Mecobalamin
Mecobalamin (Methylcobalamin) Manufacturer | Active Vitamin B12 API Headline: Premium Mecobalamin (Methylcobalamin) Manufacturer | Active Vitamin B12 API (CAS: 13422-55-4) Sub-headline: JP/USP Standard | High Purity Red Crystals | Neuroprotective & Bioactive Form Unique Selling Proposition (USP): • Direct Bioactivity: The biologically active coenzyme form of Vitamin B12, requiring no metabolic conversion. • Neurological Support: Specifically targets peripheral nerve tissue regeneration. • Superior Stability: Advanced crystallization technology ensures potency throughout shelf life.
Introduction
Mecobalamin (Methylcobalamin), CAS No. 13422-55-4, is the neurologically active form of Vitamin B12. Unlike Cyanocobalamin (synthetic), Mecobalamin contains a methyl group that allows it to participate directly in methylation reactions in the body without needing conversion.
It appears as dark red crystals or crystalline powder. It is the preferred B12 form for pharmaceutical applications treating peripheral neuropathies (like diabetic neuropathy) and nutraceuticals focusing on energy, brain health, and homocysteine management.
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Keywords：
mecobalamin
vitamin
Functions
1.Peripheral Nerve Regeneration
• Mechanism: Promotes the synthesis of neuronal lipids and structural proteins.
• Action: Accelerates the repair of damaged nerve tissues (axonal regeneration) and improves nerve conduction velocity, making it a frontline therapy for diabetic neuropathy.
2.Homocysteine Reduction
• Mechanism: Cofactor for Methionine Synthase.
• Action: Converts toxic homocysteine into methionine. High homocysteine levels are a risk factor for cardiovascular disease and cognitive decline.
3.Red Blood Cell Formation
• Mechanism: Essential for nucleic acid synthesis in bone marrow.
• Action: Promotes the maturation of erythrocytes, preventing megaloblastic anemia.
Applications
1.Pharmaceutical Injections/Tablets
• Application: Treatment of peripheral neuropathy, megaloblastic anemia, and amyotrophic lateral sclerosis (ALS - investigational).
• Why it works: High bioavailability and direct uptake by nerve tissues.
2.Dietary Supplements
• Application: Sublingual tablets, lozenges, and energy shots.
• Why it works: "Methyl" B12 is marketed as the superior, "natural" form, appealing to consumers seeking better absorption than standard Cyanocobalamin.
3.Sleep Support
• Application: Circadian rhythm formulas.
• Why it works: Modulates melatonin secretion, helping to restore healthy sleep-wake cycles.
Flow Chart
1.Fermentation: Cultivation of Pseudomonas denitrificans or Propionibacterium shermanii to produce Cobalamin precursors.
2.Extraction: Cell lysis and centrifugation.
3.Methylation: Chemical conversion to Methylcobalamin using methylating agents.
4.Purification: Chromatography (column separation) to remove impurities and analogs.
5.Crystallization: Solvent-based crystallization to achieve the specific JP/USP polymorph.
6.Drying: Vacuum drying in the dark (light sensitive).
7.Sieving: Particle size control.
8.Packaging: Aluminum tins or pharmaceutical-grade LDPE bags inside drums (Light-proof).
Quality Standard of Lactoferrin
Product: Mecobalamin (JP XVII / USP Grade)
CAS: 13422-55-4
| Item | Specification | Result |
| Appearance | Dark red crystals or crystalline powder | Conforms |
| Assay (on dry basis) | 98.0% - 101.0% | 99.4% |
| Loss on Drying | ≤ 11.5% | 8.2% |
| Related Substances | Total ≤ 2.0% | 0.8% |
| Heavy Metals | ≤ 10 ppm | < 5 ppm |
| Acetone (Residual Solvent) | ≤ 5000 ppm | Conforms |
| Microbiology | TAMC < 1000 CFU/g | Conforms |
Method of Analysis of Lactoferrin
Test Method: UV-Vis Spectrophotometry / HPLC
• Assay (JP Method): Measured by UV absorption at specific wavelengths (266nm, 342nm, 522nm).
• Purity (HPLC): Used to detect related impurities like Hydroxocobalamin or Cyanocobalamin traces.
Reference Chromatogram of Lactoferrin Reference Substance
(Description)
A valid HPLC chromatogram for Mecobalamin shows a major peak at the characteristic retention time. Crucially, the "Total Impurities" area must be low, showing clear separation from degradation products caused by light exposure.
Stability and Safety
Stability Studies
• Light Sensitivity: Extremely sensitive to light. Photolysis occurs rapidly, converting it to Hydroxocobalamin (turning color from red to pink/orange).
• Hygroscopicity: Moderately hygroscopic.
• Shelf Life: 24 to 36 Months if stored in original, unopened, light-proof containers.
Safety & Handling (MSDS Summary)
• Classification: Non-hazardous.
• Handling: Protect from light at all times during weighing and processing. Use amber glassware or red-light rooms if possible.
• Storage: Store in a cool, dry place, protected from light. Recommended storage temperature < 25°C.
Customer Comments
R&D Manager, NeuroHealth Labs (USA)
2026.04.03
★★★★☆
Quality Director, PharmaSynth (Japan)
2026.04.03
★★★★☆
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FAQ
What is the difference between Mecobalamin and Cyanocobalamin?
Mecobalamin is the natural, active form found in the body. Cyanocobalamin is synthetic and must be converted by the liver (releasing a cyanide molecule) to be used. Mecobalamin has better retention in tissues.
Is it vegan?
Yes, our Mecobalamin is produced via microbial fermentation and is 100% vegetarian/vegan friendly.
Why is the moisture content specification so high (≤11.5%)?
Mecobalamin crystals naturally hold water in their lattice structure. The JP/USP standard allows for this specific hydration level; it does not indicate "wet" product but rather bound water.
References
1.Zhang, M., et al. (2013). "Methylcobalamin: A Potential Vitamin of Pain Killer." Neural Plasticity.
2.Yagihashi, S., et al. (1982). "In vivo effect of methylcobalamin on the peripheral nerve structure in streptozotocin diabetic rats." Horm. Metab. Res.
3.Kelly, G. (1997). "The Coenzyme Forms of Vitamin B12: Toward an Understanding of their Therapeutic Potential." Alternative Medicine Review.
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