Hydroxocobalamin
Hydroxocobalamin Manufacturer | Premium Vitamin B12 API & Antidote Headline: Hydroxocobalamin API Manufacturer | High Retention Vitamin B12 (CAS: 13422-51-0) Sub-headline: EP/USP Grade | Cyanide Antidote Precursor | Long-Acting B12 Form Unique Selling Proposition (USP): • Superior Retention: Binds more tightly to plasma proteins than Cyanocobalamin, ensuring sustained B12 levels in the body. • Detoxification Power: The specific form used as a rapid antidote for cyanide poisoning. • Pharmaceutical Purity: Manufactured under strict GMP guidelines to meet injectable standards (Hydroxocobalamin Acetate/Chloride/Sulfate).
Introduction
Hydroxocobalamin (Vitamin B12b), CAS No. 13422-51-0, is a natural and highly bioactive form of Vitamin B12 produced by bacteria. Unlike Cyanocobalamin, it does not contain a cyanide group; instead, it has a hydroxyl group attached to the cobalt ion.
This unique structure allows it to react readily with cyanide in the body to form harmless Cyanocobalamin, making it the first-line medical treatment for cyanide poisoning. Additionally, due to its longer half-life and better tissue retention, it is the preferred B12 form for high-dose injectable therapies to treat pernicious anemia and B12 deficiency.
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Keywords：
hydroxocobalamin
retention
Functions
1.Cyanide Detoxification
• Mechanism: The cobalt ion in Hydroxocobalamin has a high affinity for cyanide ions.
• Action: It rapidly binds circulating cyanide to form stable, non-toxic Cyanocobalamin, which is then excreted in urine. This life-saving mechanism is used in emergency medicine (smoke inhalation treatment).
2.Long-Lasting B12 Supply
• Mechanism: High binding affinity to serum proteins (transcobalamins).
• Action: It is excreted more slowly by the kidneys compared to Cyanocobalamin, providing elevated serum B12 levels for a longer duration, reducing the frequency of injections required for patients.
3.Homocysteine Metabolism
• Mechanism: Converts to Methylcobalamin in the cell.
• Action: Participates in the remethylation of homocysteine to methionine, supporting cardiovascular and neurological health.
Applications
1.Pharmaceutical Injectables (Primary)
• Application: "Depot" B12 injections and Cyanokit®-type antidotes.
• Why it works: Its stability and retention profile make it the gold standard for therapeutic B12 correction and emergency toxicology.
2.Dietary Supplements
• Application: Sublingual drops and lozenges.
• Why it works: Often marketed as a "cleaner" B12 (cyanide-free) for health-conscious consumers who prefer natural forms over synthetic Cyanocobalamin.
3.Transdermal Patches
• Application: B12 energy patches.
• Why it works: Its molecular stability supports transdermal delivery systems.
Flow Chart
1.Fermentation: Controlled fermentation using specialized bacterial strains (e.g., Pseudomonas denitrificans).
2.Harvesting: Separation of cellular biomass.
3.Conversion: Careful processing to maintain the hydroxyl ligand (avoiding cyanidation).
4.Purification: Chromatography to remove impurities and analogues.
5.Salt Formation: Conversion to Hydroxocobalamin Acetate, Chloride, or Sulfate depending on the target pharmacopeia (EP vs USP).
6.Crystallization: Formation of dark red crystals.
7.Drying: Low-temperature vacuum drying.
8.Packaging: Glass vials or aluminum tins (sterile conditions for API).
Quality Standard of Lactoferrin
Product: Hydroxocobalamin Acetate / Chloride (EP/USP)
CAS: 13422-51-0
| Item | Specification | Result |
| Appearance | Dark red crystals or powder | Conforms |
| Assay (on dry basis) | 96.0% - 102.0% | 99.1% |
| pH | 8.0 - 10.0 | 9.2 |
| Loss on Drying | ≤ 12.0% | 8.5% |
| Related Substances | Total ≤ 5.0% | 2.1% |
| Coloured Impurities | ≤ 3.0% | 1.5% |
| Heavy Metals | ≤ 20 ppm | < 10 ppm |
| Bacterial Endotoxins | < 0.25 EU/mg (for injection) | Conforms |
Method of Analysis of Lactoferrin
Test Method: UV-Vis Spectrophotometry & HPLC
• Identity: UV absorption spectrum exhibits maxima at specific wavelengths (e.g., 274 nm, 351 nm, 525 nm). The ratio of absorbance values confirms the identity.
• Purity: HPLC is essential to separate Hydroxocobalamin from its degradation products and other corrinoids.
Reference Chromatogram of Lactoferrin Reference Substance
(Description)
The HPLC profile will show the main Hydroxocobalamin peak. Critical attention is paid to the "Coloured Impurities" section, ensuring separation from Cyanocobalamin (which might be present as a trace impurity) and other oxidation products.
Stability and Safety
Stability Studies
• Photosensitivity: Like all B12s, it is light-sensitive. Prolonged exposure leads to degradation.
• Thermal Stability: Relatively stable in solid form but heat-sensitive in solution.
• Shelf Life: 36 Months when stored in strictly light-protected, cool conditions (< 25°C).
Safety & Handling (MSDS Summary)
• Classification: Non-hazardous.
• Handling: Avoid contact with skin (causes temporary red staining). Wear gloves and eye protection.
• Storage: Protect from light. Store in tight, light-resistant containers.
Customer Comments
Production Pharmacist, EuroInject (Belgium)
2026.04.07
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2026.04.07
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FAQ
What is the difference between Hydroxocobalamin Acetate, Chloride, and Sulfate?
They are different salt forms. Hydroxocobalamin Acetate and Chloride are most commonly used in pharmaceuticals (EP/USP). The choice depends on the specific formulation requirements and regional pharmacopoeia preference.
Does it require cold chain transport?
While it is stable at room temperature for short periods, we recommend cool transport and strictly light-protected shipping to ensure maximum potency upon arrival.
Is it suitable for smokers?
Yes. Smokers often have higher levels of cyanide in their blood. Taking Hydroxocobalamin helps detoxify this cyanide, whereas taking Cyanocobalamin would add a small amount of cyanide (though usually negligible), making Hydroxo- the preferred choice for this demographic.
References
1.Hall, A.H., et al. (1987). "Hydroxocobalamin for acute cyanide poisoning." American Journal of Emergency Medicine.
2.Forsyth, J.C., et al. (1993). "Hydroxocobalamin as a cyanide antidote: safety, efficacy and pharmacokinetics in heavily smoking normal volunteers." Clinical Toxicology.
3.Chui, et al. (1993). "Absorption of Hydroxocobalamin." Journal of Pharmacy and Pharmacology.
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