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Acetylsalicylic acid | CAS No: 50-78-2 | GMP-certified suppliers
A medication that addresses pain, fever, and inflammation while supporting antiplatelet use for reducing cardiovascular and cerebrovascular event risk across diverse clinical settings.
Therapeutic categories
Acids, CarbocyclicAgents causing angioedemaAgents causing hyperkalemiaAgents that produce hypertensionAlimentary Tract and MetabolismAnalgesics
Generic name
Acetylsalicylic acid
Molecule type
small molecule
CAS number
50-78-2
DrugBank ID
DB00945
Approval status
Approved drug, Vet_approved drug
ATC code
B01AC06
Primary indications
- Pain, fever, and inflammation**
- Acetylsalicylic acid (ASA), in the regular tablet form (immediate-release), is indicated to relieve pain, fever, and inflammation associated with many conditions, including the flu, the common cold, neck and back pain, dysmenorrhea, headache, tooth pain, sprains, fractures, myositis, neuralgia, synovitis, arthritis, bursitis, burns, and various injuries
- It is also used for symptomatic pain relief after surgical and dental procedures [FDA label]
- The _extra strength_ formulation of acetylsalicylic acid is also indicated for the management migraine pain with photophobia (sensitivity to light) and phonophobia (sensitivity to sound)[FDA label]
Product Snapshot
- Acetylsalicylic acid is an oral small‑molecule API available across immediate‑release, delayed‑release, extended‑release, and various topical and rectal presentations
- It is used for analgesic, antipyretic, anti‑inflammatory, and antiplatelet applications across broad symptomatic and cardiovascular indications
- It is approved in the US, Canada, and EU, including multiple human and veterinary registrations
Clinical Overview
Acetylsalicylic acid (ASA; CAS 50-78-2) is an acylated salicylic acid derivative used worldwide for the management of pain, fever, and inflammation. Immediate‑release oral formulations are applied across acute symptomatic conditions such as viral febrile illness, musculoskeletal pain, dysmenorrhea, dental and postoperative pain, and minor trauma. Higher‑strength products are used for migraine‑associated pain with photophobia and phonophobia. ASA is also widely used for antiplatelet therapy, including secondary prevention after myocardial infarction, unstable angina, ischemic stroke, and transient ischemic attack, and for prophylaxis in settings such as post–hip replacement thromboembolism and certain vascular procedures. Extended‑release formulations are intended for chronic cardiovascular risk reduction and are not appropriate for acute coronary syndromes, where rapid onset is required.
ASA exerts analgesic, antipyretic, and anti‑inflammatory effects through non‑selective inhibition of COX‑1 and COX‑2, reducing prostaglandin synthesis. Irreversible acetylation of COX‑1 in platelets suppresses thromboxane A2 formation and platelet aggregation for the lifespan of the platelet. COX‑2 inhibition requires higher doses and is less complete due to structural differences in the enzyme active site.
Absorption of ASA is generally prompt after oral administration, followed by rapid hydrolysis to salicylic acid. Both ASA and metabolites undergo hepatic conjugation and renal elimination. Protein binding of salicylate is concentration dependent, and clearance increases with urinary alkalinization. ASA crosses the placenta and is excreted in breast milk.
Major safety considerations include gastrointestinal irritation and bleeding, dose‑related renal effects, hypersensitivity reactions, and risk of Reye syndrome in children with viral illness. Overdose may cause metabolic acidosis and respiratory alkalosis. ASA interacts with other agents affecting coagulation, renal function, or protein binding.
Common global brands include Aspirin and various region‑specific generics and fixed‑dose combinations.
For API procurement, ensure compliance with pharmacopeial specifications, validated control of residual solvents and impurities, and robust stability data to support formulation and regulatory submissions.
ASA exerts analgesic, antipyretic, and anti‑inflammatory effects through non‑selective inhibition of COX‑1 and COX‑2, reducing prostaglandin synthesis. Irreversible acetylation of COX‑1 in platelets suppresses thromboxane A2 formation and platelet aggregation for the lifespan of the platelet. COX‑2 inhibition requires higher doses and is less complete due to structural differences in the enzyme active site.
Absorption of ASA is generally prompt after oral administration, followed by rapid hydrolysis to salicylic acid. Both ASA and metabolites undergo hepatic conjugation and renal elimination. Protein binding of salicylate is concentration dependent, and clearance increases with urinary alkalinization. ASA crosses the placenta and is excreted in breast milk.
Major safety considerations include gastrointestinal irritation and bleeding, dose‑related renal effects, hypersensitivity reactions, and risk of Reye syndrome in children with viral illness. Overdose may cause metabolic acidosis and respiratory alkalosis. ASA interacts with other agents affecting coagulation, renal function, or protein binding.
Common global brands include Aspirin and various region‑specific generics and fixed‑dose combinations.
For API procurement, ensure compliance with pharmacopeial specifications, validated control of residual solvents and impurities, and robust stability data to support formulation and regulatory submissions.
Identification & chemistry
| Generic name | Acetylsalicylic acid |
|---|---|
| Molecule type | Small molecule |
| CAS | 50-78-2 |
| UNII | R16CO5Y76E |
| DrugBank ID | DB00945 |
Pharmacology
| Summary | Acetylsalicylic acid irreversibly inhibits COX‑1 and, to a lesser extent, COX‑2, reducing prostaglandin and thromboxane A2 synthesis. This leads to decreased nociceptive and pyrogenic signaling and sustained suppression of platelet aggregation. Broader actions on cell‑signaling pathways have also been observed, contributing to ongoing investigation into its potential roles in cancer‑related mechanisms. |
|---|---|
| Mechanism of action | Acetylsalicylic acid (ASA) blocks prostaglandin synthesis. It is non-selective for COX-1 and COX-2 enzymes . Inhibition of COX-1 results in the inhibition of platelet aggregation for about 7-10 days (average platelet lifespan). The acetyl group of acetylsalicylic acid binds with a serine residue of the cyclooxygenase-1 (COX-1) enzyme, leading to irreversible inhibition. This prevents the production of pain-causing prostaglandins. This process also stops the conversion of arachidonic acid to thromboxane A2 (TXA2), which is a potent inducer of platelet aggregation [FDA label]. Platelet aggregation can result in clots and harmful venous and arterial thromboembolism, leading to conditions such as pulmonary embolism and stroke. It is important to note that there is 60% homology between the protein structures of COX-1 and COX-2. ASA binds to serine 516 residue on the active site of COX-2 in the same fashion as its binding to the serine 530 residue located on the active site of COX-1. The active site of COX-2 is, however, slightly larger than the active site of COX-1, so that arachidonic acid (which later becomes prostaglandins) manages to bypass the aspirin molecule inactivating COX-2 . ASA, therefore, exerts more action on the COX-1 receptor rather than on the COX-2 receptor . A higher dose of acetylsalicylic acid is required for COX-2 inhibition . |
| Pharmacodynamics | **Effects on pain and fever** Acetylsalicylic acid disrupts the production of prostaglandins throughout the body by targeting cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2) . Prostaglandins are potent, irritating substances that have been shown to cause headaches and pain upon injection into humans. Prostaglandins increase the sensitivity of pain receptors and substances such as histamine and bradykinin. Through the disruption of the production and prevention of release of prostaglandins in inflammation, this drug may stop their action at pain receptors, preventing symptoms of pain. Acetylsalicylic acid is considered an antipyretic agent because of its ability to interfere with the production of brain prostaglandin E1. Prostaglandin E1 is known to be an extremely powerful fever-inducing agent [FDA label]. **Effects on platelet aggregation** The inhibition of platelet aggregation by ASA occurs because of its interference with thromboxane A2 in platelets, caused by COX-1 inhibition. Thromboxane A2 is an important lipid responsible for platelet aggregation, which can lead to clot formation and future risk of heart attack or stroke [FDA label]. **A note on cancer prevention** ASA has been studied in recent years to determine its effect on the prevention of various malignancies . In general, acetylsalicylic acid is involved in the interference of various cancer signaling pathways, sometimes inducing or upregulating tumor suppressor genes . Results of various studies suggest that there are beneficial effects of long-term ASA use in the prevention of several types of cancer, including stomach, colorectal, pancreatic, and liver cancers . Research is ongoing. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Prostaglandin G/H synthase 1 | Humans | inhibitor |
| Prostaglandin G/H synthase 2 | Humans | inhibitor |
| Aldo-keto reductase family 1 member C1 | Humans | inhibitor |
ADME / PK
| Absorption | Absorption is generally rapid and complete following oral administration but absorption may be variable depending on the route, dosage form, and other factors including but not limited to the rate of tablet dissolution, gastric contents, gastric emptying time, and gastric pH [FDA label]. **Detailed absorption information** When ingested orally, acetylsalicylic acid is rapidly absorbed in both the stomach and proximal small intestine. The non-ionized acetylsalicylic acid passes through the stomach lining by passive diffusion. Ideal absorption of salicylate in the stomach occurs in the pH range of 2.15 - 4.10. Intestinal absorption of acetylsalicylic acid occurs at a much faster rate. At least half of the ingested dose is hydrolyzed to salicylic acid in the first-hour post-ingestion by esterases found in the gastrointestinal tract. Peak plasma salicylate concentrations occur between 1-2 hours post-administration [FDA label]. |
|---|---|
| Half-life | The half-life of ASA in the circulation ranges from 13 - 19 minutes. Blood concentrations drop rapidly after complete absorption. The half-life of the salicylate ranges between 3.5 and 4.5 hours [FDA label]. |
| Protein binding | 50% to 90% of a normal therapeutic concentration salicylate (a main metabolite of acetylsalicylic acid [FDA label]) binds plasma proteins, particularly albumin, while acetylsalicylic acid itself binds negligibly [FDA label]. Acetylsalicylic acid has the ability to bind to and acetylate many proteins, hormones, DNA, platelets, and hemoglobin [FDA label]. |
| Metabolism | Acetylsalicylic acid is hydrolyzed in the plasma to salicylic acid. Plasma concentrations of aspirin following after administration of the extended-release form are mostly undetectable 4-8 hours after ingestion of a single dose. Salicylic acid was measured at 24 hours following a single dose of extended-release acetylsalicylic acid . Salicylate is mainly metabolized in the liver, although other tissues may also be involved in this process [FDA label]. The major metabolites of acetylsalicylic acid are salicylic acid, salicyluric acid, the ether or phenolic glucuronide and the ester or acyl glucuronide. A small portion is converted to gentisic acid and other hydroxybenzoic acids [FDA label]. |
| Route of elimination | Excretion of salicylates occurs mainly through the kidney, by the processes of glomerular filtration and tubular excretion, in the form of free salicylic acid, salicyluric acid, and, additionally, phenolic and acyl glucuronides [FDA label]. Salicylate can be found in the urine soon after administration, however, the entire dose takes about 48 hours to be completely eliminated. The rate of salicylate is often variable, ranging from 10% to 85% in the urine, and heavily depends on urinary pH. Acidic urine generally aids in reabsorption of salicylate by the renal tubules, while alkaline urine increases excretion [FDA label]. After the administration of a typical 325mg dose, the elimination of ASA is found to follow first order kinetics in a linear fashion. At high concentrations, the elimination half-life increases [FDA label]. |
| Volume of distribution | This drug is distributed to body tissues shortly after administration. It is known to cross the placenta. The plasma contains high levels of salicylate, as well as tissues such as spinal, peritoneal and synovial fluids, saliva and milk. The kidney, liver, heart, and lungs are also found to be rich in salicylate concentration after dosing. Low concentrations of salicylate are usually low, and minimal concentrations are found in feces, bile, and sweat [FDA label]. |
| Clearance | The clearance rate of acetylsalicylic acid is extremely variable, depending on several factors . Dosage adjustments may be required in patients with renal impairment [FDA label]. The extended-release tablet should not be administered to patients with eGFR of less than 10 mL/min . |
Formulation & handling
- Oral formulations dominate and benefit from enteric coating to limit gastric hydrolysis and reduce upper‑GI irritation.
- The small‑molecule API is moisture‑ and heat‑labile, requiring dry, cool handling to prevent conversion to salicylic acid.
- Reconstitution of parenteral powders should minimize exposure to alkaline media because ester cleavage accelerates under basic conditions.
Regulatory status
| Lifecycle | The API shows a mixed maturity profile, with several U.S. patents expiring between 2017 and 2023 supporting an established market presence in the US, Canada, and the EU. A remaining U.S. patent extending to 2032 indicates ongoing protection for certain aspects of the product. |
|---|
| Markets | US, Canada, EU |
|---|
Supply Chain
| Supply chain summary | Acetylsalicylic acid is supplied by a single originator manufacturer, with a broad network of packagers supporting distribution across the US, Canada, and the EU. Branded products have long-standing global availability, and many key US patents have already expired, indicating an established presence of generics. A remaining patent extending to 2032 may relate to specific formulations, but it does not limit overall generic competition for the core API. |
|---|
Safety
| Toxicity | **Lethal doses** Acute oral LD50 values have been reported as over 1.0 g/kg in humans, cats, and dogs, 0.92 g/kg - 1.48 g/kg in albino rats, 1.19 g/kg in guinea pigs, 1.1 g/kg in mice, and 1.8 g/kg in rabbit models [FDA label]. **Acute toxicity** Salicylate toxicity is a problem that may develop with both acute and chronic salicylate exposure . Multiple organ systems may be affected by salicylate toxicity, including the central nervous system, the pulmonary system, and the gastrointestinal system. Severe bleeding may occur. In the majority of cases, patients suffering from salicylate toxicity are volume-depleted at the time of presentation for medical attention. Fluid resuscitation should occur immediately and volume status should be monitored closely. Disruptions in acid-base balance are frequent in ASA toxicity . The acute toxicity of acetylsalicylic in animals has been widely studied. The signs of poisoning in rats from lethal doses are mild to severe gastroenteritis, hepatitis, nephritis, pulmonary edema, encephalopathy, shock and some toxic effects on other organs and tissues. Mortality has been observed following convulsions or cardiovascular shock. An important differentiating property between various animal species is the ability to vomit toxic doses. Humans, cats and dogs have this ability, but rodents or rabbits do not [FDA label]. **Chronic toxicity and carcinogenesis** Chronic ASA toxicity is frequently accompanied by atypical clinical presentations that may be similar to diabetic ketoacidosis, delirium, cerebrovascular accident (CVA), myocardial infarction (MI) or cardiac failure. Plasma salicylate concentrations should be measured if salicylate intoxication is suspected, even if there no documentation available to suggest ASA was ingested. In older age, nephrotoxicity from salicylates increases, and the risk of upper gastrointestinal hemorrhage is increased, with higher rates of mortality . It is also important to note that ASA toxicity may occur even with close to normal serum concentrations. Prevention of chronic ASA includes the administration of smallest possible doses, avoidance of concurrent use of salicylate drugs, and therapeutic drug monitoring. Renal function should be regularly monitored and screening for gastrointestinal bleeding should be done at regular intervals . Chronic toxicity studies were performed in rodents. ASA was administered at doses measured to be 2 to 20 times the maximum tolerated clinical dose to mice for up to one year. Negative dose-related effects were seen. These include decreased mean survival time, decreased number of births and progeny reaching an appropriate age for weaning. No evidence of carcinogenesis was found in 1-year studies [FDA label]. At daily doses of 0.24 g/kg/day given for 100 days to albino rats, ASA led to signs to excessive thirst, aciduria, diuresis, drowsiness, hyperreflexia, piloerection, changes in respiration, tachycardia, followed by soft stools, epistaxis, sialorrhea, dacryorrhea and mortality during hypothermic coma in the second study month [FDA label]. **Use in pregnancy and lactation** While teratogenic effects were observed in animals nearly lethal doses, no evidence suggests that this drug is teratogenic in humans [FDA label]. It is advisable, however, to avoid ASA use the first and second trimester of pregnancy, unless it is clearly required. If acetylsalicylic acid containing drugs are ingested by a patient attempting to conceive, or during the first and second trimester of pregnancy, the lowest possible dose at the shortest possible duration should be taken [FDA label]. This drug is contraindicated in the 3rd trimester of pregnancy [FDA label]. |
|---|
High Level Warnings:
- High acute LD50 values (›1 g/kg in several species) indicate relatively low single‑dose lethality, but toxic exposures can produce multi‑organ effects including gastroenteritis, hepatic and renal injury, pulmonary edema, and CNS disturbances
- Species‑dependent emesis capability influences toxicokinetics
- Rodents and rabbits lack a vomiting reflex and show higher susceptibility to lethal outcomes such as convulsions or cardiovascular collapse
Acetylsalicylic acid is a type of NSAIDs
NSAIDs (Non-Steroidal Anti-Inflammatory Drugs) are a widely used subcategory of pharmaceutical Active Pharmaceutical Ingredients (APIs). These medications are commonly prescribed for their analgesic (pain-relieving), anti-inflammatory, and antipyretic (fever-reducing) properties. NSAIDs work by inhibiting the production of certain enzymes called cyclooxygenases (COX), which play a crucial role in the synthesis of prostaglandins, substances that contribute to pain, inflammation, and fever.
These pharmaceutical APIs are available in various formulations, including tablets, capsules, creams, and gels, making them convenient for different administration routes. Some popular examples of NSAIDs include aspirin, ibuprofen, naproxen, and diclofenac.
NSAIDs are commonly used to treat a wide range of conditions such as arthritis, musculoskeletal injuries, dental pain, menstrual pain, and headaches. They are also effective in managing inflammatory conditions like rheumatoid arthritis and ankylosing spondylitis.
While NSAIDs are generally safe and effective when used as directed, they may have side effects. These can include gastrointestinal issues such as stomach ulcers or bleeding, cardiovascular risks, and kidney problems. Therefore, it is essential to follow the recommended dosage and consult with healthcare professionals to ensure proper and safe usage.
In conclusion, NSAIDs are a subcategory of pharmaceutical APIs that offer analgesic, anti-inflammatory, and antipyretic properties. Their versatility and effectiveness in treating various conditions make them widely prescribed medications. However, it is crucial to be aware of potential side effects and consult healthcare providers for appropriate usage.
Acetylsalicylic acid (NSAIDs), classified under Anti-inflammatory Agents
Anti-inflammatory agents are a crucial category of pharmaceutical active pharmaceutical ingredients (APIs) used to treat various inflammatory conditions. These agents play a vital role in alleviating pain, reducing swelling, and controlling inflammation in the body. They are widely employed in the management of diverse medical conditions, including arthritis, autoimmune disorders, asthma, and skin conditions like dermatitis.
Anti-inflammatory APIs primarily function by inhibiting the production of specific enzymes called cyclooxygenases (COX) and lipoxygenases (LOX). These enzymes are responsible for the synthesis of pro-inflammatory molecules known as prostaglandins and leukotrienes, respectively. By suppressing the activity of COX and LOX, anti-inflammatory agents effectively curtail the production of these inflammatory mediators, thereby mitigating inflammation.
Common examples of anti-inflammatory APIs include non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen, aspirin, and naproxen. These agents exhibit analgesic, antipyretic, and anti-inflammatory properties. Another group of anti-inflammatory APIs includes corticosteroids, such as prednisone and dexamethasone, which are synthetic hormones that modulate the body's immune response to control inflammation.
In conclusion, anti-inflammatory agents are a vital category of pharmaceutical APIs widely used to manage inflammation-related disorders. They target enzymes involved in the synthesis of pro-inflammatory molecules, effectively reducing pain and swelling. NSAIDs and corticosteroids are commonly prescribed anti-inflammatory APIs due to their efficacy in controlling inflammation.
Acetylsalicylic acid API manufacturers & distributors
Compare qualified Acetylsalicylic acid API suppliers worldwide. We currently have 15 companies offering Acetylsalicylic acid API, with manufacturing taking place in 6 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 |
|---|---|---|---|---|---|
| Arshine Pharmaceutical Co... | Distributor | China | China | BSE/TSE, CEP, CoA, EDMF/ASMF, FDA, GDP, GMP, ISO9001, JDMF, KDMF, MSDS, USDMF, WC, WHO-GMP | 176 products |
| Aurora Industry Co., Ltd | Distributor | China | China | BSE/TSE, CEP, CoA, EDMF/ASMF, FDA, GMP, HALAL, ISO9001, Kosher, MSDS, USDMF, WC | 250 products |
| Bayer | Producer | Germany | Unknown | CoA, USDMF | 42 products |
| Bayer Hispania | Producer | Spain | Spain | CEP, CoA, FDA, GMP | 2 products |
| Caesar & Loretz GmbH (CAE... | Distributor | Germany | Unknown | BSE/TSE, CoA, GMP, ISO9001, MSDS | 211 products |
| Chr. Olesen Group | Distributor | Denmark | China | CEP, CoA, GMP, MSDS, USDMF | 252 products |
| Hunan Yuxin Pharmaceutica... | Producer | China | China | CoA | 14 products |
| Indukern Chemie AG | Distributor | Switzerland | Unknown | CoA | 13 products |
| JQC (Huayin) Pharmaceutic... | Producer | China | China | CoA | 8 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| Pharm Rx Chemical Corp | Distributor | United States | China | BSE/TSE, CoA, GMP, MSDS, USDMF | 166 products |
| Rochem International, Inc... | Distributor | United States | United States | BSE/TSE, CoA, GMP, ISO9001, MSDS | 144 products |
| Shandong Xinhua | Producer | China | China | CEP, CoA, FDA, GMP, USDMF, WC | 21 products |
| The Andhra Sugars | Producer | India | India | CEP, CoA, FDA, USDMF, WC | 1 products |
| Unnati Pharmaceuticals Pv... | Distributor | India | India | CoA | 70 products |
When sending a request, specify which Acetylsalicylic acid 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 Acetylsalicylic acid 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 Acetylsalicylic acid API
Sourcing
What matters most when sourcing GMP-grade Acetylsalicylic acid?
Key considerations include confirming GMP compliance and ensuring the API meets regulatory requirements for the US, Canada, and the EU. Because a single originator manufacturer supplies the API, verifying supply chain transparency and packager qualifications is important. Established generic availability and the remaining formulation‑related patent indicate that sourcing the core API is not restricted, but documentation should clearly distinguish API compliance from any formulation‑specific protections.
Which documents are typically required when sourcing Acetylsalicylic acid API?
Request the core API documentation set: CoA (15 companies), GMP (9 companies), USDMF (8 companies), CEP (7 companies), MSDS (7 companies). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Acetylsalicylic acid API?
Known or reported manufacturers for Acetylsalicylic acid: Caesar & Loretz GmbH (CAELO), Chr. Olesen Group, Aurora Industry Co., Ltd, Pharm Rx Chemical Corp, Arshine Pharmaceutical Co., Limited, LGM Pharma, Rochem International, Inc.. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Acetylsalicylic acid 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 Acetylsalicylic acid manufacturers?
Audit reports may be requested for Acetylsalicylic acid: 5 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Acetylsalicylic acid API on Pharmaoffer?
Reported supplier count for Acetylsalicylic acid: 15 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Acetylsalicylic acid API?
Production countries reported for Acetylsalicylic acid: China (7 producers), 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 Acetylsalicylic acid usually hold?
Common certifications for Acetylsalicylic acid suppliers: CoA (15 companies), GMP (9 companies), USDMF (8 companies), CEP (7 companies), MSDS (7 companies). Always verify issuing authorities and expiry dates when reviewing audit packages.
Technical
What is Acetylsalicylic acid (CAS 50-78-2) used for?
Acetylsalicylic acid is used as an analgesic, antipyretic, and anti‑inflammatory agent for conditions such as musculoskeletal pain, fever, dysmenorrhea, dental and postoperative pain, minor trauma, and migraine‑associated pain. It is also used as an antiplatelet agent for secondary prevention after myocardial infarction, unstable angina, ischemic stroke, and transient ischemic attack, and for thromboprophylaxis in selected surgical and vascular settings. Different formulations support acute symptomatic treatment or chronic cardiovascular risk reduction.
Which therapeutic class does Acetylsalicylic acid fall into?
Acetylsalicylic acid belongs to the following therapeutic categories: Acids, Carbocyclic, Agents causing angioedema, Agents causing hyperkalemia, Agents that produce hypertension, Alimentary Tract and Metabolism. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Acetylsalicylic acid mainly prescribed for?
The primary indications for Acetylsalicylic acid: Pain, fever, and inflammation**, Acetylsalicylic acid (ASA), in the regular tablet form (immediate-release), is indicated to relieve pain, fever, and inflammation associated with many conditions, including the flu, the common cold, neck and back pain, dysmenorrhea, headache, tooth pain, sprains, fractures, myositis, neuralgia, synovitis, arthritis, bursitis, burns, and various injuries, It is also used for symptomatic pain relief after surgical and dental procedures [FDA label], The _extra strength_ formulation of Acetylsalicylic acid is also indicated for the management migraine pain with photophobia (sensitivity to light) and phonophobia (sensitivity to sound)[FDA label]. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Acetylsalicylic acid work?
Acetylsalicylic acid (ASA) blocks prostaglandin synthesis. It is non-selective for COX-1 and COX-2 enzymes . Inhibition of COX-1 results in the inhibition of platelet aggregation for about 7-10 days (average platelet lifespan). The acetyl group of Acetylsalicylic acid binds with a serine residue of the cyclooxygenase-1 (COX-1) enzyme, leading to irreversible inhibition. This prevents the production of pain-causing prostaglandins. This process also stops the conversion of arachidonic acid to thromboxane A2 (TXA2), which is a potent inducer of platelet aggregation [FDA label]. Platelet aggregation can result in clots and harmful venous and arterial thromboembolism, leading to conditions such as pulmonary embolism and stroke.
It is important to note that there is 60% homology between the protein structures of COX-1 and COX-2. ASA binds to serine 516 residue on the active site of COX-2 in the same fashion as its binding to the serine 530 residue located on the active site of COX-1. The active site of COX-2 is, however, slightly larger than the active site of COX-1, so that arachidonic acid (which later becomes prostaglandins) manages to bypass the aspirin molecule inactivating COX-2 . ASA, therefore, exerts more action on the COX-1 receptor rather than on the COX-2 receptor . A higher dose of Acetylsalicylic acid is required for COX-2 inhibition .
What should someone know about the safety or toxicity profile of Acetylsalicylic acid?
Acetylsalicylic acid has a well‑characterized safety profile that includes gastrointestinal irritation and bleeding, dose‑related renal effects, hypersensitivity reactions, and a risk of Reye syndrome in children with viral illness. Toxic exposures can lead to metabolic acidosis, respiratory alkalosis, and multi‑organ effects such as gastroenteritis, hepatic and renal injury, pulmonary edema, and CNS disturbances. High acute LD50 values indicate relatively low single‑dose lethality, but species differences in emesis and toxicokinetics influence outcomes. ASA also interacts with drugs that affect coagulation, renal function, or protein binding.
What are important formulation and handling considerations for Acetylsalicylic acid as an API?
Acetylsalicylic acid is moisture‑ and heat‑labile, so it should be handled and stored in dry, cool conditions to limit hydrolysis to salicylic acid. Oral formulations often use enteric coating to reduce gastric hydrolysis and upper‑GI irritation. For parenteral powders, reconstitution should avoid alkaline media because ester cleavage increases under basic conditions.
Is Acetylsalicylic acid a small molecule?
Acetylsalicylic acid is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Acetylsalicylic acid?
Oral Acetylsalicylic acid is prone to moisture‑ and heat‑driven hydrolysis to salicylic acid, so it requires dry, cool storage and handling. Hydrolysis also increases in alkaline environments, making protection from elevated pH important. Enteric coating is commonly used to limit gastric hydrolysis and reduce upper‑GI irritation.
Regulatory
Where is Acetylsalicylic acid approved or in use globally?
Acetylsalicylic acid is reported as approved in the following major regions: US, Canada, EU. Understanding geographic coverage informs regulatory filings, supply planning, and risk assessments before escalating procurement.
What’s the regulatory and patent landscape for Acetylsalicylic acid right now?
Acetylsalicylic acid is an established, widely approved active ingredient in the US, Canada, and the EU for various nonprescription and prescription uses. It is regulated under standard monograph or generic pathways in these regions. All known primary patents and data exclusivities have long expired, and it is produced and marketed by multiple manufacturers without proprietary protection.
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Acetylsalicylic acid procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Acetylsalicylic acid. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Acetylsalicylic acid included in the PRO Data Insights coverage?
PRO Data Insights coverage for Acetylsalicylic acid: 798 verified transactions across 194 suppliers and 113 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Acetylsalicylic acid?
Market report availability for Acetylsalicylic acid: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.
