| CAS Number | 103-90-2 |
|---|---|
| Molecular Formula | C8H9NO2 |
| Molecular Weight | 151.17 |
| Pharmacopoeia | USP/CEP/EP |
| Packaging | 25 KG/DRUM |
Paracetamol (acetaminophen) was first synthesized in 1878 by American chemist Harmon Northrop Morse at Johns Hopkins University, though its clinical significance was not recognized at the time. The compound languished in obscurity until 1893, when German pharmacologist Joseph von Mering investigated it alongside phenacetin — a structurally related molecule. Von Mering mistakenly dismissed paracetamol as too toxic, recommending phenacetin instead, which became the dominant analgesic for the next 60 years.
The true mechanism of paracetamol was not elucidated until the 1970s. Unlike NSAIDs, paracetamol acts primarily as a central COX inhibitor, reducing prostaglandin synthesis in the brain and spinal cord while having negligible activity at peripheral inflammatory sites. It does not inhibit gastric prostaglandin production, which is why it avoids the gastrointestinal toxicity that limits chronic NSAID use. Recent research has also identified an indirect role in activating the endocannabinoid system, contributing to its analgesic effects.
Paracetamol's key advantage is its unmatched safety profile when dosed appropriately. At recommended therapeutic doses (maximum 4 g/day in adults), it has no adverse effects on the gastric mucosa, platelet function, or renal blood flow — unlike NSAIDs. This makes it the antipyretic and analgesic of choice for patients with gastric ulcers, bleeding disorders, and those on anticoagulant therapy. It is uniquely indicated across all age groups, from neonates to the elderly, and is the only analgesic recommended by WHO for fever following childhood vaccination.
As of mid-2026, the global paracetamol API market exceeds 200,000 metric tons annually, with China and India accounting for over 80% of global production. The API is a high-volume, cost-sensitive commodity, making supply chain reliability, batch-to-batch consistency, and competitive freight economics the defining differentiators between suppliers. KingWish supplies paracetamol API meeting USP, EP, CP, and CEP standards with the documentation packages required by pharmaceutical manufacturers in regulated markets.
| Purity (HPLC) | ≥ 99.0% (anhydrous basis), per USP/EP monograph |
|---|---|
| Related Substances | 4-Aminophenol impurity ≤ 50 ppm; any individual unspecified impurity ≤ 0.05% (USP) |
| Residual Solvents | Compliant with ICH Q3C; acetic acid ≤ 5,000 ppm |
| Heavy Metals | ≤ 10 ppm |
| GMP Status | Manufactured under ICH Q7 GMP conditions |
| Key Tests | Melting point 168-172 °C; loss on drying ≤ 0.5%; sulfated ash ≤ 0.1% |
Request CoA with HPLC purity, 4-aminophenol limit test, and residual solvent statement. For EU markets, verify CEP certificate validity with EDQM. Ensure the supplier can provide a Drug Master File or ASMF for regulatory filings.
Elevated 4-aminophenol content (potential hepatotoxicity signal), inconsistent particle size between batches, reluctance to share impurity profile, and prices significantly below market average — paracetamol is a low-margin commodity; extreme discounts often indicate non-GMP production.
Standard: 25 KG/DRUM. Specify particle size grade (fine, regular, or direct-compression). Verify humidity-controlled storage during maritime transport. Sea freight from major Chinese ports (Qingdao, Shanghai) typically 25-40 days to major destinations.
Global paracetamol API demand exceeds 200,000 MT/year, with China and India dominating production. Prices fluctuate seasonally with demand peaks during cold/flu season. CEP-certified material commands a 10-15% premium over standard-grade API. Market report