Paracetamol CAS 103-90-2

Paracetamol (CAS 103-90-2), also called acetaminophen, is a white crystalline active pharmaceutical ingredient for fever and mild to moderate pain. We supply standard crystalline powder and direct compression granules made to BP, EP and USP, with fine and micronized sizes for liquid and high-dose products. The key impurity p-aminophenol is held below 0.005% on every batch COA. It goes into tablets, capsules, suspensions, cold remedies and veterinary products. Tell us the pharmacopoeia and dosage form, and we will match the grade and particle size.

  • CAS: 103-90-2
  • EC Number: 203-157-5
  • Synonyms: Acetaminophen; APAP; 4-Acetamidophenol
  • Molecular Formula: C₈H₉NO₂
  • Appearance: White crystalline powder / DC granules
  • Standards: BP, EP, USP (ChP on request)
  • Assay (HPLC, dry basis): ≥ 99.0%
  • Melting Point: 168 to 172 °C
  • p-Aminophenol: ≤ 0.005%
  • Particle Sizes: Standard, fine and micronized powder; DC granules
  • Packaging: 1 kg vacuum foil bag; 25 kg fiber drum, custom packing available
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What Paracetamol Is

Paracetamol, sold as acetaminophen in North America, is one of the most common antipyretic and analgesic active ingredients, supplied as a white, odorless crystalline powder. The powder is manufactured to BP, EP and USP, with p-aminophenol and residual solvents treated as the critical quality points. Standard crystalline powder covers wet granulation, capsules and oral liquids, while direct compression granules run straight onto tablet presses, and fine or micronized sizes suit suspensions and high-dose tablets. Veterinary and intermediate grades are available as well.

Paracetamol in Finished Products

  • Human medicines. The active in tablets, capsules, granules and oral suspensions for fever and pain, and a common component of compound cold remedies, headache products and pediatric antipyretic lines.
  • Veterinary use. Processed into soluble powders, premixes and injections for livestock and poultry to ease fever and pain around infection or stress and support a return to normal feed intake.
  • Synthesis and research. Used as an intermediate for pharmaceutical derivatives and as a reference compound in laboratory work.

Pharmacopoeia Specifications

The table shows a standard BP/EP/USP batch as a reference; other pharmacopoeias, particle distributions and DC grades are available on request.

Test Item Standard Limit
Assay (HPLC, dry basis) ≥ 99.0%
Melting Point 168 to 172 °C
Loss on Drying ≤ 0.5%
Residue on Ignition ≤ 0.1%
p-Aminophenol (key impurity) ≤ 0.005%
Heavy Metals (as Pb) ≤ 10 ppm
Arsenic (As) ≤ 2 ppm

Packaging, Documents and Ordering

  • Trial and registration quantities ship in 1 kg vacuum foil bags and commercial lots in 25 kg fiber drums with PE liner; keep the material sealed, light-protected, cool and dry at 15 to 25 °C and away from oxidizers.
  • Each batch carries a COA, TDS and SDS, with material made to BP, EP and USP; registration support documents for a target market can be discussed at inquiry rather than assumed.
  • Non-hazardous for ocean and air freight, with custom particle sizes, DC grades and packs and 1 kg samples available. In tablet work it is commonly granulated with binders such as Povidone (PVP) CAS 9003-39-8; for a quote send pharmacopoeia, dosage form, size, quantity and destination port.

FAQ

Q: What p-aminophenol level do you control in paracetamol?

A: It is held below 0.005% to meet BP, EP and USP, and tighter limits can be arranged for pediatric or special lines.

Q: Which paracetamol grade fits direct tablet compression?

A: DC granules are for direct compression; standard crystalline powder suits wet granulation, capsules and oral liquids.

Q: Can paracetamol powder that turns slightly yellow still be used?

A: Slight yellowing is mild oxidation from air and light; use it if assay and p-aminophenol still pass, reject dark lots.

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