Aspirin

As a classic antipyretic and analgesic drug with more than a hundred years of clinical application, aspirin falls into the category of non-steroidal anti-inflammatory drugs (NSAIDs). By irreversibly inhibiting the activity of cyclooxygenase (COX), it reduces the synthesis of prostaglandins and thromboxane A2, and has multiple effects of antipyretic, analgesic, anti-inflammatory and anti-platelet aggregation. At the clinical level, low-dose aspirin is commonly used for the secondary prevention of cardiovascular and cerebrovascular events such as myocardial infarction and ischemic stroke. Conventional-dose aspirin can relieve mild to moderate pain such as headache, toothache and arthralgia, and can also be used for symptom control of rheumatic arthritis and rheumatoid arthritis. Its applicable population covers multiple groups such as people at high risk of cardiovascular and cerebrovascular diseases and patients with inflammatory pain, making it one of the most widely used basic medicines worldwide.

At present, the global market size of aspirin is stable at more than 2 billion US dollars, among which the clinical demand for the anti-platelet aggregation indication accounts for more than 60%. As the largest producer of aspirin active pharmaceutical ingredients (APIs) in the world, China has an annual output of more than 20,000 tons, accounting for more than 70% of the total global output. The industry concentration is relatively high, and the production capacity of leading enterprises accounts for 80% of the total domestic production capacity. Due to its long marketing history, this variety has fully entered the generic stage, and the domestic preparation market is highly competitive. Dozens of product specifications have passed the quality and efficacy consistency evaluation of generic drugs, and the terminal price in primary medical institutions is stable at about 0.05 yuan per tablet, with extremely high clinical accessibility.

The original research enterprise of aspirin is Bayer AG of Germany, and the original brand name is "Bayaspirin". The core compound patent expired globally in 1918. The mainstream dosage forms of the original product include 100mg enteric-coated tablets, 500mg conventional tablets, etc. Among them, the 100mg enteric-coated tablet has been included in the *Catalogue of Reference Preparations for Chemical Drugs* of China, and is also a reference preparation recognized by the FDA. In terms of domestic API registration, more than 30 enterprises have obtained CDE registration numbers for their aspirin APIs, among which more than 20 are in A status, which can be legally supplied for domestic preparation production. The domestically approved aspirin preparations marketed cover multiple dosage forms such as enteric-coated tablets, sustained-release tablets, effervescent tablets and suppositories, meeting the needs of different clinical scenarios. (Data as of October 2024, please refer to the official CDE website for the latest information)

In response to the demand for aspirin-related quality research, CATO can provide a full set of impurity reference standards for this API. Most products are in stock, and orders for in-stock products placed before 16:00 will be shipped on the same day. All reference standards comply with the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can directly support various research scenarios such as API quality control and generic drug consistency evaluation.