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Salsalate | CAS No: 552-94-3 | GMP-certified suppliers
A medication that provides relief of symptoms associated with rheumatoid arthritis, osteoarthritis, and related rheumatic disorders to support consistent anti-inflammatory treatment requirements.
Therapeutic categories
Primary indications
- For relief of the signs and symptoms of rheumatoid arthritis, osteoarthritis and related rheumatic disorders
Product Snapshot
- Oral small‑molecule formulation supplied as standard and film‑coated tablets
- Used for symptomatic management of rheumatoid arthritis, osteoarthritis, and related rheumatic conditions
- Approved and commercially available in the US and Canada
Clinical Overview
Its pharmacological activity is primarily attributed to prostaglandin synthesis inhibition. Salsalate and its active metabolite, salicylic acid, reduce inflammatory mediators through functional inactivation of cyclooxygenase‑1 and cyclooxygenase‑2 in the arachidonic acid pathway. Although salicylic acid is a relatively weak in vitro prostaglandin inhibitor, in vivo exposure following salsalate administration provides anti‑inflammatory effects comparable to other traditional non‑selective NSAIDs. Unlike aspirin, salsalate does not inhibit platelet aggregation, a distinction relevant for patients requiring anti‑inflammatory therapy without antiplatelet effects.
After oral dosing, salsalate dissolves readily in the small intestine, where it undergoes partial hydrolysis to two molecules of salicylic acid. A substantial fraction is absorbed unchanged and subsequently hydrolyzed by esterases. The parent compound has an elimination half‑life of approximately one hour. Salicylic acid exhibits capacity‑limited metabolism at therapeutic anti‑inflammatory exposures, leading to a prolonged half‑life that may range from about 3.5 hours to 16 hours or more. These nonlinear kinetics should be considered during chronic dosing.
Safety considerations include typical NSAID‑associated risks, with particular attention to renal effects given its classification among nephrotoxic agents. Salsalate has been noted to produce gastrointestinal tolerability comparable to placebo with respect to fecal blood loss. However, standard NSAID precautions apply, including monitoring for renal function changes, salicylate accumulation, and potential alterations in potassium homeostasis.
Salsalate is marketed in multiple regions, commonly as oral tablets used in rheumatologic practice. For API procurement, sourcing should prioritize consistent impurity profiles, validated hydrolysis behavior, and compliance with pharmacopeial specifications to support reliable formulation performance and regulatory acceptance.
Identification & chemistry
| Generic name | Salsalate |
|---|---|
| Molecule type | Small molecule |
| CAS | 552-94-3 |
| UNII | V9MO595C9I |
| DrugBank ID | DB01399 |
Pharmacology
| Summary | Salsalate is a nonsteroidal anti‑inflammatory drug that reduces inflammatory signaling primarily by inhibiting COX‑1 and COX‑2, decreasing prostaglandin synthesis in the arachidonic acid pathway. Its activity is mediated through its metabolite salicylic acid, which provides anti‑inflammatory effects comparable to other salicylates while having minimal impact on platelet aggregation. The drug is used to address inflammatory symptoms associated with rheumatoid arthritis, osteoarthritis, and related rheumatic conditions. |
|---|---|
| Mechanism of action | The mode of anti-inflammatory action of salsalate and other nonsteroidal anti-inflammatory drugs is not fully defined, but appears to be primarily associated with inhibition of prostaglandin synthesis. This inhibition of prostaglandin synthesis is done through the inactivation of cyclooxygenase-1 (COX-1) and COX-2, which are reponsible for catalyzing the formation of prostaglandins in the arachidonic acid pathway. Although salicylic acid (the primary metabolite of salsalate) is a weak inhibitor of prostaglandin synthesis in vitro, salsalate appears to selectively inhibit prostaglandin synthesis in vivo, providing anti-inflammatory activity equivalent to aspirin and indomethacin. Unlike aspirin, salsalate does not inhibit platelet aggregation. |
| Pharmacodynamics | Salsalate is a nonsteroidal anti-inflammatory agent for oral administration. Salsalate's mode of action as an anti-inflammatory and antirheumatic agent may be due to inhibition of synthesis and release of prostaglandins. The usefulness of salicylic acid, the active in vivo product of salsalate, in the treatment of arthritic disorders has been established. In contrast to aspirin, salsalate causes no greater fecal gastrointestinal blood loss than placebo. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Prostaglandin G/H synthase 2 | Humans | inhibitor |
| Prostaglandin G/H synthase 1 | Humans | inhibitor |
ADME / PK
| Absorption | Salsalate is insoluble in acid gastric fluids (< 0.1 mg/ml at pH 1.0), but readily soluble in the small intestine where it is partially hydrolyzed to two molecules of salicylic acid. A significant portion of the parent compound is absorbed unchanged. The amount of salicylic acid available from salsalate is about 15% less than from aspirin, when the two drugs are administered on a salicylic acid molar equivalent basis (3.6 g salsalate/5 g aspirin). Food slows the absorption of all salicylates including salsalate. |
|---|---|
| Half-life | The parent compound has an elimination half-life of about 1 hour. Salicylic acid (the active metabolite) biotransformation is saturated at anti-inflammatory doses of salsalate. Such capacity limited biotransformation results in an increase in the half-life of salicylic acid from 3.5 to 16 or more hours. |
| Protein binding | Salicylate: 90-95% bound at plasma salicylate concentrations <100 mcg/mL; 70-85% bound at concentrations of 100-400 mcg/mL; 25-60% bound at concentrations >400 mcg/mL. |
| Metabolism | Salsalate is readily soluble in the small intestine where it is partially hydrolyzed to two molecules of salicylic acid. A significant portion of the parent compound is absorbed unchanged and undergoes rapid esterase hydrolysis in the body. |
Formulation & handling
- Oral small‑molecule API with low aqueous solubility, typically formulated as solid tablets; may require particle‑size control or dispersion strategies to optimize dissolution.
- Food has minimal impact on overall exposure, but coadministration with food can slow absorption, which is not usually formulation‑limiting.
- Handle as a solid organic acid derivative; avoid moisture uptake during processing and consider enteric or film coating to mitigate gastric irritation potential.
Regulatory status
| Lifecycle | Patent‑expiry information for this API is not provided, but with commercialization in the US and Canada—both mature, highly genericized markets—the product is likely in a late or post‑exclusivity stage. Market dynamics in these regions typically reflect established competition and stable demand. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Salsalate originated from a single brand (Disalcid), but the current supply landscape is dominated by numerous repackagers and generic manufacturers, indicating a mature and commoditized market. Branded products have historically been available in the US and Canada, though today the market is largely supplied through generics. Patent expiry occurred long ago, and extensive generic competition is already established. |
|---|
Safety
| Toxicity | Death has followed ingestion of 10 to 30 g of salicylates in adults, but much larger amounts have been ingested without fatal outcome. |
|---|
- High acute oral toxicity: adult fatalities have been reported after ingestion of roughly 10–30 g of salicylates
- Exhibits wide interindividual variability in toxic response, with some cases tolerating substantially higher exposures without fatality
- Requires controls to prevent accidental high-dose exposure during manufacturing and handling due to narrow margin between therapeutic and toxic systemic levels
US Drug Master File (USDMF)
A US Drug Master File (USDMF) is a confidential document submitted to the U.S. Food and Drug Administration (FDA) that provides detailed information about the manufacturing process of an Active Pharmaceutical Ingredient (API) or a finished pharmaceutical product. This document includes comprehensive details such as chemical properties, manufacturing facilities, production processes, packaging specifications, storage conditions, and more.
The USDMF ensures that proprietary information remains protected while allowing the FDA to review the data as part of drug approval processes. Unlike other types of DMFs used in different regions, the USDMF is specifically designed to meet the regulatory requirements set by the FDA, ensuring compliance with U.S. standards.
Salsalate 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.
Salsalate (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.
Salsalate API manufacturers & distributors
Compare qualified Salsalate API suppliers worldwide. We currently have 5 companies offering Salsalate 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 |
|---|---|---|---|---|---|
| Kreative Organics | Producer | India | India | CoA, GMP, USDMF, WC | 9 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| Pharm Rx Chemical Corp | Distributor | United States | India | BSE/TSE, CoA, GMP, MSDS, USDMF | 166 products |
| Raks Pharma | Producer | India | India | CoA, USDMF | 58 products |
| Wanbury | Producer | India | India | CoA, USDMF | 15 products |
When sending a request, specify which Salsalate 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 Salsalate 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 Salsalate API
Sourcing
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Technical
What is Salsalate (CAS 552-94-3) used for?
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Regulatory
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Pharmaoffer
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