Paracetamol Tablets
We are a manufacturer based in China. We specialize in providing high-quality Paracetamol Tablets for industrial clients across various sectors. Whether you need chemicals consultation or technical support, our team is here to help.
Category：Pharmaceutical Reagents Own Brand：MT /MOQ:100KG /From China/ B2B only.
Introduction
As an EU GMP approved manufacturer located in China, we are able to supply high quality drugs at affordable costs. Paracetamol tablets is one of our main products and nearly 1 billion tablets are exported to the UK and other European countries each year.
Introduction
Paracetamol tablets are a widely used over-the-counter analgesic and antipyretic medication. This pharmaceutical formulation provides effective relief from mild to moderate pain and fever while maintaining a favorable safety profile when used as directed. Below are five detailed tables summarizing the tablet composition, pharmacodynamics, quality standards, manufacturing considerations, and stability parameters.
Standard Tablet Composition
| Component | Function | Typical Concentration (%) | Specification |
|---|---|---|---|
| Paracetamol | Active ingredient | 80-90 | USP/EP grade |
| Microcrystalline cellulose | Binder/Diluent | 5-15 | NF grade |
| Pregelatinized starch | Disintegrant | 3-7 | Pharmaceutical grade |
| Magnesium stearate | Lubricant | 0.5-1.5 | NF grade |
| Povidone | Binder | 1-3 | USP grade |
Pharmacological Properties
| Parameter | Value | Test Method |
|---|---|---|
| Bioavailability | 80-90% (oral) | HPLC plasma analysis |
| Time to peak concentration | 30-60 minutes | Pharmacokinetic study |
| Protein binding | 20-30% | Equilibrium dialysis |
| Elimination half-life | 1-4 hours | Mass balance study |
| Therapeutic plasma concentration | 10-20 μg/mL | Clinical monitoring |
Quality Control Specifications
| Test Parameter | Acceptance Criteria | Test Method |
|---|---|---|
| Assay | 95-105% of label claim | HPLC |
| Dissolution | ≥80% in 30 minutes | USP Apparatus II |
| Uniformity of dosage units | AV ≤15.0 | USP <905> |
| Related substances | ≤0.1% individual impurity | HPLC |
| Microbial limits | ≤1000 CFU/g | USP <61> |
Manufacturing Process Parameters
| Process Step | Critical Parameters | Control Range |
|---|---|---|
| Mixing | Mixing time | 10-15 minutes |
| Granulation | Binder solution addition rate | 50-100 mL/min |
| Drying | Inlet air temperature | 50-60°C |
| Compression | Hardness | 50-100 N |
| Coating (if applicable) | Pan speed | 10-15 rpm |
Stability and Storage Conditions
| Condition | Storage Requirement | Shelf Life |
|---|---|---|
| Long-term | 25°C/60% RH | 36 months |
| Intermediate | 30°C/65% RH | 6 months |
| Accelerated | 40°C/75% RH | 3 months |
| Photostability | Protected from light | – |
| In-use stability | Keep container tightly closed | – |
Conclusion
Paracetamol tablets represent a well-characterized pharmaceutical dosage form with established manufacturing processes and rigorous quality standards. The formulation maintains excellent stability under proper storage conditions while delivering consistent therapeutic effects. Careful control of excipient selection and process parameters ensures product quality and performance.
,Disclaimer: The above content is for reference and communication only among industry insiders, and does not guarantee its accuracy or completeness. According to relevant laws and regulations and the regulations of this website, units or individuals who purchase related items should obtain valid qualifications and qualification conditions.
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