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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