Paracetamol (INN; also called acetaminophen), CAS 103-90-2, chemically N-(4-hydroxyphenyl)acetamide, is a widely used pharmaceutical active ingredient (API). This product is supplied in DC 90 grade – white, free-flowing fine granules designed for direct compression tabletting – to the specification below, with per-batch COA and SDS.
Specifications (DC 90 grade)
| Parameter | Specification |
|---|---|
| Appearance | White free flowing fine granules |
| Identification A (chemical reaction) | Conforms |
| Identification B (IR, vs reference standard) | Conforms |
| Assay | 87.5 – 92.5% |
| Loss on drying | 1.00 – 2.40% |
| Bulk density | 0.50 – 0.70 g/ml |
Sieve analysis
| Fraction | Specification |
|---|---|
| Retained on USS 20 | 20% max |
| Retained on USS 40 | 40% min |
| Retained on USS 60 | 65% min |
| Accumulated on USS 80 | 75% min |
| Pan | 25% max |
The particle-size distribution is what makes this a direct-compression (DC) grade: the granules flow and compact well, so they can be tabletted with minimal or no granulation step.
Related substances
| Impurity | Specification |
|---|---|
| Impurity J (4-chloroacetanilide) | 10 ppm max |
| Impurity K (4-aminophenol) | 50 ppm max |
| Impurity F (4-nitrophenol) | 0.05% max |
| Any other impurity | 0.05% max |
| Total of other impurities | 0.10% max |
Microbial limits
| Test | Specification |
|---|---|
| Total aerobic bacteria count | NMT 103 cfu/g |
| Mold and yeast count | NMT 102 cfu/g |
| Escherichia coli | None |
A full specification sheet and a certificate of analysis (COA) for each batch are available on request.
Basic Information
| CAS number | 103-90-2 |
| Synonyms | Paracetamol; acetaminophen; APAP; N-(4-hydroxyphenyl)acetamide; 4-acetamidophenol; 4-hydroxyacetanilide |
| Molecular formula | C8H9NO2 |
| Molecular weight | 151.16 g/mol |
| Grade | DC 90 (direct-compression granules) |
| Appearance | White free flowing fine granules |
Applications
- Solid dosage manufacturing – direct-compression tabletting of paracetamol tablets (the DC 90 granule form is designed for this).
- Tablet and capsule manufacture – as the active ingredient in formulated solid dose products.
- Other solid forms – where a free-flowing, compactable API granule is preferred.
- Formulation development – as an API for pharmaceutical formulation, subject to registration and GMP requirements.
This material is an active pharmaceutical ingredient (API) for pharmaceutical manufacturing. Finished medicines must be made by appropriately licensed manufacturers, and import, registration and use are governed by the regulations of the destination market.
Packaging and documentation
- 25 kg fibre drums (or as agreed), with inner liner; keep sealed, cool and dry.
- Per-batch certificate of analysis (COA) and safety data sheet (SDS); additional regulatory documents on request.
- Store sealed, cool and dry, away from moisture and strong odours.
PolyBlueChem supplies Paracetamol (acetaminophen, CAS 103-90-2) DC 90 grade to this specification, with per-batch COA and SDS and FOB/CIF delivery. Contact us with your application, tonnage, documentation requirements and delivery port for a quotation.
