Paracetamol Tablets 500mg
Category：Other Pharmaceutical
Introduction
Product Overview
Paracetamol (acetaminophen) 500mg tablets are a widely used analgesic and antipyretic medication for mild to moderate pain and fever. This specification covers composition, pharmacodynamics, quality standards, and manufacturing requirements.
Composition & Formulation
| Component | Function | Quantity per Tablet |
|---|---|---|
| Paracetamol (API) | Active ingredient | 500 mg |
| Microcrystalline Cellulose | Binder/Diluent | 50–100 mg |
| Pregelatinized Starch | Disintegrant | 20–40 mg |
| Magnesium Stearate | Lubricant | 5–10 mg |
| Purified Water* | Granulation solvent | q.s. (evaporates) |
(q.s. = quantum satis, removed during processing)
Pharmacological Profile
| Parameter | Specification | Reference Standard |
|---|---|---|
| Mechanism of Action | COX-2 inhibition (central) | WHO Monograph |
| Onset of Action | 30–60 min (oral) | Clinical studies |
| Peak Plasma Concentration | 1–2 hours post-dose | FDA Labeling |
| Half-life (t₁/₂) | 1–4 hours | EMA Assessment Report |
| Metabolism | Hepatic (glucuronidation/sulfation) | ICH Guidelines |
Quality Control Tests
| Test | Acceptance Criteria | Method |
|---|---|---|
| Assay (HPLC) | 95–105% of label claim | USP <621> |
| Dissolution (30 min) | ≥80% dissolved | USP <711> (Paddle, 50 rpm, 0.1N HCl) |
| Uniformity of Weight | ±7.5% deviation | Ph. Eur. 2.9.5 |
| Related Substances | Total impurities ≤0.1% | ICH Q3A |
| Microbial Limits | Absence of pathogens | USP <61> |
Packaging & Stability
| Parameter | Specification |
|---|---|
| Primary Packaging | PVC/PVDC blister or HDPE bottle |
| Shelf Life | 36 months (unopened) |
| Storage Conditions | Below 30°C, ≤65% RH |
| Light Sensitivity | Protect from moisture & light |
| Regulatory Compliance | USP/EP/JP monographs |
Therapeutic Use Guidelines
| Patient Group | Dosage Regimen | Maximum Daily Dose |
|---|---|---|
| Adults & adolescents (≥12 yrs) | 500–1000 mg every 4–6h | 4000 mg (4 g) |
| Children (6–12 yrs) | 250–500 mg every 4–6h | 2000 mg (2 g) |
| Hepatic Impairment | Avoid or reduce dose | 2000 mg (2 g) |
| Elderly (>65 yrs) | Monitor for side effects | 3000 mg (3 g) |
Conclusion
Paracetamol 500mg tablets provide effective, well-tolerated analgesia with standardized quality controls. Strict adherence to dosing limits prevents hepatotoxicity, while robust formulation ensures stability and bioavailability.
1. Name of the medicinal product
Paracetamol 500 mg Tablets
2. Pharmaceutical form
White capsule-shaped tablets, scored on one side.
3. Therapeutic indications
Paracetamol is a mild analgesic and antipyretic. The tablets are recommended for the treatment of most painful and febrile conditions, for example headache including migraine and tension headaches, toothache, backache, rheumatic and muscle pains, dysmenorrhoea, sore throat, and for relieving the fever, aches and pains of colds and flu.
Also recommended for the symptomatic relief of pain due to non-serious arthritis.
4. Shelf life
48 months
5. Special precautions for storage
Containers: Keep the container tightly closed. Store in the original container.
Blister packs: Store in the original package. Keep container in the outer carton.
6. Nature and contents of container
Containers
High-density polystyrene containers with polythene lids and/or polypropylene containers with polypropylene or polythene lids and polythene/polyurethane inserts.
Pack sizes: 100, can be customized
Blister pack
1. PVC/child-resistant push through foil (Paper/30pm soft Al laminated film with Al side heat sealed to PVC).
2. PVC/child-resistant composite film (15 pm PVC/20pm Al).
Pack sizes: 2, 4, 8, 12 and 16, can be customized
Factory & Shipment
