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Table 1 In-vitro quality of two reference and seven generic paracetamol 500 mg tablet brands available on the Saudi market

From: Quality assessment of nine paracetamol 500 mg tablet brands marketed in Saudi Arabia

Code Weight n = 20 Active substance contentb n = 20 Breaking force n = 10 Friability n = 20 Disintegrationd n = 6 Dissolutione n = 8
  Mean (SD), mg Rangea, % from mean Mean (SD), mg Mean (SD), % of label Mean (SD), kg % loss Range minute: second Mean (range) release at 30 min, % of label
R1 599.6 (4.1) 99–101 480.4 (14.6) 96.1 (2.9) 15.4 (0.7) 0.017 04:21–04:58 97 (96–98)
G1 569.4 (4.3) 98–102 497.8 (12.3) 99.6 (2.5) 16.3 (1.5) 0.625 02:35–03:09 91 (88–93)
G2 560.6 (4.3) 99–101 489.9 (12.8) 98.0 (2.6) 18.8 (1.2) 0.809 04:23–04:56 95 (92–97)
G3 553.2 (3.3) 99–101 485.9 (4.9) 97.2 (1.0) 13.1 (0.9) 0.378 04:42–05:35 97 (94–100)
R2 688.4 (5.8) 99–101 498.9 (5.7) 99.8 (1.1) 14.9 (0.9) 0.366 05:16–07:51 95 (94–97)
G4 744.1 (5.7) 99–101 488.6 (6.0) 97.7 (1.2) 9.9 (0.4) 0.717 10.39–10.59 87 (80–96)f
G5 560.6 (4.3) 99–101 497.5 (4.2) 99.5 (0.8) 18.3 (1.7) 0.351 8:43–9:30 96 (91–99)
G6 797.3 (4.5) 99–101 498.0 (5.4) 99.6 (1.1) 15.3 (1.5) 0.526 9:02–10:13 96 (94–98)
G7 838.1 (10.5) 97–102 498.1 (4.6) 99.6 (0.9) 21.0 (0.9) 0.167 12:49–13:10 96 (82–100)f
  1. aAcceptable variation limits, ≤  ± 5% (for tablets ≥ 250 mg). bAcceptable limits, mean content 90–110% of label. cAcceptable limit, ≤ 1%. dWater medium, acceptable limit, ≤ 15 min. ePhosphate buffer (pH 5.8) medium, acceptable limit, ≥ 80 + 5% of label. fMean (range) of 12 rather than 8 units