Hydroxocobalamin Acetate
Hydroxocobalamin Acetate Manufacturer | Pharmaceutical Grade B12 Headline: Premium Hydroxocobalamin Acetate Manufacturer | High Purity Vitamin B12b (CAS: 22465-48-1 / 13422-51-0) Sub-headline: EP/USP Standard | Dark Red Crystals | Essential for Sterile Injectables Unique Selling Proposition (USP): • Pharmaceutical Compliance: Produced strictly according to EP/USP monographs, ensuring low endotoxin and impurity levels. • Injectable Grade: High solubility and stability profile, specifically designed for liquid pharmaceutical formulations. • Cyanide-Free: The preferred "natural" B12 form for detoxification therapies and sensitive patient groups.
Introduction
Hydroxocobalamin Acetate is the acetate salt form of Hydroxocobalamin (Vitamin B12b). While the base CAS 13422-51-0 is often used generally, the specific acetate salt is critical for pharmaceutical stability.
It appears as dark red, odorless crystals. Compared to the hydrochloride salt, the acetate form is often preferred in specific formulation pH ranges to maintain stability. It serves as a potent, long-acting source of Vitamin B12, widely used in the treatment of pernicious anemia, cyanide poisoning (antidote), and tobacco amblyopia.
Category：
Keywords：
acetate
hydroxocobalamin
pharmaceutical
Functions
1.Sustained B12 Release
• Mechanism: Exhibits high binding affinity to plasma transport proteins (Transcobalamin II).
• Action: Remains in the bloodstream significantly longer than Cyanocobalamin, reducing the injection frequency needed to maintain therapeutic serum B12 levels.
2.Cyanide Antidote Activity
• Mechanism: The central cobalt ion binds directly to toxic cyanide ions to form harmless Cyanocobalamin.
• Action: It is the active ingredient in emergency "Cyanokits" used for smoke inhalation victims and industrial cyanide exposure.
3.Neurological Protection
• Mechanism: Acts as a cofactor for Methylmalonyl-CoA mutase.
• Action: Prevents the accumulation of methylmalonic acid (MMA), which causes myelin sheath degeneration, thereby protecting nerve function.
Applications
1.Sterile Injectables (Main Use)
• Application: Intramuscular or intravenous injections.
• Why it works: Its high purity and specific salt form allow for stable aqueous solutions required for hospital-grade ampoules.
2.Oral Supplements
• Application: High-end B12 lozenges and capsules.
• Why it works: Marketed as a premium, bioactive, and "clean" (cyanide-free) B12 source.
3.Ophthalmic Solutions
• Application: Eye drops.
• Why it works: Used in formulations supporting eye health, particularly for relieving visual fatigue (often combined with other B vitamins).
Flow Chart
1.Fermentation: Microbial biosynthesis of Cobalamin.
2.Isolation: Extraction of the cobalamin fraction.
3.Salt Conversion: Reaction with Acetic Acid under controlled conditions to form the Acetate salt.
4.Chromatography: High-performance purification to remove related substances (impurities).
5.Crystallization: Formation of the specific crystal lattice.
6.Lyophilization (Freeze Drying): Optional step for high-end injectable grades to ensure instant solubility.
7.Sieving & Packaging: In a cleanroom environment (Class D or higher).
8.Storage: Sealed in light-resistant aluminum containers.
Quality Standard of Lactoferrin
Product: Hydroxocobalamin Acetate (EP / USP)
CAS: 13422-51-0 (General) / 22465-48-1 (Specific)
| Item | Specification | Result |
| Appearance | Dark red crystals or powder | Conforms |
| Assay (on dry basis) | 96.0% - 102.0% | 99.3% |
| pH (2% solution) | 8.0 - 10.0 | 8.9 |
| Acetic Acid Content | 4.0% - 8.0% | 6.2% |
| Loss on Drying | ≤ 12.0% | 7.8% |
| Related Substances | Total ≤ 5.0% | 1.8% |
| Bacterial Endotoxins | < 0.25 EU/mg | Conforms |
| Microbial Limit | Sterile / Low Bioburden | Conforms |
Method of Analysis of Lactoferrin
Test Method: HPLC (High-Performance Liquid Chromatography)
• Assay: Quantified against a certified reference standard.
• Acetic Acid: Verified via titration or HPLC to ensure the correct salt stoichiometry.
• Impurities: Strictly monitored to ensure separation from Cyanocobalamin and other corrinoids.
Reference Chromatogram of Lactoferrin Reference Substance
(Description)
The chromatogram displays a dominant peak for Hydroxocobalamin. The Acetate ion (counter-ion) does not absorb in the same UV region but is quantified separately. The impurity profile must show a clean baseline, critical for injectable safety.
Stability and Safety
Stability Studies
• Hygroscopicity: Hydroxocobalamin Acetate is hygroscopic. It must be handled in low-humidity environments.
• Light Sensitivity: High. Exposure to light causes rapid degradation. Manufacturing and packaging must be done under red light.
• Shelf Life: 36 Months in unopened, original packaging (Aluminum tin/drum).
Safety & Handling (MSDS Summary)
• Classification: Non-hazardous API.
• Handling: Prevent dust inhalation. Avoid contact with skin (staining).
• Storage: Store at 2°C - 8°C (Refrigerated) recommended for long-term storage, or cool room temperature (<25°C) if strictly light-protected.
Customer Comments
Procurement Manager, Antidote Pharma (Switzerland)
2026.04.01
★★★★☆
R&D Director, Injecta Solutions (India)
2026.04.01
★★★★☆
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FAQ
What is the main difference between Acetate and Chloride salts?
Both are forms of Hydroxocobalamin. The Acetate salt is often preferred for specific buffering capacities in liquid formulations, while the Chloride salt is standard in others. Both are pharmacologically equivalent in terms of B12 activity.
Can this be used for oral supplements?
Yes, absolutely. It is a premium form for oral use, offering a "clean label" (no cyanide) claim.
How do you ensure the product is cyanide-free?
We use a dedicated production line that does not handle Cyanocobalamin, preventing any cross-contamination. Our HPLC testing confirms the absence of the Cyanocobalamin peak.
References
1.Rizzo, G., et al. (2016). "Vitamin B12 among Vegetarians: Status, Assessment and Supplementation." Nutrients.
2.Shepherd, G., et al. (2005). "Hydroxocobalamin as a cyanide antidote." Annals of Pharmacotherapy.
3.European Pharmacopoeia (Ph. Eur.) Monograph: Hydroxocobalamin Acetate.
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