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Isosorbide mononitrate | CAS No: 16051-77-7 | GMP-certified suppliers
A medication that helps prevent and manage chronic angina associated with coronary artery disease, supporting consistent symptom control for cardiovascular therapy needs.
Therapeutic categories
AlcoholsAntianginal AgentsCarbohydratesCardiac TherapyCardiovascular AgentsDelayed-Action Preparations
Generic name
Isosorbide mononitrate
Molecule type
small molecule
CAS number
16051-77-7
DrugBank ID
DB01020
Approval status
Approved drug
ATC code
C01DA14
Primary indications
- Isosorbide mononitrate is indicated for the prevention and management of angina pectoris due to coronary artery disease
- The onset of action of oral isosorbide mononitrate is not sufficiently rapid to be useful in aborting an acute anginal episode
Product Snapshot
- Oral small‑molecule nitrate available mainly as immediate- and extended‑release tablets and capsules
- Used for prevention and ongoing management of angina associated with coronary artery disease
- Approved in major regulated markets including the US and Canada
Clinical Overview
Isosorbide mononitrate (CAS 16051-77-7) is an organic nitrate used for the prevention and long‑term management of angina pectoris associated with coronary artery disease. It is not suitable for rapid relief of acute anginal episodes because its onset after oral dosing is delayed. The molecule is an isosorbide derivative and the pharmacologically active species is nitric oxide, formed during metabolic conversion.
The drug’s therapeutic effect is based on nitric‑oxide–mediated vasodilation. Nitric oxide activates soluble guanylyl cyclase, increases intracellular cGMP, and triggers protein kinase–dependent pathways that lower intracellular calcium. This promotes dephosphorylation of myosin light chains and relaxation of vascular smooth muscle. Venodilation predominates, reducing central venous pressure and cardiac preload. At therapeutic concentrations, larger muscular arteries also dilate, lowering systemic vascular resistance and cardiac afterload. Coronary vasodilation helps counteract coronary artery spasm and improves flow to ischemic regions.
Pharmacodynamic effects include reduced myocardial oxygen demand and, at higher exposures, increased coronary blood flow. Onset of anti‑anginal activity typically occurs about one hour after dosing, with peak effects within one to four hours. Duration of action of at least 12 hours has been demonstrated with appropriate extended‑release or asymmetrical regimens.
Isosorbide mononitrate is administered orally and exhibits slow absorption compared with other nitrates. It is primarily metabolized to nitric oxide–releasing species and is considered mainly renally excreted. As with other organic nitrates, tolerance can develop, and dosing schedules that include a daily nitrate‑free interval are commonly required. Common adverse effects reflect vasodilation and may include headache, postural hypotension, dizziness, and reflex tachycardia. Excessive dosing can increase the risk of significant hypotension or, rarely, methemoglobinemia.
Immediate‑release products are available generically and under names such as ISMO and Monoket; extended‑release forms include generic versions and Imdur.
For API procurement, ensure compliance with compendial specifications, control of nitrate impurities, and verification of stability under conditions that limit moisture and oxidative degradation.
The drug’s therapeutic effect is based on nitric‑oxide–mediated vasodilation. Nitric oxide activates soluble guanylyl cyclase, increases intracellular cGMP, and triggers protein kinase–dependent pathways that lower intracellular calcium. This promotes dephosphorylation of myosin light chains and relaxation of vascular smooth muscle. Venodilation predominates, reducing central venous pressure and cardiac preload. At therapeutic concentrations, larger muscular arteries also dilate, lowering systemic vascular resistance and cardiac afterload. Coronary vasodilation helps counteract coronary artery spasm and improves flow to ischemic regions.
Pharmacodynamic effects include reduced myocardial oxygen demand and, at higher exposures, increased coronary blood flow. Onset of anti‑anginal activity typically occurs about one hour after dosing, with peak effects within one to four hours. Duration of action of at least 12 hours has been demonstrated with appropriate extended‑release or asymmetrical regimens.
Isosorbide mononitrate is administered orally and exhibits slow absorption compared with other nitrates. It is primarily metabolized to nitric oxide–releasing species and is considered mainly renally excreted. As with other organic nitrates, tolerance can develop, and dosing schedules that include a daily nitrate‑free interval are commonly required. Common adverse effects reflect vasodilation and may include headache, postural hypotension, dizziness, and reflex tachycardia. Excessive dosing can increase the risk of significant hypotension or, rarely, methemoglobinemia.
Immediate‑release products are available generically and under names such as ISMO and Monoket; extended‑release forms include generic versions and Imdur.
For API procurement, ensure compliance with compendial specifications, control of nitrate impurities, and verification of stability under conditions that limit moisture and oxidative degradation.
Identification & chemistry
| Generic name | Isosorbide mononitrate |
|---|---|
| Molecule type | Small molecule |
| CAS | 16051-77-7 |
| UNII | LX1OH63030 |
| DrugBank ID | DB01020 |
Pharmacology
| Summary | Isosorbide mononitrate acts as a nitric‑oxide–releasing prodrug that activates soluble guanylyl cyclase, elevates cGMP levels, and drives smooth‑muscle relaxation through reduced intracellular calcium. Its pharmacologic effects primarily involve venous and large‑artery dilation, lowering cardiac preload and afterload while improving coronary blood flow. These actions support its use in preventing and managing angina associated with coronary artery disease. |
|---|---|
| Mechanism of action | Isosorbide mononitrate acts as a prodrug for nitric oxide (NO), which is a potent vasodilator gas that is released when the drug is metabolized. NO activates soluble guanylyl cyclase in vascular endothelial cells, which increases the intracellular concentrations of cyclic GMP (cGMP). cGMP activates cGMP-dependent protein kinases, such as protein kinase G and I, which activates the downstream intracellular cascades.The downstream cascade results in reduced intracellular concentrations of calcium, caused by processes including inhibition of IP<sub>3</sub>-mediated pathway, phosphorylation of big calcium-activated potassium channel leading to cell hyperpolarization and reduced calcium influx, and increased calcium efflux via the Ca2+-ATPase-pump.Reduced intracellular calcium concentrations lead to the dephosphorylation of myosin light chains and the relaxation of smooth muscle cells. |
| Pharmacodynamics | Isosorbide mononitrate is an anti-anginal agent and vasodilator that relaxes vascular smooth muscle to prevent and manage angina pectoris. The pharmacological action is mediated by the active metabolite, [nitric oxide], which is released when isosorbide mononitrate is metabolized.Nitric oxide works on both arteries and veins, but predominantly veins: by relaxing veins and reducing the central venous pressure, nitric oxide causes venous pooling and a decrease in the venous return to the heart, thus decreasing cardiac preload.In healthy subjects, the stroke volume is decreased and venous pooling can occur in the standing posture, leading to postural hypotension and dizziness. At therapeutic doses of isosorbide mononitrate, nitric oxide has a bigger effect on larger muscular arteries over small resistance arteries. Arterial relaxation leads to reduced systemic vascular resistance and systolic blood (aortic) pressure, decreasing to decreased cardiac afterload.The direct dilator effect on coronary arteries opposes the coronary artery spasm in variant angina or angina pectoris.At larger doses, nitric oxide causes the resistance arteries and arterioles to dilate, reducing arterial pressure via coronary vasodilatation. This leads to increased coronary blood flow.Reduced cardiac preload and afterload caused by nitric oxide causes a reduction in myocardial oxygen consumption; decreased myocardial oxygen demand, along with increased coronary blood flow, leads to an increased in the oxygen content of coronary sinus blood and the relief from ischemia. The end effect of isosorbide mononitrate include decreased cardiac oxygen consumption, redistribution coronary flow toward ischemic areas via collaterals, and the relief of coronary spasms. Nitric oxide can also increase the rate of relaxation of cardiac muscles, which is an effect outside of vascular smooth muscles.Organic nitrates can also relax other types of smooth muscles, including esophageal and biliary smooth muscle.The anti-anginal activity of isosorbide mononitrate was observed about 1 hour after dosing, and the peak effect was achieved from 1-4 hours after dosing.The duration of anti-anginal action of at least 12 hours was observed with an asymmetrical dosing regimen. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Guanylate cyclase soluble subunit alpha-2 | Humans | activator |
ADME / PK
| Absorption | Upon oral administration, isosorbide mononitrate is rapidly and completely absorbed from the gastrointestinal tract. Isosorbide mononitrate has a dose-linear kinetics and the absolute bioavailability is nearly 100%. The Cmax is reached within 30 to 60 minutes following administration. |
|---|---|
| Half-life | The elimination half-life of isosorbide mononitrate is about 5 hours.The elimination half-life of its metabolites, isosorbide and 2-glucuronide of mononitrate, are 8 hours and 6 hours, respectively. |
| Protein binding | Isosorbide mononitrate is about 5% bound to plasma proteins. |
| Metabolism | Isosorbide mononitrate is not subject to first pass metabolism in human liver.Detectable metabolites include isosorbide, sorbitol, and 2-glucuronide of mononitrate, which are pharmacologically inactive. |
| Route of elimination | In a human radio-labelled drug study, about 93% of the total dose was excreted in the urine within 48 hours.Following oral administration of 20 mg, only 2% of isosorbide mononitrate was excreted unchanged in the urine within 24 hours. Among the excreted dose, nearly half of the dose was found de-nitrated in urine as isosorbide and sorbitol: approximately 30% is excreted as isosorbide and about 17% is the 2-glucuronide of mononitrate.These metabolites were not vasoactive or pharmacologically active. Renal excretion was complete after 5 days, and fecal excretion accounted for only 1% of drug elimination. |
| Volume of distribution | The volume of distribution is approximately 0.6 L/kg, which is approximately the volume of total body water. |
| Clearance | The total body clearance is 115-120 mL/min. |
Formulation & handling
- High aqueous solubility and small‑molecule profile support simple oral solid formulations, including immediate‑ and extended‑release matrices or coated pellets.
- Extended‑release systems require controlled diffusion or erosion mechanisms due to rapid intrinsic solubility and to maintain stable plasma exposure.
- Food has minimal impact on absorption, allowing flexible administration without special excipient strategies for food‑effect mitigation.
Regulatory status
| Lifecycle | Patent expiry timing in Canada and the US positions the API in a mature stage of its lifecycle, with established market presence in both regions. Continued availability across these markets suggests stable generic competition and limited remaining exclusivity drivers. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | Isosorbide mononitrate was originally developed by a small number of originator companies, but the current supply landscape is dominated by numerous generic manufacturers that produce the active ingredient and finished‑dose products. Branded versions such as Imdur have long been established in the US, Canada, and other markets, but loss of exclusivity occurred years ago. Patent expiry has enabled broad global generic competition, reflected by the large number of manufacturers and repackagers active in North America. |
|---|
Safety
| Toxicity | The oral LD<sub>50</sub> is 2010 mg/kg in rats and 1771 mg/kg in mice. The symptoms of overdose from isosorbide mononitrate is associated with vasodilatation, venous pooling, reduced cardiac output, and hypotension. These symptoms can be accompanied by several manifestations, including increased intracranial pressure (possibly along with persistent throbbing headache, confusion, and moderate fever), vertigo, palpitations, visual disturbances, nausea and vomiting (possibly along with colic and bloody diarrhea), syncope (especially in the upright posture), air hunger and dyspnea (later followed by reduced ventilatory effort), diaphoresis (with flushed or cold and clammy skin), heart blocks and bradycardia, paralysis, coma, seizures, and death. There is limited clinical information on the management of isosorbide mononitrate overdose; it is advised that venodilatation and arterial hypovolemia from overdose are responded with therapy aimed to increase in central fluid volume. However, this method may be potentially hazardous in patients with renal disease or congestive heart failure: invasive monitoring may be required in these patients. The patient's legs should be passively elevated, and intravenous infusion of normal saline or similar fluid is recommended. Isosorbide mononitrate was shown to be significantly removed from the systemic circulation via hemodialysis. The use of epinephrine or other arterial vasoconstrictors is not recommended. |
|---|
High Level Warnings:
- Oral LD50 values are 2010 mg/kg in rats and 1771 mg/kg in mice, indicating moderate acute toxicity in animal models
- Overexposure can induce pronounced vasodilation with hypotension, reduced cardiac output, venous pooling, and secondary effects such as elevated intracranial pressure, neurologic disturbances, and cardiopulmonary depression
- Severe toxicity may progress to conduction abnormalities, bradycardia, seizures, or coma
Isosorbide Mononitrate is a type of Anti-anginal agents
Anti-anginal agents are a category of pharmaceutical active pharmaceutical ingredients (APIs) used for the treatment of angina, a condition characterized by chest pain or discomfort caused by reduced blood flow to the heart muscle. These APIs target the underlying cause of angina, which is often related to insufficient blood supply to the heart.
One commonly used anti-anginal agent is nitroglycerin, which belongs to the class of organic nitrates. Nitroglycerin works by dilating blood vessels, including the coronary arteries that supply blood to the heart. This dilation improves blood flow to the heart, relieving chest pain and reducing the workload on the heart.
Another class of anti-anginal agents is calcium channel blockers (CCBs). CCBs inhibit the movement of calcium ions into heart muscle cells and blood vessel walls. By doing so, they relax and widen blood vessels, enhancing blood flow to the heart and reducing the frequency and severity of angina episodes.
Beta blockers are also commonly used in the treatment of angina. These agents block the effects of adrenaline and other stress hormones on the heart, resulting in reduced heart rate and blood pressure. By slowing down the heart's activity, beta blockers decrease the demand for oxygen and reduce angina symptoms.
Anti-anginal agents play a crucial role in managing angina, providing relief to patients and improving their quality of life. It is important to consult with healthcare professionals for proper diagnosis, prescription, and usage of these pharmaceutical APIs to ensure safe and effective treatment of angina.
Isosorbide Mononitrate API manufacturers & distributors
Compare qualified Isosorbide Mononitrate API suppliers worldwide. We currently have 3 companies offering Isosorbide Mononitrate API, with manufacturing taking place in 2 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 |
|---|---|---|---|---|---|
| Curia | Producer | United States | India | CEP, CoA, GMP, MSDS | 106 products |
| Finekem Labs. | Producer | India | India | CEP, CoA | 1 products |
| Rochem International, Inc... | Distributor | United States | United States | BSE/TSE, CEP, CoA, GMP, ISO9001, MSDS, USDMF | 144 products |
When sending a request, specify which Isosorbide Mononitrate 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 Isosorbide Mononitrate 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 Isosorbide Mononitrate API
Sourcing
What matters most when sourcing GMP-grade Isosorbide Mononitrate?
Key considerations include confirming GMP compliance and meeting US and Canadian regulatory requirements, including appropriate filings and quality documentation. Consistent batch quality is essential given the wide generic manufacturing base. Verification of supplier reliability and traceability is important because the market includes many producers and repackagers.
Which documents are typically required when sourcing Isosorbide Mononitrate API?
Request the core API documentation set: CEP (3 companies), CoA (3 companies), GMP (2 companies), MSDS (2 companies), USDMF (1 company). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Isosorbide Mononitrate API?
Known or reported manufacturers for Isosorbide Mononitrate: Rochem International, Inc.. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Isosorbide Mononitrate 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 Isosorbide Mononitrate manufacturers?
Audit reports may be requested for Isosorbide Mononitrate: 2 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Isosorbide Mononitrate API on Pharmaoffer?
Reported supplier count for Isosorbide Mononitrate: 3 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Isosorbide Mononitrate API?
Production countries reported for Isosorbide Mononitrate: India (2 producers), United States (1 producer). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Isosorbide Mononitrate usually hold?
Common certifications for Isosorbide Mononitrate suppliers: CEP (3 companies), CoA (3 companies), GMP (2 companies), MSDS (2 companies), USDMF (1 company). Always verify issuing authorities and expiry dates when reviewing audit packages.
Technical
What is Isosorbide Mononitrate (CAS 16051-77-7) used for?
Isosorbide Mononitrate is used for the prevention and long‑term management of angina pectoris in patients with coronary artery disease. It works by releasing nitric oxide, which produces venous and arterial vasodilation, lowering cardiac preload and afterload and improving coronary blood flow. It is not intended for rapid relief of acute anginal attacks due to its delayed onset after oral dosing.
Which therapeutic class does Isosorbide Mononitrate fall into?
Isosorbide Mononitrate belongs to the following therapeutic categories: Alcohols, Antianginal Agents, Carbohydrates, Cardiac Therapy, Cardiovascular Agents. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Isosorbide Mononitrate mainly prescribed for?
The primary indications for Isosorbide Mononitrate: Isosorbide Mononitrate is indicated for the prevention and management of angina pectoris due to coronary artery disease, The onset of action of oral Isosorbide Mononitrate is not sufficiently rapid to be useful in aborting an acute anginal episode. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Isosorbide Mononitrate work?
Isosorbide Mononitrate acts as a prodrug for nitric oxide (NO), which is a potent vasodilator gas that is released when the drug is metabolized. NO activates soluble guanylyl cyclase in vascular endothelial cells, which increases the intracellular concentrations of cyclic GMP (cGMP). cGMP activates cGMP-dependent protein kinases, such as protein kinase G and I, which activates the downstream intracellular cascades.The downstream cascade results in reduced intracellular concentrations of calcium, caused by processes including inhibition of IP3-mediated pathway, phosphorylation of big calcium-activated potassium channel leading to cell hyperpolarization and reduced calcium influx, and increased calcium efflux via the Ca2+-ATPase-pump.Reduced intracellular calcium concentrations lead to the dephosphorylation of myosin light chains and the relaxation of smooth muscle cells.
What should someone know about the safety or toxicity profile of Isosorbide Mononitrate?
Isosorbide Mononitrate shows moderate acute toxicity in animals, with oral LD50 values of 2010 mg/kg in rats and 1771 mg/kg in mice. Excess exposure can cause marked vasodilation leading to hypotension, reduced cardiac output, venous pooling, and secondary neurologic or cardiopulmonary effects. Severe toxicity may include conduction abnormalities, bradycardia, seizures, or coma. At therapeutic doses, adverse effects typically reflect vasodilation, such as headache, dizziness, postural hypotension, and reflex tachycardia.
What are important formulation and handling considerations for Isosorbide Mononitrate as an API?
Isosorbide Mononitrate’s high aqueous solubility allows straightforward development of immediate‑release oral solids and supports extended‑release matrices or coated pellet systems. Extended‑release designs need mechanisms that regulate diffusion or erosion to counter its rapid dissolution and maintain stable plasma levels. Food has minimal impact on absorption, so no special strategies for food‑effect control are typically required. Handling focuses on maintaining standard API stability and ensuring uniform incorporation into controlled‑release systems.
Is Isosorbide Mononitrate a small molecule?
Isosorbide Mononitrate is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Isosorbide Mononitrate?
Isosorbide Mononitrate has high aqueous solubility and a simple small‑molecule profile, which generally supports stable oral solid formulations. For extended‑release products, the main stability consideration is maintaining the integrity of the diffusion or erosion mechanism needed to control release despite the drug’s rapid intrinsic solubility. No special stability concerns beyond standard solid‑dose handling are indicated in the provided context.
Regulatory
Where is Isosorbide Mononitrate approved or in use globally?
Isosorbide Mononitrate 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 Isosorbide Mononitrate right now?
Isosorbide Mononitrate is an established active ingredient approved for prescription use in both Canada and the United States. As a long‑marketed molecule, it is generally considered off‑patent and not subject to new market exclusivities.
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Isosorbide Mononitrate procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Isosorbide Mononitrate. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Isosorbide Mononitrate included in the PRO Data Insights coverage?
PRO Data Insights coverage for Isosorbide Mononitrate: 332 verified transactions across 88 suppliers and 58 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Isosorbide Mononitrate?
Market report availability for Isosorbide Mononitrate: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.
