Table 1 Various dosage forms of Paracetamol and the established threshold of PCA; the calculations were based on PDE 34 µg/day.
From: A proposed limit test for p-chloroaniline impurity in paracetamol pharmaceutical formulations
Dosage form | Unit dose | Paracetamol mg/Unit dose | Co-drug class | Product daily dose (Number of units/Day) | PCA Threshold µg/unit dose | Established Threshold ppm | Sample taken | |
|---|---|---|---|---|---|---|---|---|
1 | Syrup | 5 mL | 125.00 | Antihistamine Decongestant | 3.00 | 11.33 | 2.266 | 22.07 µl |
2 | Syrup | 5 mL | 120.00 | None | 6.00 | 5.67 | 1.133 | 44.13 µl |
3 | IV Solution | 100 mL | 1000.00 | None | 4.00 | 8.50 | 0.085 | 588.24 µl |
6 | Capsule | Content: 558.71 mg | 300.00 | Muscle Relaxant | 6.00 | 5.67 | 10.148 | 4.93 mg |
8 | Tablet | 578.42 mg | 300.00 | Antihistamine Decongestant | 3.00 | 11.33 | 19.594 | 2.55 mg |
9 | Tablet | 721.34 mg | 500.00 | Stimulant | 8.00 | 4.25 | 5.892 | 8.49 mg |
10 | Sachet | 6146.66 mg | 600.00 | Decongestant | 6.00 | 5.67 | 0.922 | 54.23 mg |
