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Paracetamol Semi Fine Powder is a high-quality, partially micronized form of Paracetamol (acetaminophen) widely used as an analgesic and antipyretic for the relief of mild to moderate pain and fever. The semi-fine powder form offers improved solubility, better compressibility, and faster dissolution, making it ideal for tablet, capsule, and suspension formulations.
Bluepill Express manufactures pharma-grade Paracetamol Semi Fine Powder under WHO-GMP, ISO 9001:2015, and cGMP-certified facilities, ensuring consistent quality, purity, and stability compliant with IP, BP, USP, and EP standards. This API is suitable for domestic and global pharmaceutical markets.
Therapeutic Uses
- Analgesic: Relief of headache, toothache, muscle pain, and joint pain
- Antipyretic: Reduction of fever due to infections or other conditions
- Combination formulations: Used with other APIs in cold & flu remedies
- Pediatric and adult formulations: Suitable for syrups, tablets, and granules
- OTC and prescription medications
Mechanism of Action
Paracetamol exerts its analgesic and antipyretic effects by inhibiting prostaglandin synthesis in the CNS and acting on the hypothalamic heat-regulating center, which:
- Reduces pain perception in the central nervous system
- Lowers body temperature during fever
- Has minimal anti-inflammatory activity compared to NSAIDs
- Exhibits a favorable safety profile when used within therapeutic doses
Pharmacological Information
- Chemical Name: N-(4-hydroxyphenyl)acetamide
- Molecular Formula: C8H9NO2
- Molecular Weight: 151.16 g/mol
- CAS Number: 103-90-2
- Therapeutic Class: Analgesic / Antipyretic
- Pharmacological Class: Non-opioid analgesic / NSAID alternative
- ATC Code: N02BE01
Physical & Chemical Properties
| Property | Description |
|---|---|
| Appearance | White to off-white semi-fine crystalline powder |
| Solubility | Slightly soluble in water; soluble in hot water, ethanol, and methanol |
| Melting Point | 168°C – 172°C |
| pH (1% aqueous solution) | 5.0 – 6.5 |
| Storage | Store below 25°C in a dry, ventilated area, protected from light and moisture |
Technical Specifications
| Parameter | Specification |
|---|---|
| Appearance | White to off-white semi-fine crystalline powder |
| Identification | IR, UV, and HPLC positive |
| Assay (Purity) | ≥ 99.0% (HPLC) |
| Loss on Drying | ≤ 0.5% |
| Residue on Ignition | ≤ 0.1% |
| Heavy Metals | ≤ 10 ppm |
| Particle Size | 50 – 150 microns |
| Bulk Density | 0.40 – 0.55 g/mL |
| Tapped Density | 0.55 – 0.70 g/mL |
Applications
Paracetamol Semi Fine Powder API is used in:
- Tablets, capsules, granules, and oral suspensions
- Pediatric syrups and chewable formulations
- Combination cold & flu medications
- OTC and prescription pharmaceutical products
- Bulk API for domestic and international export
Documentation Provided
- Certificate of Analysis (COA)
- Material Safety Data Sheet (MSDS)
- Technical Data Sheet (TDS)
- Method of Analysis (MOA)
- Stability Data (ICH-compliant)
- Regulatory Dossier / DMF (on request)
Packaging & Export Details
- Available Packs: 5 kg | 10 kg | 25 kg HDPE drums with double poly liners
- Labeling: Product name, batch number, manufacturing/expiry dates, storage instructions
- Shelf Life: 36 months under recommended storage conditions
- Export Markets: Africa, Asia, Latin America, Europe, Middle East
