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Hydroxocobalamin | CAS No: 13422-51-0 | GMP-certified suppliers
A medication that supports treatment of pernicious anemia and diverse vitamin B12 deficiency states while providing established emergency use for known or suspected cyanide poisoning.
Therapeutic categories
Primary indications
- For treatment of pernicious anemia and the prevention and treatment of vitamin B12 deficiency arising from alcoholism, malabsorption, tapeworm infestation, celiac, hyperthyroidism, hepatic-biliary tract disease, persistent diarrhea, ileal resection, pancreatic cancer, renal disease, prolonged stress, vegan diets, macrobiotic diets or other restrictive diets
- Also for the treatment of known or suspected cyanide poisoning
Product Snapshot
- Hydroxocobalamin is available as injectable and oral vitamin B12 formulations including solutions, powders for solution, and tablets
- It is used for pernicious anemia, vitamin B12 deficiency from varied malabsorption or dietary causes, and for known or suspected cyanide poisoning
- It is approved in major regulated markets including the US, Canada, and the EU
Clinical Overview
Pharmacologically, hydroxocobalamin serves as a precursor to the active cobalamin cofactors methylcobalamin and adenosylcobalamin. These cofactors support essential metabolic pathways related to nucleic acid synthesis, hematopoiesis, and myelin integrity. Through replenishment of functional vitamin B12 pools, the drug helps correct impaired DNA synthesis, abnormal erythrocyte maturation, and neurological manifestations arising from deficiency.
The mechanism of action centers on its role as a coenzyme. Methylcobalamin is required by methionine synthase to convert homocysteine to methionine, a precursor necessary for folate-dependent DNA synthesis and methylation reactions. Adenosylcobalamin functions as a cofactor for the conversion of L‑methylmalonyl‑CoA to succinyl‑CoA, a step integral to energy extraction from fats and proteins and to hemoglobin synthesis. These pathways explain the hematologic and neurologic consequences observed in deficiency states.
Absorption following parenteral administration is high, with wide tissue distribution including hepatic storage. Hydroxocobalamin circulates bound to transcobalamins and is ultimately eliminated renally, largely as intact cobalamin and metabolites. The safety profile is generally well characterized; adverse effects may include transient chromaturia, injection-site reactions, and dose‑related increases in blood pressure when used for cyanide toxicity. High doses used in antidotal therapy can transiently interfere with certain laboratory assays due to its strong chromophore.
Hydroxocobalamin is available in various parenteral formulations, including products used internationally for B12 replacement and cyanide antidote kits.
For API procurement, manufacturers should verify cobalamin identity, cobalt content, and impurity limits, with attention to photostability, proper handling under controlled light conditions, and compliance with pharmacopeial specifications relevant to the intended market.
Identification & chemistry
| Generic name | Hydroxocobalamin |
|---|---|
| Molecule type | Small molecule |
| CAS | 13422-51-0 |
| UNII | Q40X8H422O |
| DrugBank ID | DB00200 |
Pharmacology
| Summary | Hydroxocobalamin functions as a precursor to active cobalamin cofactors that support one‑carbon transfer reactions and mitochondrial metabolism. Its primary targets include methionine synthase and methylmalonyl‑CoA mutase, which regulate homocysteine remethylation, DNA methylation capacity, and conversion of methylmalonyl‑CoA to succinyl‑CoA. These actions support nucleic acid synthesis, hematopoiesis, and myelin maintenance through effects on folate and lipid metabolism. |
|---|---|
| Mechanism of action | Vitamin B12 exists in four major forms referred to collectively as cobalamins; deoxyadenosylcobalamin, methylcobalamin, hydroxocobalamin, and cyanocobalamin. Two of these, methylcobalamin and 5-deoxyadenosyl cobalamin, are primarily used by the body. Methionine synthase needs methylcobalamin as a cofactor. This enzyme is involved in the conversion of the amino acid homocysteine into methionine. Methionine in turn is required for DNA methylation. 5-Deoxyadenosyl cobalamin is a cofactor needed by the enzyme that converts L-methylmalonyl-CoA to succinyl-CoA. This conversion is an important step in the extraction of energy from proteins and fats. Furthermore, succinyl CoA is necessary for the production of hemoglobin, the substances that carries oxygen in red blood cells. |
| Pharmacodynamics | Hydroxocobalamin is a synthetic, injectable form of Vitamin B12. Hydroxocobalamin is actually a precursor of two cofactors or vitamins (Vitamin B12 and Methylcobalamin) which are involved in various biological systems in man. Vitamin B12 is required for the conversion of methylmalonate to succinate. Deficiency of this enzyme could therefore interfere with the production of lipoprotein in myelin sheath tissue and so give rise to neurological lesions. The second cofactor, Methylcobalamin, is necessary for the conversion of homocysteine to methionine which is essential for the metabolism of folic acid. Deficiency of tetrahydrafolate leads to reduced synthesis of thymidylate resulting in reduced synthesis of DNA which is essential for cell maturation. Vitamin B12 is also concerned in the maintenance of sulphydryl groups in reduced form, deficiency leading to decreased amounts of reduced SH content of erythrocytes and liver cells. Overall, vitamin B12 acts as a coenzyme for various metabolic functions, including fat and carbohydrate metabolism and protein synthesis. It is necessary for growth, cell replication, hematopoiesis, and nucleoprotein as well as myelin synthesis. This is largely due to its effects on metabolism of methionine folic acid, and malonic acid. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Methionine synthase | Humans | cofactor |
| Methylmalonyl-CoA mutase, mitochondrial | Humans | cofactor |
| Methylmalonic aciduria type A protein, mitochondrial | Humans | other/unknown |
ADME / PK
| Absorption | Readily absorbed from the gastrointestinal tract, except in malabsorption syndromes. Vitamin B12 is absorbed in the lower half of the ileum. |
|---|---|
| Half-life | Approximately 6 days (peak plasma concentration after 8-12 hours from oral administration) |
| Protein binding | Very high (90%). Cobalamins are extensively bound to two specific plasma proteins called transcobalamin 1 and 2; 70% to transcobalamin 1, 5% to transcobalamin 2. |
| Metabolism | Primarily hepatic. Cobalamins are absorbed in the ileum and stored in the liver. They continuously undergo enterohepatic recycling via secretion in the bile. Part of a dose is excreted in the urine, most of it in the first 8 hours. |
| Route of elimination | Each hydroxocobalamin molecule can bind one cyanide ion by substituting it for the hydroxo ligand linked to the trivalent cobalt ion, to form cyanocobalamin, which is then excreted in the urine. |
Formulation & handling
- Hydroxocobalamin is a highly water‑soluble cobalamin derivative used mainly in parenteral formulations, with oral forms relying on facilitated GI absorption mechanisms typical of vitamin B12 analogs.
- Lyophilized intravenous powders require reconstitution with aqueous diluents and protection from light due to cobalamin photosensitivity.
- The large molecular weight and hydrophilic profile favor solution-based injectables, with stability influenced by pH and susceptibility to degradation under strong light or oxidative conditions.
Regulatory status
| Lifecycle | The active ingredient’s US patent expired in 2016, indicating that it is well past exclusivity. With products marketed in the US, Canada, and the EU, the market is mature and likely characterized by established generic competition. |
|---|
| Markets | US, Canada, EU |
|---|
Supply Chain
| Supply chain summary | Multiple manufacturers supply hydroxocobalamin, with several companies involved in both API production and finished‑dose packaging. Branded products such as Cyanokit are marketed across the US, Canada, and the EU, indicating a broad global presence. The key US patent expired in 2016, suggesting that generic competition is already possible and may be established in some markets. |
|---|
Hydroxocobalamin is a type of Vitamins
Vitamins are an essential subcategory of pharmaceutical Active Pharmaceutical Ingredients (APIs) that play a crucial role in maintaining optimal health and well-being. These organic compounds are required in small quantities by the human body to support various metabolic processes and ensure proper functioning of bodily systems. Vitamins can be broadly classified into two groups: fat-soluble vitamins (such as vitamins A, D, E, and K) and water-soluble vitamins (including vitamin C and B-complex vitamins). Each vitamin has a specific role and function within the body.
Pharmaceutical APIs in the vitamin subcategory are carefully synthesized or extracted to meet stringent quality standards and ensure purity, efficacy, and safety. They are used as active ingredients in the formulation of various pharmaceutical products, including dietary supplements, fortified foods, and pharmaceutical formulations.
Vitamin APIs are commonly utilized in the pharmaceutical industry for their therapeutic benefits. For instance, vitamin D API is widely prescribed to treat deficiencies and maintain optimal bone health, while vitamin C API is utilized for its antioxidant properties and immune-boosting effects. B-complex vitamins, such as vitamin B12 API, are essential for energy production and nerve function.
Overall, vitamins are integral to maintaining good health, and pharmaceutical APIs in this subcategory play a vital role in providing these essential nutrients to individuals through various pharmaceutical and dietary applications.
Hydroxocobalamin (Vitamins), classified under Therapeutic Nutrients/Minerals/Electrolyte
Therapeutic Nutrients/Minerals/Electrolytes: A Comprehensive Technical DescriptionTherapeutic nutrients, minerals, and electrolytes are a vital category of pharmaceutical active pharmaceutical ingredients (APIs) used to support and enhance overall health and well-being. These compounds play a crucial role in maintaining the body's physiological balance, aiding in various metabolic processes, and addressing specific deficiencies.
Therapeutic nutrients encompass a broad range of substances, including vitamins, minerals, and electrolytes. Vitamins are organic compounds required in small quantities for proper bodily functions and are essential for growth, development, and disease prevention. Minerals, on the other hand, are inorganic substances that support numerous physiological processes, such as bone formation, nerve function, and energy production.
Electrolytes are minerals that carry an electric charge when dissolved in bodily fluids, including sodium, potassium, calcium, magnesium, and chloride. They play a crucial role in maintaining proper hydration, nerve impulses, muscle contractions, and pH balance.
Pharmaceutical APIs in the Therapeutic Nutrients/Minerals/Electrolyte category are designed to address specific deficiencies or imbalances in the body. These APIs are often used in the formulation of dietary supplements, nutritional products, and therapeutic treatments. They are manufactured under stringent quality control guidelines to ensure purity, potency, and bioavailability.
Therapeutic nutrients/minerals/electrolytes APIs are available in various forms, including tablets, capsules, powders, and liquid formulations. They are formulated to meet specific dosage requirements and can be combined with other ingredients for targeted health benefits.
Overall, therapeutic nutrients, minerals, and electrolytes APIs are essential components in maintaining optimal health. Their use helps address deficiencies, support bodily functions, and promote overall well-being. Pharmaceutical companies and healthcare professionals rely on these high-quality APIs to develop effective and safe products that contribute to a healthier population.
Hydroxocobalamin API manufacturers & distributors
Compare qualified Hydroxocobalamin API suppliers worldwide. We currently have 5 companies offering Hydroxocobalamin API, with manufacturing taking place in 3 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Apollo Healthcare Resourc... | Distributor | Singapore | Singapore | BSE/TSE, CEP, CoA, EDMF/ASMF, FDA, GMP, ISO9001, JDMF, KDMF, MSDS, USDMF, WC | 200 products |
| Changzhou Comwin Fine Che... | Producer | China | China | CoA | 235 products |
| Chr. Olesen Group | Distributor | Denmark | China | CEP, CoA, GMP, MSDS, USDMF | 252 products |
| Hebei Huarong | Producer | China | China | CoA, USDMF | 4 products |
| Sanofi | Producer | France | Unknown | CEP, CoA, GMP, JDMF, USDMF | 93 products |
When sending a request, specify which Hydroxocobalamin API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
Use the list above to find high-quality Hydroxocobalamin API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
Frequently asked questions about Hydroxocobalamin API
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Technical
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Regulatory
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