Analgesic, antipyretic, anti‑inflammatory, and antiplatelet API (COX‑1/COX‑2 inhibitor) for oral solid dosage forms.
Acetylsalicylic Acid (Aspirin) USP/EP is an active pharmaceutical ingredient (API) widely used for analgesic (pain relief), antipyretic (fever reduction), anti‑inflammatory, and antiplatelet indications.
⚠️ This product is for pharmaceutical compounding and manufacturing only. Not for direct consumer use.
Mechanism: Aspirin irreversibly acetylates cyclooxygenase (COX‑1/COX‑2), reducing prostaglandin and thromboxane synthesis. At analgesic/antipyretic doses it decreases peripheral and central prostaglandin‑mediated mediators of pain and fever; at low doses it inhibits platelet thromboxane A2 synthesis, providing antiplatelet activity.
Pharmaceutical Grade: USP/EP
CAS Number: 50-78-2
Molecular Formula: C9H8O4
Molecular Weight: 180.16 g/mol
Typical Pharmacopeial Specifications:
Appearance: White to off‑white crystalline powder
Identification: Conforms to USP/EP
Assay (dried basis): 99.0–101.0%
Loss on Drying: ≤0.5%
Residue on Ignition: ≤0.1%
Related Substances (e.g., salicylic acid): ≤0.3%
Heavy Metals: ≤10 ppm
Pharmaceutical Applications:
- API for oral analgesic/antipyretic/anti‑inflammatory tablets and capsules
- Low‑dose antiplatelet therapy (e.g., cardioprotection) with enteric‑coated forms
- Fixed‑dose combinations with other analgesics where appropriate
Typical Strengths / Dosage Forms:
- Immediate‑release tablets/capsules: 81–500 mg per unit
- Enteric‑coated tablets for antiplatelet use: commonly 75–100 mg per unit
- Effervescent or chewable forms as applicable
GMP & Regulatory:
- Manufactured in GMP‑certified facilities
- DMF/CEP availability on request, with standard regulatory support documentation
Stability & Storage:
Shelf life up to 36 months when stored in a tightly closed container, protected from moisture; avoid excessive heat. Hydrolysis to salicylic acid accelerates with humidity/alkaline conditions.
Packaging: Commonly 1 kg bottle, 5 kg bag, 25 kg fiber drum
Regulatory Note: For use by licensed pharmaceutical manufacturers and compounding pharmacies only. Ensure compliance with applicable regulations and labeling in the destination market.
