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Paracetamol (Acetaminophen)

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Paracetamol (Acetaminophen) pharmaceutical raw material
Quick Facts
CAS Number103-90-2
Molecular FormulaC8H9NO2
Molecular Weight151.17
PharmacopoeiaUSP/CEP/EP
Packaging25 KG/DRUM
USP Standard EP/BP Standard

Product Story

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.

Quality Specifications

Purity (HPLC)≥ 99.0% (anhydrous basis), per USP/EP monograph
Related Substances4-Aminophenol impurity ≤ 50 ppm; any individual unspecified impurity ≤ 0.05% (USP)
Residual SolventsCompliant with ICH Q3C; acetic acid ≤ 5,000 ppm
Heavy Metals≤ 10 ppm
GMP StatusManufactured under ICH Q7 GMP conditions
Key TestsMelting point 168-172 °C; loss on drying ≤ 0.5%; sulfated ash ≤ 0.1%

Pharmaceutical Applications

  • Analgesic: First-line for mild to moderate pain including headache, dental pain, osteoarthritis, and dysmenorrhea. Standard dose: 500-1000 mg every 4-6 hours.
  • Antipyretic: Antipyretic of choice for fever management across all age groups. Preferred over ibuprofen in patients with gastric sensitivity or bleeding risk.
  • Post-vaccination fever: WHO-recommended prophylactic agent for fever and local reactions following routine childhood immunizations.
  • Combination formulations: Paired with opioids (codeine, tramadol) for moderate to severe pain, and with decongestants/antihistamines in cold and flu products.
  • Post-operative pain: Integral component of multimodal analgesia regimens, reducing opioid requirements by 20-30% when used as scheduled background analgesia.

Sourcing Paracetamol API: Key Checks

Documentation

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.

Red Flags

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.

Packaging & Logistics

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.

Market Context

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

Frequently Asked Questions

Paracetamol and acetaminophen are the same chemical compound (N-(4-hydroxyphenyl)acetamide, CAS 103-90-2). The name "paracetamol" is used in most countries worldwide (derived from para-acetylaminophenol), while "acetaminophen" is used primarily in the United States, Canada, and Japan. Both names refer to the identical API, manufactured to the same pharmacopoeia standards albeit with region-specific monograph requirements.
4-Aminophenol is the primary degradation product and synthesis impurity of paracetamol. It is both nephrotoxic and hepatotoxic. Pharmacopoeia monographs set strict limits (typically ≤ 50 ppm or 0.005%) because elevated levels indicate poor manufacturing control or degraded material. Reputable API suppliers provide HPLC data on 4-aminophenol content on every batch Certificate of Analysis. This is the single most important quality parameter to verify when sourcing paracetamol API.
Paracetamol API is supplied in multiple particle size (PSD) grades to suit different formulation needs: (1) Regular/Fine grade — standard grade for wet granulation tablet manufacturing; (2) Direct Compression (DC) grade — larger, free-flowing particles for direct compression tableting without granulation; (3) Micronized grade — sub-10-micron particles for oral suspensions and dispersible tablets. Specifying the correct PSD for your formulation process is critical — using the wrong grade can cause content uniformity failures or tableting defects.
For the EU market, the gold standard is a Certificate of Suitability (CEP) issued by the EDQM, which confirms the API meets European Pharmacopoeia monograph requirements. With a CEP, your marketing authorization application references the certificate instead of submitting full API quality data. Alternatively, an Active Substance Master File (ASMF) can be submitted. The supplier must also provide a GMP certificate issued by an EU-recognized authority, batch-specific CoA, and a declaration of compliance with ICH Q3C residual solvents and ICH M7 mutagenic impurities guidelines.
Standards: USP/CEP/EP  |  CAS: 103-90-2  |  Quality data verified against pharmacopoeia monograph COA and MSDS available  |  DrugBank  |  July 2026

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