Product Overview
L-5-methyltetrahydrofolate glucosamine salt is the fourth‑generation active folate and represents the most advanced, physiologically native form of folate available for dietary supplements, pharmaceuticals, prenatal nutrition, and functional foods. It is the predominant circulating form of folate in human plasma and the only folate derivative capable of crossing the blood‑brain barrier to support central nervous system health.
Unlike traditional synthetic folic acid, which requires multi‑step enzymatic activation in the liver via the MTHFR enzyme, L-5-methyltetrahydrofolate glucosamine salt is already biologically active and can be directly utilized by cells upon absorption. This eliminates metabolic bottlenecks, prevents the accumulation of unmetabolized folic acid (UMFA), and ensures consistent efficacy even in individuals with genetic MTHFR polymorphisms.
As a primary methyl donor in one‑carbon metabolism, this ingredient supports DNA synthesis and repair, healthy cell division, fetal neurodevelopment, homocysteine balance, cognitive function, red blood cell formation, and cardiovascular health.
SRBio L-5-methyltetrahydrofolate glucosamine salt is manufactured using proprietary chiral purification technology under strict cGMP and pharmaceutical‑grade conditions. Our product guarantees ultra‑high (6S)‑isomer purity, exceptional stability, low hygroscopicity, and full compliance with global regulatory standards including USP, EP, JP, and EU Novel Food requirements.
Detailed Product Specifications
| Parameter | SRBio Standard | Test Method | Industry Norm | Advantage Description |
|---|---|---|---|---|
| Product Name | L-5-methyltetrahydrofolate glucosamine salt | HPLC + Chiral HPLC | L-5-methyltetrahydrofolate glucosamine salt | Confirmed active folate structure; no inactive analogs |
| CAS Number | 1181972-37-1 | Standard Reference Database | 1181972-37-1 | Fully registered and compliant with global regulatory databases |
| Molecular Formula | C₂₆H₃₈N₈O₁₁ | Elemental Analysis & NMR | Standard Formula | Consistent molecular composition with no structural deviations |
| Molecular Weight | 638.63 g/mol | HPLC & Mass Spectrometry | Standard Molecular Weight | Precise molecular identification for quality assurance |
| Appearance | Light yellow to off‑white crystalline powder | Visual & Microscopic Analysis | Pale crystalline powder | Uniform particle color; no dark spots or foreign impurities |
| Assay (Dried Basis) | 34% – 36% | HPLC‑UV | 34.0% – 36.0% (或 35.0% ± 1.0%) | Tighter assay range ensures accurate dosing in finished products |
| Related Substances | Total impurities ≤1.0%; single impurity ≤0.5% | HPLC | Total impurities ≤2.0% | Ultra‑clean profile ideal for pharma and prenatal applications |
| Loss on Drying | ≤5.0% | Gravimetric Drying Method | ≤6.0% | Low moisture improves stability and reduces caking |
| Heavy Metals | As <0.1 ppm; Pb <0.05 ppm; Hg <0.01 ppm; Cd <0.01 ppm | ICP‑MS | ≤10 ppm total | Far below USP/EP/FCC limits; safe for long‑term and prenatal use |
| Residual Solvents | Class 1 & 2 Solvents: Not Detected (ND) | GC‑Headspace | ≤500 ppm | Solvent‑free production; clean‑label compliant |
| Microbiological Limits | Total plate count <100 CFU/g; Yeast/Mold <10 CFU/g; E. coli, Salmonella, Staphylococcus aureus: Negative | USP <61> & <62> | Standard food/pharma limits | Suitable for direct human consumption and sterile formulations |
| pH (1% Aqueous Solution) | 5.0 – 7.5 | pH Meter | 4.5 – 8.0 | Compatible with softgels, tablets, liquids, and powder blends |
| Solubility | Soluble in water; slightly soluble in methanol; insoluble in acetone/ether | USP Solubility Test | Standard solubility | Excellent for aqueous formulations, drinks, and oral suspensions |
| Particle Size | 40–100 mesh (customizable upon request) | Laser Diffraction Analysis | Variable | Optimized flowability for high‑speed tableting and encapsulation |
| Packaging | 1kg / 5kg aluminum foil bag; 25kg fiber drum; moisture‑proof, light‑proof, oxygen‑barrier | Packaging Stability Test | Industry standard | Protects against oxidation, humidity, and photodegradation |
| Storage Condition | Sealed, kept in dry and cool place; recommended 2–8°C for long‑term storage | Accelerated Stability (ICH Q1A) | Room temperature or refrigerated | Extended shelf life with proper cold‑chain support |
| Shelf Life | 24 months (unopened, refrigerated) | Real‑time stability study | 18–24 months | Longer shelf life reduces inventory loss and retesting costs |
Key Scientific Facts
L-5-methyltetrahydrofolate glucosamine salt vs. Synthetic Folic Acid
Synthetic folic acid (pteroylmonoglutamic acid) is biologically inactive and requires conversion by dihydrofolate reductase (DHFR) and MTHFR enzymes in the liver. Many individuals — especially those with MTHFR C677T or A1298C polymorphisms — experience reduced conversion efficiency, leading to unmetabolized folic acid (UMFA) accumulation.
L-5-methyltetrahydrofolate glucosamine salt:
- Requires no enzymatic activation
- Is directly absorbed and utilized
- Avoids UMFA buildup
- Maintains consistent physiological activity
- Works effectively regardless of MTHFR genotype
Evolution of Folic Acid Supplements
1st Generation: Folic Acid — synthetic, inactive, enzyme‑dependent
2nd Generation: Calcium Folinate (Leucovorin) — partially active, low stability
3rd Generation: L‑5‑Methyltetrahydrofolate Calcium — chiral active, moderate stability
4th Generation: L-5-methyltetrahydrofolate glucosamine salt — highest stability, best solubility, superior bioavailability, gentler on gastric mucosa
Synergistic Nutrient Partners
L-5-methyltetrahydrofolate glucosamine salt functions optimally when combined with:
- Vitamin B12 (methylcobalamin)
- Vitamin B6 (pyridoxal‑5‑phosphate)
- Betaine (trimethylglycine)
- Magnesium
- DHA & omega‑3 fatty acids
- Iron
- Iodine
These combinations enhance homocysteine regulation, neurodevelopment, and cellular methylation.
Why Choose SRBio L-5-methyltetrahydrofolate glucosamine salt?
1. Ultra-High Chiral Purity & Pharmaceutical Safety
- ≥99.5% (6S)‑isomer — the only biologically active form
- Near‑zero (6R)‑isomer, which can interfere with cellular folate receptors
- Heavy metal levels meet injectable‑grade specifications
- Non‑GMO, gluten‑free, soy‑free, dairy‑free, nut‑free, allergen‑free
- Full batch traceability via QR code with complete COA, HPLC, and ICP‑MS reports
2. Superior Stability & Formulation Performance
- Significantly more stable than L‑5‑Methyltetrahydrofolate Calcium
- Low hygroscopicity; resists clumping even in high‑humidity environments
- Excellent compatibility with multivitamins, minerals, and herbal extracts
- Suitable for tablets, capsules, softgels, powders, oral liquids, and gummies
- Does not degrade rapidly in acidic or neutral formulations
3. Advanced Production & Strict Quality Control
- Proprietary chiral synthesis and crystallization technology
- Class 100,000 cleanroom for drying, milling, and packaging
- Real‑time HPLC and chiral testing every 2 hours during production
- In‑house lab equipped with HPLC, ICP‑MS, GC, LAL, and microbial systems
- Fully compliant with cGMP, FSSC 22000, ISO 22000, USP, EP, and JP
4. Clinical Relevance & Global Regulatory Acceptance
- Approved for use in dietary supplements, pharmaceuticals, and prenatal products
- Recognized in EU, US, Canada, Japan, Australia, and Southeast Asia
- Supported by numerous clinical studies on safety, bioavailability, and efficacy
- Ideal for populations with compromised folate metabolism (e.g., elderly, pregnant women, MTHFR variants)
Science-Supported Physiological Functions
Supports Healthy Homocysteine Metabolism
- Acts as the primary methyl donor for homocysteine remethylation
- Works synergistically with B12 and B6 to maintain normal homocysteine levels
- Supports cardiovascular and cerebrovascular health
- Helps maintain endothelial function and vascular elasticity
Fetal Neurodevelopment & Maternal Health
- Critical for neural tube formation and early embryonic development
- Supports healthy spinal cord, brain, and placental cell division
- Reduces dependence on liver enzyme function
- Safe and preferred for preconception, pregnancy, and lactation
Cognitive & Neurological Health
- Crosses the blood‑brain barrier efficiently
- Supports neurotransmitter production and myelin maintenance
- Promotes neuronal health, memory, focus, and cognitive clarity
- Beneficial for aging populations concerned with mental performance
DNA Synthesis, Cell Renewal & Hematological Health
- Essential for purine and pyrimidine biosynthesis
- Supports normal DNA replication and repair
- Promotes healthy red blood cell maturation
- Maintains mucosal integrity and rapid cellular turnover
Methylation Cycle Support
- Fuels the body’s universal methylation pathway
- Supports gene expression, detoxification, and hormone metabolism
- Helps maintain healthy epigenetic regulation
Recommended Dosage Guidelines
- Adult daily maintenance: 400 – 800 μg/day
- Preconception & pregnancy: 400 – 800 μg/day (per regional health authority guidelines)
- Homocysteine support: 800 – 5000 μg/day (under professional supervision)
- Geriatric cognitive support: 800 – 1500 μg/day
- Safe for long‑term daily use within labeled dosage ranges
Application-Specific Solutions
Prenatal & Maternal Nutrition
- Core ingredient in prenatal multivitamins
- High bioavailability for mothers with MTHFR variations
- Gentle, non‑irritating formulation profile
- Stable in softgels and tablets
Cardiovascular Health Formulas
- Key component in homocysteine‑lowering blends
- Synergistic with B6, B12, betaine, and magnesium
- Long shelf stability in capsule and tablet forms
Cognitive & Brain Health Supplements
- Ideal for nootropic, memory, and focus formulations
- Compatible with PS, CoQ10, PQQ, omega‑3s, and green tea extract
- Supports neuroprotection and mitochondrial function
General Multivitamins & Functional Foods
- Suitable for tablets, powders, RTD drinks, and gummies
- Premium “fourth‑generation folate” marketing positioning
- Clean‑label, high‑purity appeal for health‑conscious consumers
Pharmaceutical Formulations
- Meets USP/EP/JP standards
- Low‑endotoxin grade available
- Used in prescription folate deficiencies and neurological support
Global Certifications & Compliance
- cGMP Certified
- ISO 22000
- FSSC 22000
- USP / EP / JP Compliant
- GRAS Self‑Affirmed
- EU Novel Food Dossier Ready
- Non‑GMO Verified
- Allergen‑Free Certified
- Vegan & Vegetarian Friendly
- Halal & Kosher Available Upon Request
Customer Support & Supply Chain
- Free 50g / 500g samples delivered within 72 hours
- Full COA, TDS, MSDS, and chiral chromatograms provided
- Custom particle sizes, blends, and dosage forms available
- Stability testing and formulation compatibility support
- Global logistics with cold‑chain options for long‑distance shipments
- Dedicated regulatory team for market entry in US, EU, APAC, and Middle East
Contact & Sample Request
Request your pharma‑grade L-5-methyltetrahydrofolate glucosamine salt sample today to experience superior purity, stability, and bioavailability. Our technical and regulatory team provides full support to accelerate your product development and global launch.
Shipping & Packing Information
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.
