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Cyanocobalamin | CAS No: 68-19-9 | GMP-certified suppliers
A medication that supports correction and maintenance of vitamin B12 levels in patients with deficiency arising from malabsorption, pernicious anemia, or other increased physiological needs.
Therapeutic categories
Antianemic PreparationsBlood and Blood Forming OrgansCorrinoidsDiet, Food, and NutritionDrugs that are Mainly Renally ExcretedFood
Generic name
Cyanocobalamin
Molecule type
small molecule
CAS number
68-19-9
DrugBank ID
DB00115
Approval status
Approved drug, Nutraceutical drug
ATC code
B03BA01
Primary indications
- Nasal spray**
- The cyanocobalamin nasal spray is indicated for the maintenance of vitamin B12 concentrations after normalization with intramuscular vitamin B12 therapy in patients with deficiency of this vitamin who have no nervous system involvement [FDA label]
- Note: CaloMist [FDA label], the nasal spray form, has not been evaluated for the treatment of newly diagnosed vitamin B12 deficiency
- Injection forms (subcutaneous, intramuscular)**
Product Snapshot
- Cyanocobalamin is available as injectable, oral, and nasal formulations, including a metered nasal spray for maintenance after parenteral correction
- Its primary use is to support vitamin B12 repletion and maintenance in deficiency states driven by malabsorption or increased physiological demand
- It is approved in the US and Canada, with nasal and injectable forms holding FDA authorization and oral forms widely marketed as approved products or nutraceuticals
Clinical Overview
Cyanocobalamin (CAS 68-19-9) is a synthetic form of vitamin B12 and a representative cobalamin derivative characterized by a corrin ring with a central cobalt atom. It is used clinically to correct and maintain adequate vitamin B12 status across multiple routes of administration. Vitamin B12 deficiency commonly arises from impaired absorption and may manifest with hematologic, gastrointestinal, or neurologic abnormalities.
For nasal administration, cyanocobalamin is indicated for maintaining vitamin B12 concentrations in patients previously stabilized with intramuscular therapy and without nervous system involvement. The intranasal route supports ongoing replacement but has not been evaluated for initial correction of deficiency. Injection forms, given subcutaneously or intramuscularly, are indicated for deficiencies due to pernicious anemia, gastrointestinal pathology or surgery, malabsorption syndromes, parasitic infection, and conditions associated with increased B12 requirements. Oral preparations are suitable for supplementation when gastrointestinal absorption is intact.
Cyanocobalamin restores vitamin B12–dependent metabolic functions. Pharmacodynamic effects include normalization of megaloblastic hematopoiesis, improvement of epithelial integrity, and prevention of progression of neurologic impairment when parenteral therapy is initiated promptly. In patients stabilized on intramuscular therapy, intranasal dosing has been shown to maintain serum concentrations above typical therapeutic thresholds.
The mechanism of action reflects its role as a cofactor for methionine synthase and L‑methylmalonyl‑CoA mutase. These pathways support DNA synthesis, methylation reactions, myelin maintenance, and conversion of methylmalonyl‑CoA to succinyl‑CoA, which contributes to hemoglobin synthesis. Deficiency leads to accumulation of methylmalonyl‑CoA, impaired folate cycling, and development of megaloblastic anemia.
Cyanocobalamin is absorbed in the gastrointestinal tract by intrinsic factor–mediated transport, while parenteral and intranasal routes bypass absorption limitations. It is stored primarily in the liver and is renally excreted. Safety considerations include hypersensitivity reactions and the need for parenteral therapy when neurologic involvement is present. CaloMist has been a marketed nasal formulation.
For API procurement, manufacturers should verify cobalt-related impurity control, stability of the corrin ring structure, and compliance with pharmacopeial specifications relevant to cobalamin derivatives.
For nasal administration, cyanocobalamin is indicated for maintaining vitamin B12 concentrations in patients previously stabilized with intramuscular therapy and without nervous system involvement. The intranasal route supports ongoing replacement but has not been evaluated for initial correction of deficiency. Injection forms, given subcutaneously or intramuscularly, are indicated for deficiencies due to pernicious anemia, gastrointestinal pathology or surgery, malabsorption syndromes, parasitic infection, and conditions associated with increased B12 requirements. Oral preparations are suitable for supplementation when gastrointestinal absorption is intact.
Cyanocobalamin restores vitamin B12–dependent metabolic functions. Pharmacodynamic effects include normalization of megaloblastic hematopoiesis, improvement of epithelial integrity, and prevention of progression of neurologic impairment when parenteral therapy is initiated promptly. In patients stabilized on intramuscular therapy, intranasal dosing has been shown to maintain serum concentrations above typical therapeutic thresholds.
The mechanism of action reflects its role as a cofactor for methionine synthase and L‑methylmalonyl‑CoA mutase. These pathways support DNA synthesis, methylation reactions, myelin maintenance, and conversion of methylmalonyl‑CoA to succinyl‑CoA, which contributes to hemoglobin synthesis. Deficiency leads to accumulation of methylmalonyl‑CoA, impaired folate cycling, and development of megaloblastic anemia.
Cyanocobalamin is absorbed in the gastrointestinal tract by intrinsic factor–mediated transport, while parenteral and intranasal routes bypass absorption limitations. It is stored primarily in the liver and is renally excreted. Safety considerations include hypersensitivity reactions and the need for parenteral therapy when neurologic involvement is present. CaloMist has been a marketed nasal formulation.
For API procurement, manufacturers should verify cobalt-related impurity control, stability of the corrin ring structure, and compliance with pharmacopeial specifications relevant to cobalamin derivatives.
Identification & chemistry
| Generic name | Cyanocobalamin |
|---|---|
| Molecule type | Small molecule |
| CAS | 68-19-9 |
| UNII | P6YC3EG204 |
| DrugBank ID | DB00115 |
Pharmacology
| Summary | Vitamin B12 supports one‑carbon metabolism by serving as a cofactor for methionine synthase and L‑methylmalonyl‑CoA mutase, enabling DNA synthesis, methylation reactions, and propionate catabolism. Through these roles, it maintains normal hematologic function, myelin integrity, and cellular energy pathways. Cyanocobalamin administration restores deficient B12 levels and reverses the metabolic disturbances underlying megaloblastic anemia and neurologic dysfunction. |
|---|---|
| Mechanism of action | Vitamin B12 serves as a cofactor for _methionine synthase_ and _L-methylmalonyl-CoA mutase_ enzymes. Methionine synthase is essential for the synthesis of purines and pyrimidines that form DNA. L-methylmalonyl-CoA mutase converts L-methylmalonyl-CoA to _succinyl-CoA_ in the degradation of propionate , an important reaction required for both fat and protein metabolism. It is a lack of vitamin B12 cofactor in the above reaction and the resulting accumulation of methylmalonyl CoA that is believed to be responsible for the neurological manifestations of B12 deficiency . Succinyl-CoA is also necessary for the synthesis of hemoglobin . In tissues, vitamin B12 is required for the synthesis of _methionine_ from homocysteine. Methionine is required for the formation of S-adenosylmethionine, a methyl donor for nearly 100 substrates, comprised of DNA, RNA, hormones, proteins, as well as lipids . Without vitamin B12, tetrahydrofolate cannot be regenerated from 5-methyltetrahydrofolate, and this can lead to functional folate deficiency , [FDA label]. This reaction is dependent on methylcobalamin (vitamin B12) as a co-factor and is also dependent on folate, in which the methyl group of methyltetrahydrofolate is transferred to homocysteine to form _methionine_ and _tetrahydrofolate_. Vitamin B12 incorporates into circulating folic acid into growing red blood cells; retaining the folate in these cells . A deficiency of vitamin B12 and the interruption of this reaction leads to the development of megaloblastic anemia. |
| Pharmacodynamics | **General effects** Cyanocobalamin corrects vitamin B12 deficiency and improves the symptoms and laboratory abnormalities associated with pernicious anemia (megaloblastic indices, gastrointestinal lesions, and neurologic damage). This drug aids in growth, cell reproduction, hematopoiesis, nucleoprotein, and myelin synthesis. It also plays an important role in fat metabolism, carbohydrate metabolism, as well as protein synthesis. Cells that undergo rapid division (for example, epithelial cells, bone marrow, and myeloid cells) have a high demand for vitamin B12 . **Parenteral cyanocobalamin effects** The parenteral administration of vitamin B12 rapidly and completely reverses the megaloblastic anemia and gastrointestinal symptoms of vitamin B12 deficiency. Rapid parenteral administration of vitamin B12 in deficiency related neurological damage prevents the progression of this condition . **Nasal spray effects** In 24 vitamin B12 deficient patients who were already stabilized on intramuscular (IM) vitamin B12 therapy, single daily doses of intranasal cyanocobalamin for 8 weeks lead to serum vitamin B12 concentrations that were within the target therapeutic range (>200 ng/L) [FDA label]. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Methionine synthase | Humans | cofactor |
| Methylmalonyl-CoA mutase, mitochondrial | Humans | cofactor |
| Methionine synthase reductase | Humans | cofactor |
ADME / PK
| Absorption | Vitamin B12 is quickly absorbed from intramuscular (IM) and subcutaneous (SC) sites of injection; with peak plasma concentrations achieved about 1 hour after IM injection . Orally administered vitamin B12 binds to intrinsic factor (IF) during its transport through the stomach. The separation of Vitamin B12 and IF occurs in the terminal ileum when calcium is present, and vitamin B12 is then absorbed into the gastrointestinal mucosal cells. It is then transported by transcobalamin binding proteins . Passive diffusion through the intestinal wall can occur, however, high doses of vitamin B12 are required in this case (i.e. >1 mg). After the administration of oral doses less than 3 mcg, peak plasma concentrations are not reached for 8 to 12 hours, because the vitamin is temporarily retained in the wall of the lower ileum . |
|---|---|
| Half-life | Approximately 6 days (400 days in the liver) . |
| Protein binding | Very high (to specific plasma proteins called transcobalamins); binding of hydroxocobalamin is slightly higher than cyanocobalamin [FDA label. |
| Metabolism | Vitamin B12 or cyanocobalamin obtained from food is initially bound by _haptocorrin_, a protein found in the saliva with high affinity for B12. This forms a _haptocorrin-B12_ complex. Cyanocobalamin passes through the stomach and is protected from acid degradation due to its binding to haptocorrin. In the duodenum, pancreatic _proteases_ release cobalamin from the _haptocorrin-B12 complex_ and from other proteins containing protein-bound B12 that have been ingested. Following this, the binding of cobalamin to a second glycoprotein, _intrinsic factor_, promotes its uptake by terminal ileum mucosal cells by a process called _cubilin_/AMN receptor-mediated endocytosis. After absorption into enterocytes, intrinsic factor is broken down in the lysosome, and cobalamin is then released into the bloodstream. The transporter ABCC1, found in the basolateral membrane of intestinal epithelial and other cells, exports cobalamin bound to transcobalamin out of the cell . Cyanocobalamin then passes through the portal vein in the liver, and then reaches the systemic circulation. The active forms of cyanocobalamin are _methylcobalamin_ and _adenosylcobalamin_ , . |
| Route of elimination | This drug is partially excreted in the urine . According to a clinical study, approximately 3-8 mcg of vitamin B12 is secreted into the gastrointestinal tract daily via the bile. In patients with adequate levels of intrinsic factor, all except approximately 1 mcg is reabsorbed. When vitamin B12 is administered in higher doses that saturate the binding capacity of plasma proteins and the liver, the unbound vitamin B12 is eliminated rapidly in the urine. The body storage of vitamin B12 is dose-dependent [FDA label]. |
| Volume of distribution | Cobalamin is distributed to tissues and stored mainly in the liver and bone marrow [FDA label]. |
| Clearance | During vitamin loading, the kidney accumulates large amounts of unbound vitamin B12. This drug is cleared partially by the kidney, however, multiligand receptor _megalin_ promotes the reuptake and reabsorption of vitamin B12 into the body , . |
Formulation & handling
- Cyanocobalamin is a water‑soluble cobalamin derivative used across oral, nasal, transdermal, and parenteral formulations, with low LogP and poor aqueous solubility influencing excipient selection for solid and liquid products.
- Parenteral products rely on solution or reconstitutable powder forms, with the corrin‑cobalt structure generally stable but sensitive to strong light and reducing agents, requiring protected handling.
- Oral formulations face limited passive permeability and low solubility, so dissolution‑enhancing excipients or high‑load formulations are commonly required, while food has minimal impact on absorption.
Regulatory status
| Lifecycle | Most US patents for the API expired in 2024, indicating a transition toward a post‑exclusivity phase. With commercialization limited to the US and Canada, the product now sits in a mature market environment where generic entry is likely to increase. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | The manufacturing landscape for cyanocobalamin is highly fragmented, with numerous long‑established pharmaceutical producers supplying the active ingredient and finished formulations rather than a single dominant originator. Branded and unbranded products are widely available in North American markets, with distribution across both the United States and Canada. Listed U.S. patents expiring in 2024 suggest that any remaining protection relates to specific formulations or delivery technologies, and the core ingredient already faces broad generic competition. |
|---|
Safety
| Toxicity | LD50 Oral (mouse): > 5,000 mg/kg . **General toxicity** Vitamin B12 is generally non-toxic, even at higher doses. Mild, transient diarrhea, polycythemia vera, peripheral vascular thrombosis, itching, transitory exanthema, a feeling of swelling of entire body, pulmonary edema and congestive heart failure in early treatment stages, anaphylactic shock and death have been observed after vitamin B12 administration . **Carcinogenesis and mutagenesis** Long term studies in animals examining the carcinogenic potential of any of the vitamin B12 formulations have not completed to date. There is no evidence from long-term use in patients with pernicious anemia that vitamin B12 has carcinogenic potential. Pernicious anemia is known to be associated with an increased incidence of stomach carcinoma, however, this malignancy has been attributed to the underlying cause of pernicious anemia and has not been found to be related to treatment with vitamin B12 [FDA label]. **Use in pregnancy** No adverse effects have been reported with ingestion of normal daily requirements during pregnancy . **A note on the use of the nasal spray in pregnancy** Although vitamin B12 is an essential vitamin and requirements are increased during pregnancy, it is currently unknown whether the nasal spray form can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. The nasal spray form should be given to a pregnant woman only if clearly needed, as it is considered a pregnancy category C drug in this form. Sufficient well-controlled studies have not been done to this date in pregnant women [FDA label]. **Use in lactation** Vitamin B12 has been found distributed into the milk of nursing women in concentrations similar to the maternal blood vitamin B12 concentrations. No adverse effects have been reported to date with intake of normal required doses during lactation . |
|---|
High Level Warnings:
- Very low acute toxicity (oral LD50 in mice ›5000 mg/kg), but rare severe reactions reported, including anaphylaxis, pulmonary edema, and transient dermatologic or vascular effects
- No demonstrated carcinogenic or mutagenic signal in available human or animal data, though long‑term animal studies remain incomplete
- Formulation-specific risks noted for the nasal spray, including limited reproductive‑toxicity data and pregnancy category C classification
Cyanocobalamin 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.
Cyanocobalamin (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.
Cyanocobalamin API manufacturers & distributors
Compare qualified Cyanocobalamin API suppliers worldwide. We currently have 14 companies offering Cyanocobalamin API, with manufacturing taking place in 4 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 |
|---|---|---|---|---|---|
| Air Products | Producer | France | Poland | CoA, GMP | 4 products |
| Arshine Pharmaceutical Co... | Distributor | China | China | BSE/TSE, CEP, CoA, FDA, GMP, MSDS, USDMF | 176 products |
| Aurora Industry Co., Ltd | Distributor | China | China | BSE/TSE, CEP, CoA, GMP, ISO9001, MSDS, WC | 250 products |
| Caesar & Loretz GmbH (CAE... | Distributor | Germany | China | BSE/TSE, CoA, GMP, ISO9001, MSDS | 211 products |
| Changzhou Comwin Fine Che... | Producer | China | China | BSE/TSE, CoA, GMP, ISO9001, MSDS, USDMF, WC | 235 products |
| Chr. Olesen Group | Distributor | Denmark | China | CEP, CoA, GMP, MSDS, USDMF | 252 products |
| Hebei Huarong | Producer | China | China | CEP, CoA, GMP | 4 products |
| Hebei Jiheng | Producer | China | China | CoA, JDMF | 4 products |
| Hebei Yuxing B-E. | Producer | China | China | CEP, CoA | 1 products |
| Meiji Seika | Producer | Japan | Japan | CoA, JDMF | 5 products |
| Ningxia Kingvit | Producer | China | China | CEP, CoA, GMP, WC | 2 products |
| Pharm Rx Chemical Corp | Distributor | United States | Unknown | BSE/TSE, CoA, GMP, MSDS, USDMF | 166 products |
| Sanofi | Producer | France | Unknown | CEP, CoA, FDA, GMP, JDMF, USDMF | 93 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CoA, GMP, ISO9001, MSDS | 762 products |
When sending a request, specify which Cyanocobalamin 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 Cyanocobalamin 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 Cyanocobalamin API
Sourcing
What matters most when sourcing GMP-grade Cyanocobalamin?
Key factors include verifying compliance with U.S. and Canadian regulatory requirements and confirming that the manufacturer operates under GMP standards. Because supply is fragmented and the ingredient already has broad generic competition, evaluating supplier reliability and documentation consistency is essential. It is also important to ensure that any relevant formulation‑ or delivery‑specific patent considerations are addressed when procuring materials.
Which documents are typically required when sourcing Cyanocobalamin API?
Request the core API documentation set: CoA (15 companies), GMP (12 companies), MSDS (8 companies), CEP (7 companies), USDMF (5 companies). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Cyanocobalamin API?
Known or reported manufacturers for Cyanocobalamin: Caesar & Loretz GmbH (CAELO), Xi'an Tian Guangyuan Biotech Co.,Ltd, Changzhou Comwin Fine Chemicals Co., Ltd, Chr. Olesen Group, Aurora Industry Co., Ltd, Pharm Rx Chemical Corp, Sinoway industrial Co.,Ltd, Arshine Pharmaceutical Co., Limited. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Cyanocobalamin API from GMP suppliers?
Submit quote requests through the supplier listings with your specs and required documents (specifications, target volume, delivery timeline, and destination). Providing consistent details upfront speeds comparable offers and clarifies technical feasibility.
Is a GMP audit report available for Cyanocobalamin manufacturers?
Audit reports may be requested for Cyanocobalamin: 6 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Cyanocobalamin API on Pharmaoffer?
Reported supplier count for Cyanocobalamin: 15 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Cyanocobalamin API?
Production countries reported for Cyanocobalamin: China (11 producers), Japan (1 producer), Poland (1 producer). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Cyanocobalamin usually hold?
Common certifications for Cyanocobalamin suppliers: CoA (15 companies), GMP (12 companies), MSDS (8 companies), CEP (7 companies), USDMF (5 companies). Always verify issuing authorities and expiry dates when reviewing audit packages.
Technical
What is Cyanocobalamin (CAS 68-19-9) used for?
Cyanocobalamin is used to correct and maintain vitamin B12 status in deficiency states. It supports hematologic, gastrointestinal, and neurologic function by restoring B12‑dependent metabolic pathways. Clinical use includes treatment of deficiency due to pernicious anemia, malabsorption, gastrointestinal pathology, increased B12 requirements, and maintenance therapy in stabilized patients using intranasal formulations.
Which therapeutic class does Cyanocobalamin fall into?
Cyanocobalamin belongs to the following therapeutic categories: Antianemic Preparations, Blood and Blood Forming Organs, Corrinoids, Diet, Food, and Nutrition, Drugs that are Mainly Renally Excreted. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Cyanocobalamin mainly prescribed for?
The primary indications for Cyanocobalamin: Nasal spray**, The Cyanocobalamin nasal spray is indicated for the maintenance of vitamin B12 concentrations after normalization with intramuscular vitamin B12 therapy in patients with deficiency of this vitamin who have no nervous system involvement [FDA label], Note: CaloMist [FDA label], the nasal spray form, has not been evaluated for the treatment of newly diagnosed vitamin B12 deficiency, Injection forms (subcutaneous, intramuscular)**. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Cyanocobalamin work?
Vitamin B12 serves as a cofactor for _methionine synthase_ and _L-methylmalonyl-CoA mutase_ enzymes. Methionine synthase is essential for the synthesis of purines and pyrimidines that form DNA. L-methylmalonyl-CoA mutase converts L-methylmalonyl-CoA to _succinyl-CoA_ in the degradation of propionate , an important reaction required for both fat and protein metabolism. It is a lack of vitamin B12 cofactor in the above reaction and the resulting accumulation of methylmalonyl CoA that is believed to be responsible for the neurological manifestations of B12 deficiency . Succinyl-CoA is also necessary for the synthesis of hemoglobin .
In tissues, vitamin B12 is required for the synthesis of _methionine_ from homocysteine. Methionine is required for the formation of S-adenosylmethionine, a methyl donor for nearly 100 substrates, comprised of DNA, RNA, hormones, proteins, as well as lipids . Without vitamin B12, tetrahydrofolate cannot be regenerated from 5-methyltetrahydrofolate, and this can lead to functional folate deficiency , [FDA label].
This reaction is dependent on methylcobalamin (vitamin B12) as a co-factor and is also dependent on folate, in which the methyl group of methyltetrahydrofolate is transferred to homocysteine to form _methionine_ and _tetrahydrofolate_. Vitamin B12 incorporates into circulating folic acid into growing red blood cells; retaining the folate in these cells . A deficiency of vitamin B12 and the interruption of this reaction leads to the development of megaloblastic anemia.
What should someone know about the safety or toxicity profile of Cyanocobalamin?
Cyanocobalamin has very low acute toxicity, with rare reports of serious hypersensitivity reactions such as anaphylaxis and pulmonary edema. Transient skin or vascular effects have been observed, and parenteral products should be used cautiously in individuals with a history of allergic reactions. No carcinogenic or mutagenic signal has been identified, although long‑term animal studies are incomplete. The nasal spray carries formulation‑specific considerations, including limited reproductive‑toxicity data and a pregnancy category C designation.
What are important formulation and handling considerations for Cyanocobalamin as an API?
Cyanocobalamin is light‑sensitive and should be protected from strong light and reducing agents during handling and manufacturing. It is water‑soluble but has poor aqueous solubility in practice, so oral formulations often require dissolution‑enhancing excipients or higher drug loads. Parenteral products are typically prepared as solutions or reconstitutable powders, with attention to maintaining stability of the corrin–cobalt structure. Limited passive permeability also influences excipient selection for oral forms.
Is Cyanocobalamin a small molecule?
Cyanocobalamin is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Cyanocobalamin?
Oral Cyanocobalamin is generally stable, but it is sensitive to strong light and reducing agents, so protection from light and incompatible excipients is required. Its low aqueous solubility can affect dissolution, making the choice of dissolution‑enhancing excipients important for maintaining consistent release. No additional food‑related stability concerns are noted.
Regulatory
Where is Cyanocobalamin approved or in use globally?
Cyanocobalamin is reported as approved in the following major regions: Canada, US. Understanding geographic coverage informs regulatory filings, supply planning, and risk assessments before escalating procurement.
What’s the regulatory and patent landscape for Cyanocobalamin right now?
Cyanocobalamin is an established API regulated for use in Canada and the United States under each country’s standard frameworks for vitamin B12 products. In both markets, it follows routine quality, safety, and manufacturing requirements applicable to longstanding APIs.
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Cyanocobalamin procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Cyanocobalamin. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Cyanocobalamin included in the PRO Data Insights coverage?
PRO Data Insights coverage for Cyanocobalamin: 4515 verified transactions across 1145 suppliers and 809 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Cyanocobalamin?
Market report availability for Cyanocobalamin: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.
