, even in individuals with impaired methylation. |
| Mental Health & Mood Support | Essential cofactor for the synthesis of neurotransmitters like serotonin, dopamine, and norepinephrine. | Active form readily crosses the blood-brain barrier to support mood, cognitive function, and emotional well-being. |
| Active Pharmaceutical Ingredients (API) | Used in specialty pharmaceuticals for the treatment of folate deficiency and metabolic disorders. | Meets strict >99% purity and low impurity requirements for pharmaceutical registration (DMF support available). |
| Food Fortification | Fortification of medical nutrition products, meal replacements, and staple foods. | Superior stability and solubility ensure consistent delivery and no impact on taste or texture. |
Technical Partnership Program: Beyond Supply
1. Co-Development & Customization Services
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Custom Particle Size Engineering: We can tailor particle size distribution (e.g., micronized grades) for optimized content uniformity in low-dose tablets or for specific dissolution profiles.
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Joint Application Development: Our R&D team collaborates with your formulators to troubleshoot challenges and optimize L-5-MTHF performance in your specific matrix (e.g., protecting stability in gummies or liquids).
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New Product Collaboration: Partner with us to develop next-generation formulations using our stabilized folate technology.
2. Regulatory & Market Entry Support
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Comprehensive Dossiers: Pre-built documentation packages to streamline your FDA, EMA, Health Canada, or TGA submissions. (FDA DMF # available upon request).
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Audit Support: We accommodate virtual and on-site audits with ready-to-share audit packages and full documentation transparency.
3. Supply & Logistics Partnership
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Flexible Terms: We offer various payment options (LC at sight, TT) and can structure extended terms for long-term, established partners.
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Rapid Response: A 24-hour technical response guarantee for any critical quality or supply chain issues.
Client Testimonials: The SRBio Supply Experience
*”SRBio has been our primary L-5-MTHF supplier for 3 years. Their reliability during global supply chain disruptions has been invaluable to our business continuity.”*
— Global Procurement Director, Multinational Supplement Company
“The technical documentation package provided by SRBio streamlined our FDA submission process significantly. Their regulatory expertise sets them apart.”
— Quality Assurance Manager, US Pharmaceutical Firm
“We switched to SRBio for both quality and cost reasons. The product consistency has been excellent, and their technical support helped us optimize our formulation.”
— R&D Director, European Nutraceutical Company
Partner with SRBio
Choose SRBio for your L-5-MTHF supply and gain a strategic partner committed to your success. We offer:
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Guaranteed supply continuity and supply chain security.
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Uncompromising quality standards backed by third-party certifications.
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Competitive total cost of ownership (average 20-30% cost savings).
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Strategic technical partnership from product development to market launch.
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Proven product performance with >99% purity and superior stability.
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Reliable global logistics with a 99.7% on-time delivery record.
Start Your Supplier Qualification Today:
📧 Email: admin@plantextractssr.com
📞 Phone / WhatsApp / WeChat: +86-13720408392
Request Your Evaluation Sample Kit:
We provide complimentary samples with complete documentation (CoA, technical data sheet, and allergen statement) for qualified potential partners.
