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Nitroglycerin | CAS No: 55-63-0 | GMP-certified suppliers
A medication that supports acute and preventive angina management, aids selected cardiovascular and peri‑operative hypertension needs, and provides localized pain relief in chronic anal fissure.
Therapeutic categories
Agents for Treatment of Hemorrhoids and Anal Fissures for Topical UseAntianginal AgentsAntihypertensive AgentsCardiac TherapyCardiovascular AgentsCompounds used in a research, industrial, or household setting
Generic name
Nitroglycerin
Molecule type
small molecule
CAS number
55-63-0
DrugBank ID
DB00727
Approval status
Approved drug, Investigational drug
ATC code
C01DA02
Primary indications
- Sublingual nitroglycerin is indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease
- Transdermal nitroglycerin is indicated for the prevention of angina pectoris due to coronary artery disease
- Intravenous nitroglycerin is indicated for the treatment of peri-operative hypertension
Product Snapshot
- Nitroglycerin is available as a small‑molecule formulation in sublingual, transdermal, topical, oral, injectable, and inhalation presentations
- Its primary uses are acute and prophylactic management of angina, peri‑operative blood pressure control, adjunct management in acute myocardial infarction–related heart failure, and treatment of pain from chronic anal fissure
- It is approved in the US and Canada, with certain presentations also classified as investigational
Clinical Overview
Nitroglycerin (CAS 55-63-0) is an organic nitrate used globally as a vasodilating agent for acute and chronic management of angina pectoris and for specific cardiovascular indications requiring controlled hemodynamic reduction. It is also applied topically for chronic anal fissure. The compound belongs to the alkyl nitrate class, characterized by a nitrate group O‑linked to an alkyl moiety.
Clinically, sublingual formulations provide rapid relief of acute anginal episodes or short-term prophylaxis. Transdermal systems support longer-term angina prevention. Intravenous administration is used for peri-operative hypertension, acute heart failure associated with myocardial infarction, refractory angina, and induction of intraoperative hypotension. Topical ointment formulations provide localized relaxation of the internal anal sphincter to reduce fissure-related pain.
Pharmacodynamically, nitroglycerin relaxes vascular smooth muscle, producing venous and arteriolar dilation, reducing preload and afterload, lowering myocardial wall stress, and improving coronary perfusion. It also decreases systemic vascular resistance and blood pressure while mitigating coronary artery spasm. With continuous exposure, tolerance may develop, linked to impaired bioactivation via mitochondrial aldehyde dehydrogenase and associated oxidative stress.
Nitroglycerin’s mechanism involves enzymatic conversion to nitric oxide in smooth muscle cells. Nitric oxide activates guanylate cyclase, increasing intracellular cGMP, which initiates kinase-mediated processes that reduce smooth muscle tone across venous, arterial, and coronary vessels. Experimental data show nitric oxide can also interact with natriuretic peptide receptors.
Nitroglycerin is rapidly absorbed through mucosal and cutaneous routes, undergoes hepatic metabolism, and exhibits a short plasma half-life, contributing to the need for formulation-specific dosing strategies. Excess exposure may lead to hypotension, reflex tachycardia, headaches, and methemoglobinemia. Tolerance requires dosing intervals that allow nitrate-free periods.
Commonly recognized brands vary regionally across sublingual, transdermal, injectable, and topical dosage forms.
For API procurement, suppliers should provide validated control of explosive risk, nitrate purity, residual solvent limits, and stability data aligned with pharmacopoeial requirements and global regulatory standards.
Clinically, sublingual formulations provide rapid relief of acute anginal episodes or short-term prophylaxis. Transdermal systems support longer-term angina prevention. Intravenous administration is used for peri-operative hypertension, acute heart failure associated with myocardial infarction, refractory angina, and induction of intraoperative hypotension. Topical ointment formulations provide localized relaxation of the internal anal sphincter to reduce fissure-related pain.
Pharmacodynamically, nitroglycerin relaxes vascular smooth muscle, producing venous and arteriolar dilation, reducing preload and afterload, lowering myocardial wall stress, and improving coronary perfusion. It also decreases systemic vascular resistance and blood pressure while mitigating coronary artery spasm. With continuous exposure, tolerance may develop, linked to impaired bioactivation via mitochondrial aldehyde dehydrogenase and associated oxidative stress.
Nitroglycerin’s mechanism involves enzymatic conversion to nitric oxide in smooth muscle cells. Nitric oxide activates guanylate cyclase, increasing intracellular cGMP, which initiates kinase-mediated processes that reduce smooth muscle tone across venous, arterial, and coronary vessels. Experimental data show nitric oxide can also interact with natriuretic peptide receptors.
Nitroglycerin is rapidly absorbed through mucosal and cutaneous routes, undergoes hepatic metabolism, and exhibits a short plasma half-life, contributing to the need for formulation-specific dosing strategies. Excess exposure may lead to hypotension, reflex tachycardia, headaches, and methemoglobinemia. Tolerance requires dosing intervals that allow nitrate-free periods.
Commonly recognized brands vary regionally across sublingual, transdermal, injectable, and topical dosage forms.
For API procurement, suppliers should provide validated control of explosive risk, nitrate purity, residual solvent limits, and stability data aligned with pharmacopoeial requirements and global regulatory standards.
Identification & chemistry
| Generic name | Nitroglycerin |
|---|---|
| Molecule type | Small molecule |
| CAS | 55-63-0 |
| UNII | G59M7S0WS3 |
| DrugBank ID | DB00727 |
Pharmacology
| Summary | Nitroglycerin is enzymatically converted to nitric oxide, which activates guanylate cyclase and increases cGMP levels in vascular smooth muscle. This signaling promotes venous and arterial dilation, reducing cardiac preload and afterload and improving coronary blood flow. Repeated exposure can produce tolerance linked to reduced bioactivation and associated oxidative effects. |
|---|---|
| Mechanism of action | Nitroglycerin is converted by mitochondrial aldehyde dehydrogenase in smooth muscle cells to nitric oxide (NO), a potent vasodilator. NO activates the enzyme guanylate cyclase, which converts guanosine triphosphate (GTP) to cyclic guanosine 3',5'-monophosphate (cGMP) in vascular smooth muscle and other tissues.cGMP is an endogenous vasodilator of vascular smooth muscle:it causes protein kinase-dependent phosphorylation and activates downstream cascades that promote relaxation and increased blood flow in veins, arteries and cardiac tissue.An _in vitro_ study using mouse aorta suggests that nitric oxide, an active metabolite of nitroglycerin, targets the natriuretic peptide receptors. |
| Pharmacodynamics | Nitroglycerin causes the relaxation of vascular smooth muscles, causing arteriolar and venous dilatation.It increases blood flow to the myocardium and reduces cardiac preload and afterload, decreasing myocardial wall stress and ameliorating anginal symptoms.Nitroglycerin also reduces coronary artery spasm, decreasing systemic vascular resistance as well as systolic and diastolic blood pressure. Like other organic nitrates, repeated and prolonged administration of nitroglycerin can lead to the development of tolerance or desensitization of vascular smooth muscle to further nitroglycerin-induced vasorelaxation. This loss of efficacy may be associated with the inhibition of mitochondrial aldehyde dehydrogenase, which is an important enzyme involved in the bioactivation of nitroglycerin.Nitroglycerin tolerance may be accompanied by pro-oxidant effects, endothelial dysfunction, and increased sensitivity to vasoconstrictors. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Atrial natriuretic peptide receptor 1 | Humans | agonist |
ADME / PK
| Absorption | Nitroglycerin is rapidly absorbed and is often used in emergency situations for this reason.After a sublingual dose of 0.5 mg of nitroglycerin in patients with ischemic heart disease, the peak concentration (C<sub>max</sub>) was 2.56 ng/mL and the mean T<sub>max</sub> was 4.4 minutes. The C<sub>max</sub> following a 0.6mg dose of sublingual nitroglycerin was 2.1 ng/mL and the T<sub>max</sub> was 7.2 minutes.The absolute bioavailability following sublingual administration was about 40%. The bioavailability of nitroglycerin depends on several factors, such as mucosal metabolism and hydration status, which both affect the absorption of sublingual drugs. |
|---|---|
| Half-life | Following intravenous administration, the plasma half-life is about three minutes.The estimated plasma half-life following sublingual administration is approximately six minutes.The elimination half-lives of metabolites 1,2-dinitroglycerin and 1,3-dinitroglycerin range between 32 to 26 minutes. |
| Protein binding | After a sublingual dose of nitroglycerin, at concentrations in the plasma ranging from 50 to 500 ng/mL, plasma protein binding of nitroglycerin is about 60%. The plasma protein binding of the metabolites 1,2-dinitroglycerin is 60% and that of 1,3-dinitroglycerin is 30%. |
| Metabolism | Mitochondrial aldehyde dehydrogenase 2 (ALDH2) promotes the bioactivation of nitroglycerin. Nitroglycerin is metabolized to nitrite; 1,2-glyceryl dinitrate; and 1,3 glyceryl dinitrate.Nitrite is further metabolized to nitric oxide. 1,2- and 1,3-dinitroglycerols are less biologically active than nitroglycerin but they have longer half-lives, which explains some prolonged effects of nitrates. Both dinitrates are finally metabolized to glycerol, carbon dioxide, and mononitrates that do not have vasodilatory actions. Nitroglycerin can also chemically react with a thiol to generate an intermediate S-nitrosothiol, which resulted in further production of nitric oxide. |
| Route of elimination | Metabolism is the main route by which nitroglycerin is eliminated from the body. |
| Volume of distribution | The volume of distribution of nitroglycerin is 3 L/kg. |
| Clearance | The estimated clearance following intravenous administration is 1 L/kg/min.The apparent clearance after a sublingual dose was 21.9 L/min in a pharmacokinetic study of patients with ischemic heart disease and angina. |
Formulation & handling
- Nitroglycerin is a small, volatile liquid molecule with low aqueous solubility, supporting formulation as transdermal patches, IV solutions, sublingual tablets, and sprays for rapid mucosal absorption.
- The API is chemically sensitive to heat, light, and adsorption to plastics, requiring controlled handling and selection of compatible container–closure materials in parenteral and transdermal systems.
- Sublingual and oral formulations bypass significant first‑pass metabolism, while mucosal and transdermal delivery provide rapid or sustained systemic exposure without food‑related constraints aside from alcohol‑induced hypotension risk.
Regulatory status
| Lifecycle | Key U.S. patents for the API have already expired, with additional protections lasting until 2028 and 2032, indicating a mix of mature and still‑protected elements of the portfolio. With commercialization limited to the United States and Canada, the product is progressing toward a later lifecycle stage while retaining some remaining patent exclusivity. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | Nitroglycerin shows a mature manufacturing landscape with many originator and historical developers, reflected in a broad list of API producers and extensive repackaging activity. Branded products appear mainly in the US and Canada, with long‑standing global availability of nitroglycerin formulations. Core molecule patents have long expired, and remaining late‑expiring patents relate to specific formulations or delivery systems, supporting the presence of established generic competition. |
|---|
Safety
| Toxicity | The oral LD50 of nitroglycerin in rats is 105 mg/kg and the LD50 of the intravenous form in rats is 23.2 mg/kg. Nitrate overdosage can result in following conditions: severe hypotension, persistent throbbing headache, vertigo, palpitation, visual disturbance, flushing and perspiring skin (later becoming cold and cyanotic), nausea and vomiting (possibly with colic and even bloody diarrhea), syncope (especially in the upright posture), methemoglobinemia with cyanosis and anorexia, initial hyperpnea, dyspnea and slow breathing, slow pulse (dicrotic and intermittent), heart block, increased intracranial pressure with cerebral symptoms of confusion and moderate fever, paralysis and coma followed by clonic convulsions, and possibly death due to circulatory collapse. Methemoglobinemia can rarely occur at conventional doses of organic nitrates. This condition is dose-related and it can be even more pronounced in patients with genetic abnormalities of hemoglobin that favor methemoglobin formation. Methemoglobinemia can be managed with the administration of methylene blue unless the patient has a known G-6-PD deficiency. There are no known antidotes to an overdose of nitroglycerin, and it is not known whether its metabolites can be removed from the circulation.Hypotension associated with nitroglycerin overdose can be managed with different symptomatic and supportive measures, including the elevation of the lower limbs, administration of intravenous saline or other fluids to maintain central fluid volume, and administration of oxygen and artificial ventilation. Gastric lavage may be used in case of ingestion of excess nitroglycerin. |
|---|
High Level Warnings:
- Rat LD50 values indicate high acute toxicity (oral ≈105 mg/kg
- IV ≈23 mg/kg), underscoring the need for controlled handling and exposure minimization
- Overexposure may trigger severe hypotension, neurologic impairment, gastrointestinal distress, methemoglobinemia, and potential circulatory collapse
Nitroglycerin is a type of Vasodilators
Vasodilators are a crucial subcategory of pharmaceutical Active Pharmaceutical Ingredients (APIs) that play a significant role in the management of various cardiovascular conditions. These medications work by widening the blood vessels, promoting increased blood flow and reducing peripheral resistance.
Vasodilators are commonly prescribed to treat hypertension (high blood pressure), angina (chest pain), and heart failure. They are designed to relax and dilate the smooth muscle cells in the walls of blood vessels, leading to improved circulation and reduced strain on the heart.
One widely used class of vasodilators is calcium channel blockers, which prevent calcium from entering the muscle cells of blood vessels. This action inhibits muscle contraction, resulting in widened arteries and enhanced blood flow. Another class is nitric oxide (NO) donors, which release NO, a potent vasodilator, to promote relaxation of vascular smooth muscles.
The therapeutic benefits of vasodilators extend beyond cardiovascular disorders. Some vasodilators, such as minoxidil, have been repurposed for treating male pattern baldness. These medications stimulate hair growth by dilating blood vessels around hair follicles, enhancing nutrient and oxygen delivery.
As with any pharmaceutical API, vasodilators must meet strict quality standards and regulatory guidelines to ensure safety and efficacy. Manufacturers employ sophisticated production processes and stringent quality control measures to guarantee the purity, potency, and stability of these APIs.
In conclusion, vasodilators are a vital subcategory of pharmaceutical APIs used to manage cardiovascular conditions. By expanding blood vessels and enhancing blood flow, vasodilators contribute to improved patient outcomes and play a critical role in the treatment of hypertension, angina, heart failure, and even hair loss.
Nitroglycerin (Vasodilators), classified under Antihypertensive agents
Antihypertensive agents are a crucial category of pharmaceutical active pharmaceutical ingredients (APIs) used to treat high blood pressure, also known as hypertension. These medications are designed to lower blood pressure and reduce the risk of associated cardiovascular complications.
Antihypertensive agents function by targeting various mechanisms involved in blood pressure regulation. Some common classes of antihypertensive agents include angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs), beta-blockers, calcium channel blockers (CCBs), and diuretics.
ACE inhibitors work by inhibiting the enzyme responsible for converting angiotensin I to angiotensin II, a hormone that constricts blood vessels. ARBs, on the other hand, block the receptors to which angiotensin II binds, thereby preventing its vasoconstrictive effects.
Beta-blockers reduce blood pressure by blocking the effects of adrenaline and noradrenaline, which are responsible for increasing heart rate and constricting blood vessels. CCBs inhibit calcium from entering the smooth muscles of blood vessels, resulting in relaxation and vasodilation. Diuretics promote the elimination of excess fluid and sodium from the body, reducing blood volume and thereby lowering blood pressure.
Antihypertensive agents are typically prescribed based on the individual patient's condition and specific needs. They can be used alone or in combination to achieve optimal blood pressure control. It is important to note that antihypertensive agents should be taken regularly as prescribed by a healthcare professional and may require periodic monitoring to ensure their effectiveness and manage any potential side effects.
In summary, antihypertensive agents play a vital role in the management of hypertension by targeting various mechanisms involved in blood pressure regulation. These medications offer significant benefits in reducing the risk of cardiovascular complications associated with high blood pressure.
Nitroglycerin API manufacturers & distributors
Compare qualified Nitroglycerin API suppliers worldwide. We currently have 1 companies offering Nitroglycerin API, with manufacturing taking place in 1 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 |
|---|---|---|---|---|---|
| PharmaZell | Producer | Germany | Germany | BSE/TSE, CEP, CoA, EDMF/ASMF, FDA, GDP, GMP, JDMF, MSDS, USDMF | 31 products |
When sending a request, specify which Nitroglycerin 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 Nitroglycerin 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 Nitroglycerin API
Sourcing
What matters most when sourcing GMP-grade Nitroglycerin?
Key factors include confirming GMP compliance and ensuring the manufacturer meets U.S. and Canadian regulatory expectations. Given the mature supply base, verifying the producer’s regulatory track record and consistency of quality systems is essential. It is also important to assess the control of repackaging steps, as repackaging is common in this market.
Which documents are typically required when sourcing Nitroglycerin API?
Request the core API documentation set: GDP (1 company), BSE/TSE (1 company), FDA (1 company), CoA (1 company), GMP (1 company). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Nitroglycerin API?
Known or reported manufacturers for Nitroglycerin: PharmaZell. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Nitroglycerin 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 Nitroglycerin manufacturers?
Audit reports may be requested for Nitroglycerin: 1 GMP audit report available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Nitroglycerin API on Pharmaoffer?
Reported supplier count for Nitroglycerin: 1 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Nitroglycerin API?
Production countries reported for Nitroglycerin: Germany (1 producer). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Nitroglycerin usually hold?
Common certifications for Nitroglycerin suppliers: GDP (1 company), BSE/TSE (1 company), FDA (1 company), CoA (1 company), GMP (1 company). Always verify issuing authorities and expiry dates when reviewing audit packages.
Technical
What is Nitroglycerin (CAS 55-63-0) used for?
Nitroglycerin is used as a vasodilator for acute and chronic management of angina pectoris and for cardiovascular situations requiring controlled reduction of preload and afterload. It is administered sublingually for rapid relief of acute angina, transdermally for longer-term prophylaxis, and intravenously for peri‑operative hypertension, acute heart failure associated with myocardial infarction, refractory angina, or induction of intraoperative hypotension. Topical formulations are used to relax the internal anal sphincter in chronic anal fissure.
Which therapeutic class does Nitroglycerin fall into?
Nitroglycerin belongs to the following therapeutic categories: Agents for Treatment of Hemorrhoids and Anal Fissures for Topical Use, Antianginal Agents, Antihypertensive Agents, Cardiac Therapy, Cardiovascular Agents. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Nitroglycerin mainly prescribed for?
The primary indications for Nitroglycerin: Sublingual Nitroglycerin is indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease, Transdermal Nitroglycerin is indicated for the prevention of angina pectoris due to coronary artery disease, Intravenous Nitroglycerin is indicated for the treatment of peri-operative hypertension. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Nitroglycerin work?
Nitroglycerin is converted by mitochondrial aldehyde dehydrogenase in smooth muscle cells to nitric oxide (NO), a potent vasodilator. NO activates the enzyme guanylate cyclase, which converts guanosine triphosphate (GTP) to cyclic guanosine 3',5'-monophosphate (cGMP) in vascular smooth muscle and other tissues.cGMP is an endogenous vasodilator of vascular smooth muscle:it causes protein kinase-dependent phosphorylation and activates downstream cascades that promote relaxation and increased blood flow in veins, arteries and cardiac tissue.An _in vitro_ study using mouse aorta suggests that nitric oxide, an active metabolite of Nitroglycerin, targets the natriuretic peptide receptors.
What should someone know about the safety or toxicity profile of Nitroglycerin?
Nitroglycerin has high acute toxicity in animal models, with low LD50 values emphasizing the need for controlled handling. Excess exposure can cause marked hypotension, neurologic symptoms, gastrointestinal distress, methemoglobinemia, or circulatory collapse. Clinically relevant adverse effects include headache, reflex tachycardia, and dose‑related blood pressure reduction. Continuous exposure may lead to tolerance, requiring nitrate‑free intervals to limit reduced responsiveness.
What are important formulation and handling considerations for Nitroglycerin as an API?
Nitroglycerin is a volatile, heat‑ and light‑sensitive liquid with low aqueous solubility, so formulations require protection from temperature excursions and photodegradation. The API can adsorb to plastics, making compatibility testing and selection of appropriate container–closure materials essential, particularly for parenteral and transdermal products. Its properties support use in sublingual, mucosal, transdermal, and IV dosage forms, each designed to control rapid absorption or sustained delivery while avoiding extensive first‑pass metabolism. Handling should maintain strict controls to preserve stability and prevent loss of potency.
Is Nitroglycerin a small molecule?
Nitroglycerin is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Nitroglycerin?
Oral and sublingual Nitroglycerin is sensitive to heat, light, and adsorption to certain plastics, so it requires packaging with compatible, light‑protective materials. Its volatility and low aqueous solubility also necessitate careful handling to prevent loss of drug content. These stability considerations are important to maintain dose accuracy and rapid mucosal absorption.
Regulatory
Where is Nitroglycerin approved or in use globally?
Nitroglycerin 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 Nitroglycerin right now?
Nitroglycerin is currently regulated and approved for use in both Canada and the United States. Specific regulatory pathways or recent changes are not provided in the available context. No patent information is included, so the current patent status cannot be described.
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Nitroglycerin procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Nitroglycerin. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Nitroglycerin included in the PRO Data Insights coverage?
PRO Data Insights coverage for Nitroglycerin: 736 verified transactions across 140 suppliers and 114 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Nitroglycerin?
Market report availability for Nitroglycerin: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.
