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Methylene blue | CAS No: 61-73-4 | GMP-certified suppliers
A medication that treats acquired methemoglobinemia and supports management of vasoplegic states, ifosfamide‑induced neurotoxicity, and selected urinary or hepatic complications across key regulated markets.
Therapeutic categories
Primary indications
- Indicated for the treatment of pediatric and adult patients with acquired methemoglobinemia
- Other clinical applications of methylene blue include improvement of hypotension associated with various clinical states, an antiseptic in urinary tract infections, treatment of hypoxia and hyperdynamic circulation in cirrhosis of liver and severe hepatopulmonary syndrome, and treatment of ifofosamide induced neurotoxicity
Product Snapshot
- Methylene blue is a small‑molecule dye available in oral solid forms and parenteral or topical solutions
- Its primary use is correction of acquired methemoglobinemia, with additional applications in hypotension states, hepatopulmonary dysfunction, urinary antisepsis, and ifosfamide‑related neurotoxicity
- It is approved in the US, Canada, and the EU, with some secondary uses remaining investigational
Clinical Overview
Its primary pharmacological action involves inhibition of nitric oxide synthase and guanylate cyclase, contributing to vasoconstrictive effects. In methemoglobinemia, methylene blue is reduced within erythrocytes to leukomethylene blue, which converts ferric hemoglobin back to the functional ferrous state. For ifosfamide‑induced neurotoxicity, it acts as an alternative electron acceptor, counters NADH accumulation, and inhibits amine oxidase–mediated formation of neurotoxic chloroacetaldehyde. As an antimalarial, it inhibits Plasmodium falciparum glutathione reductase and interferes with heme polymerization.
Methylthioninium chloride has also been investigated for neurodegenerative disorders. Preclinical and early clinical studies suggest effects on tau protein aggregation through oxidation of cysteine sulfhydryl groups, with additional reported antioxidant or anti‑inflammatory activity in animal models. Rember has been one proposed trade name associated with investigational development programs.
Absorption, distribution, metabolism, and excretion characteristics vary by formulation and route, with renal elimination being a notable pathway. Methylene blue interacts with multiple cytochrome P450 isoforms and transporters and is both a substrate and inhibitor of several enzymes, which has relevance for drug–drug interaction risk. Serotonergic activity contributes to a known risk of serotonin syndrome when combined with serotonergic agents. Other safety considerations include dose‑related hypertension, reduced seizure threshold, photosensitivity, and potential neurotoxicity at high exposures.
For API procurement, manufacturers typically emphasize control of polymorphic form, dye‑related impurities, and oxidation state. Quality‑assured sourcing requires verification of identity, purity, and alignment with pharmacopeial or regulatory specifications appropriate to the intended formulation and market.
Identification & chemistry
| Generic name | Methylene blue |
|---|---|
| Molecule type | Small molecule |
| CAS | 61-73-4 |
| UNII | 8NAP7826UB |
| DrugBank ID | DB09241 |
Pharmacology
| Summary | Methylene blue modulates redox and enzymatic pathways by inhibiting nitric oxide synthase and guanylate cyclase and by serving as an alternative electron carrier in tissues under oxidative or metabolic stress. In methemoglobinemia, it is reduced intracellularly to leukomethylene blue, which converts ferric hemoglobin to its functional ferrous form. Additional pharmacologic actions include redox‑based effects on tau cysteine residues, inhibition of P. falciparum glutathione reductase, and blockade of amine‑oxidase–mediated metabolites relevant to ifosfamide‑related neurotoxicity. |
|---|---|
| Mechanism of action | * Main mechanism of action involves inhibition of nitric oxide synthase and guanylate cyclase. * In Alzheimers Disease: a mechanistic study found that methylene blue oxidizes cysteine sulfhydryl groups on tau to keep tau monomeric. One preclinical treatment study in tauopathy mice reported anti-inflammatory or neuroprotective effects mediated by the Nrf2/antioxidant response element (ARE); another reported insoluble tau reduction and a learning and memory benefit when given early. * In Methemoglobinemia: Methylene Blue acts by reacting within RBC to form leukomethylene blue, which is a reducing agent of oxidized hemoglobin converting the ferric ion (fe+++) back to its oxygen-carrying ferrous state(fe++). * As antimalarial agent: Methylene Blue, a specific inhibitor of P.falciparum glutathione reductase has the potential to reverse CQ resistance and it prevents the polymerization of haem into haemozoin similar to 4-amino-quinoline antimalarials. * For ifosfamide induced neurotoxicity: Methylene blue functions as an alternate electron acceptor. It acts to reverse the NADH inhibition caused by gluconeogenesis in the liver while blocking the transformation of chloroethylamine into chloroacetaldehyde. In addition, it inhibits various amine oxidase activities, which also prevents the formation of chloroacetaldehyde. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Guanylate cyclase soluble subunit alpha-2 | Humans | inhibitor |
| Nitric oxide synthase, brain | Humans | inhibitor |
ADME / PK
| Half-life | 5–6.5 hours (after IV dose). |
|---|---|
| Protein binding | Methylene blue was reported to bind strongly to rabbit plasma (71–77% of bound drug). |
| Metabolism | Following distribution into tissues, rapidly reduced to leukomethylene blue (leucomethylthioninium chloride). Metabolism to leucomethylene blue may be less efficient in neonates than in older individuals. |
| Route of elimination | Excreted in urine and bile. About 75% of an oral dose excreted in urine, primarily as stabilized colorless leukomethylene blue. |
| Volume of distribution | 10 mg/kg (in rats). |
| Clearance | 3.0 ± 0.7 L/min. |
Formulation & handling
- Low aqueous solubility requires use of aqueous cosolvents or pH adjustment for parenteral solutions, with attention to potential precipitation on dilution.
- Suitable for oral, topical, ophthalmic, and parenteral formulations; the small‑molecule dye character can lead to strong coloration and staining of equipment and packaging.
- Light sensitivity and oxidative degradation should be considered during handling and storage, with protection from light for solution forms.
Regulatory status
| Lifecycle | Patent expiry across the US, Canada, and the EU suggests the molecule is in a mature phase of its lifecycle, with market dynamics primarily influenced by generic entry and established utilization. Presence in all three regions indicates broad regulatory adoption and a stable, post‑exclusivity market environment. |
|---|
| Markets | US, Canada, EU |
|---|
Supply Chain
| Supply chain summary | Originator production of methylene blue is limited, with a small number of established manufacturers supplying formulations used across the US, Canada, and the EU. Branded products show a long-standing global presence, particularly in Europe, where multiple legacy brands remain available. Patent protection has long expired for this compound, and generic competition is already well‑established. |
|---|
Safety
| Toxicity | LD50 = 1180 mg/kg ( Rat ). |
|---|
- Acute oral toxicity is moderate, with an LD50 of about 1180 mg/kg in rats, indicating the need for controlled handling to limit significant exposure
- Compound may induce oxidative stress–related effects (e
- G
Methylene blue is a type of Disinfectants
Disinfectants are a crucial subcategory of pharmaceutical Active Pharmaceutical Ingredients (APIs) that play a vital role in maintaining cleanliness and preventing the spread of harmful microorganisms. These chemical agents are designed to eliminate or inhibit the growth of bacteria, viruses, fungi, and other pathogens on various surfaces and objects.
Pharmaceutical-grade disinfectants are formulated to meet stringent quality standards and are commonly used in hospitals, laboratories, pharmaceutical manufacturing facilities, and other healthcare settings. They are also utilized in the food and beverage industry, as well as in households, to ensure proper sanitation and hygiene.
Disinfectants typically contain active ingredients such as quaternary ammonium compounds, chlorine compounds, hydrogen peroxide, or alcohol, which have been proven effective against a broad spectrum of microorganisms. These active ingredients work by disrupting the cell membranes or enzymatic processes of the pathogens, rendering them incapable of replication and causing their eventual destruction.
When selecting a disinfectant, factors such as the intended application, target microorganisms, and compatibility with the surfaces or objects being treated need to be considered. It is crucial to follow proper usage instructions and adhere to recommended contact times for effective disinfection.
In conclusion, disinfectants are essential pharmaceutical APIs used to control and prevent the spread of harmful microorganisms. Their efficacy in eliminating pathogens makes them indispensable in maintaining cleanliness and ensuring public health and safety.
Methylene blue (Disinfectants), classified under Antidotes, Deterrents, and Toxicologic Agents
Antidotes, Deterrents, and Toxicologic Agents are an important category of pharmaceutical Active Pharmaceutical Ingredients (APIs) that play a critical role in healthcare and toxicology. These substances are designed to counteract the effects of poisons, toxins, and overdoses, thereby saving lives and preventing severe health consequences.
Antidotes are substances that neutralize the toxic effects of certain drugs, chemicals, or poisons. They work by either directly binding to the toxic substance or by blocking its harmful actions on the body. Antidotes are administered in emergency situations to quickly reverse the effects of poisoning and restore normal physiological functions.
Deterrents, on the other hand, are pharmaceutical agents used to discourage or prevent harmful behaviors, such as substance abuse. They are designed to make the ingestion or misuse of certain substances unpleasant or less desirable. Deterrents can be formulated to cause unpleasant side effects, such as nausea or vomiting, when a particular substance is consumed in excessive amounts.
Toxicologic agents encompass a broad range of pharmaceutical APIs used in toxicology studies and research. These substances are employed to investigate the toxicity, metabolism, and mechanisms of action of various chemicals and compounds. Toxicologic agents are vital for understanding the potential hazards and risks associated with certain substances, ensuring the safety of drugs, and developing effective treatments for poisoning cases.
In conclusion, Antidotes, Deterrents, and Toxicologic Agents are essential categories of pharmaceutical APIs that address poisoning emergencies, deter harmful behaviors, and enable toxicological research. Their development and availability are crucial for safeguarding public health, enhancing patient care, and advancing our understanding of toxicology.
Methylene blue API manufacturers & distributors
Compare qualified Methylene blue API suppliers worldwide. We currently have 6 companies offering Methylene blue 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 |
|---|---|---|---|---|---|
| ChemCon GmbH | Producer | Germany | Germany | CoA, GMP, MSDS, USDMF | 36 products |
| Duchefa Farma B.V. | Distributor | Netherlands | India | CoA, GMP, ISO9001, MSDS | 170 products |
| Hänseler AG | Distributor | Switzerland | Switzerland | CoA, FDA, GDP, GMP | 174 products |
| Macsen Drugs | Producer | India | India | CoA, GMP, ISO9001, WC, WHO-GMP | 2 products |
| PharmaZell | Producer | Germany | India | BSE/TSE, CEP, CoA, EDMF/ASMF, FDA, GDP, GMP, MSDS, USDMF, WC, WHO-GMP | 31 products |
| Sichuan Qingmu Pharmaceut... | Producer | China | China | CoA | 31 products |
When sending a request, specify which Methylene blue 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 Methylene blue 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 Methylene blue API
Sourcing
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Technical
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Regulatory
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