Product name: Paracetamol DC (Direct‑Compressible Grade)
CAS‑No：103‑90‑2
Molecular Formula: C8H9NO2Molecular Weight: 151.16 g/mol
1. Product Brief
Paracetamol DC is direct‑compressible granular grade of Paracetamol (Acetaminophen). It is produced by fluid‑bed granulation with co‑processed pharmaceutical excipients. Compared with standard paracetamol powder, DC grade features excellent flowability and compressibility, suitable for high‑speed direct compression tableting without wet granulation process. Available in DC90, DC96 common grades, complying with USP / BP / EP pharmacopoeia requirements under GMP production.
2. Physichem Properties
Appearance: White free‑flowing granules, odourless ‑
Melting Point: 168‑172 ℃ (active ingredient) ‑
Bulk Density: 0.55‑0.70 g/ml ‑
Tap Density: 0.70‑0.85 g/ml ‑
Water Solubility: Active ingredient slightly soluble in water (25 ℃)
Flow Property: Good flow for high‑speed tableting press ‑
Stability: Stable under dry condition; sensitive to moisture, strong alkali and high humidity3. Quality Specification (DC96 Grade, Pharma Grade)
| Test Item | DC90 Specification | DC96 Specification |
|---|---|---|
| Appearance | White free‑flowing odourless granules | White free‑flowing odourless granules |
| Identification | Conforms to pharmacopoeia | Conforms to pharmacopoeia |
| Assay (Paracetamol active) | 87.5‑92.5 % (target 90.0 %) | 95.0‑97.0 % (target 96.0 %) |
| Loss on Drying | ≤ 0.50 % | ≤ 0.50 % |
| Sulphated Ash / Residue on Ignition | ≤ 0.10 % | ≤ 0.10 % |
| Free p‑Aminophenol | ≤ 0.005 % | ≤ 0.005 % |
| Related Substances | Single impurity ≤0.10 %; Total impurities ≤0.50 % | Single impurity ≤0.10 %; Total impurities ≤0.50 % |
| Heavy Metals | ≤10 ppm | ≤10 ppm |
| Bulk Density | 0.45‑0.60 g/mL | 0.55‑0.70 g/mL |
| Tap Density | 0.60‑0.75 g/mL | 0.70‑0.85 g/mL |
| Melting Range (active paracetamol) | 168‑172 ℃ | 168‑172 ℃ |
| Microbial Limits | ||
| Total Aerobic Microbial Count | ≤1000 cfu/g | ≤1000 cfu/g |
| Total Yeasts & Moulds | ≤100 cfu/g | ≤100 cfu/g |
| E. coli | Absent | Absent |
4. Application & Use
Direct compression tableting: Manufacture paracetamol plain tablets, caplets and compound analgesic tablets, skip wet granulation step, improve production efficiency.
OTC pharmaceutical preparations: Antipyretic & analgesic tablets for fever and mild‑moderate pain relief.Suitable for high‑speed tablet press production; reduce capping, sticking and dusting risks during tableting.
5. Packing
Standard packing: 25 kg fiber drum with double PE inner moisture‑proof bags
Drum sealed with hoop and lid.
Outer marking: Product name, Grade, CAS No., Batch No., Mfg date, Retest date, Net/Gross weight, Manufacturer info, Made in China.
6. Delivery and Storage
Storage
Store in cool, dry, well‑ventilated warehouse, temperature below 25 ℃. Keep drums tightly closed, strictly protect from moisture and direct light. Segregate from alkaline materials. Shelf‑life: 36 months under recommended storage.
Delivery & Transportation
Non‑dangerous goods, no UN number. Avoid rain, dampness and high temperature during transit. Do not co‑transport with strong alkali, oxidants or toxic substances. Avoid dust inhalation during loading & unloading.
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