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Table 1 In-vitro quality of two reference and five generic diclofenac tablet brands available on the Saudi market

From: Pharmaceutical quality of seven brands of diclofenac tablet on the Saudi market

Code Weight, n = 20 Active substance contentb, n = 20 Breaking force, n = 10 Friabilityc, n = 20 Disintegrationd
Phosphate buffer, n = 6
Dissolutione
Phosphate buffer, n = 8
Mean (SD), mg Rangea, % from mean Mean (SD), mg Mean (SD), % of label Mean (SD), kg/cm2 % loss Range
Hour: minute: second
Mean (range)
release at 60 min, % of label
R1 317.0 (8.1) 95–104 50.5 (1.7) 100.9 (3.4) 12.2 (1.3) 0.0014 00:13:25 to 00:14:30 94 (89–99)
G1 262.4 (2.1) 99–102 54.6 (1.9) 109.2 (3.8) 9.3 (0.4) 0.0013 00:14:30 to 00:17:20 96 (84–104)
G2 264.6 (2.6) 99–102 51.1 (2.8) 102.1 (5.7) 6.4 (0.6) 0.0009 00:07:05 to 00:08:55 95 (66–103)g
G3 204.8 (1.7) 98–102 49.4 (1.3) 98.8 (2.7) 13.3 (1.0) 0.0012 00:05:10 to 00:05:50 89 (78–94)g
G4 205.6 (1.6) 99–101 50.2 (2.1) 100.4 (4.3) 11.4 (0.9) 0.0007 00:04:05 to 00:04:50 100 (93–105)
R2 302.3 (2.2) 99–102 105.6 (4.2) 105.6 (4.2) 12.9 (1.8) 0.0012 01:59:16 to 02:14:49f See Fig. 1
G5 263.9 (2.9) 98–102 100.4 (3.9) 100.4 (3.9) 8.6 (0.5) 0.0261 01:58:02 to 02:13:56f See Fig. 1
  1. aAcceptable variation limits ≤ ± 7.5% for tablets > 80 and < 250 mg and ≤ ± 5% for tablets ≥ 250 mg; to pass, no more than 2/20 tablet differ by more than the percentage permitted and no one tablet differ by more than double the percentage
  2. bAcceptable limits, mean content 90–110% of label
  3. cAcceptable limit ≤ 1%
  4. dpH 6.8
  5. eFor R1 and G1-G4, pH 6.8, acceptable limits, ≥ 75 + 5% of label. For R2 and G5, pH 7.5
  6. fNo disintegration was observed in 0.1 N HCL for 2 h
  7. gMean (range) of 12 rather than 8 units