Table 4 Results of quantity, content uniformity, and dissolution testing of metformin hydrochloride tablets

From: Quality and Authenticity of Metformin Tablets Circulating on Japanese Websites

Sample No Dose (mg) Quantitative analysis Content uniformity test Dissolution test Any fail
Mean content (%) Judgment Acceptance value Judgment Mean dissolution rate (%) Judgment Judgment
1 500 95.3 ± 2.8 Pass 9.5 Pass 99.8 ± 2.5 Pass Pass
2 500 97.5 ± 3.2 Pass 13.7 Pass 95.0 ± 1.7 Pass Pass
3 500 101.2 ± 2.4 Pass 5.9 Pass 99.2 ± 1.0 Pass Pass
4 500 99.1 ± 3.5 Pass 8.4 Pass 102.0 ± 1.9 Pass Pass
5 500 97.3 ± 1.8 Pass 5.6 Pass 96.4 ± 3.6 Pass Pass
6 500 95.5 ± 1.3 Pass 6.1 Pass 96.6 ± 1.4 Pass Pass
7 500 96.5 ± 2.3 Pass 7.6 Pass 96.1 ± 1.2 Pass Pass
8 500 97.5 ± 5.2 Pass 13.7 Pass 95.5 ± 2.4 Pass Pass
9 500 96.7 ± 4.5 Pass 12.6 Pass 104.2 ± 2.1 Pass Pass
10 500 97.3 ± 1.0 Pass 3.6 Pass 95.0 ± 2.7 Pass Pass
11 500 101.7 ± 1.5 Pass 3.6 Pass 102.2 ± 2.1 Pass Pass
12 500 96.2 ± 1.2 Pass 2.8 Pass 100.0 ± 3.6 Pass Pass
13 500 95.8 ± 2.8 Pass 9.6 Pass 99.9 ± 1.8 Pass Pass
14 500 95.6 ± 2.1 Pass 7.9 Pass 95.4 ± 2.6 Pass Pass
15 500 94.5 ± 1.5 Fail 7.7 Pass 98.4 ± 1.9 Pass Fail
16 500 103.9 ± 1.4 Pass 5.7 Pass 99.5 ± 3.1 Pass Pass
17 500 99.5 ± 3.7 Pass 8.9 Pass 100.4 ± 3.3 Pass Pass
18 500 97.1 ± 1.2 Pass 4.2 Pass 106.7 ± 11.1 Pass Pass
19 500 96.4 ± 1.9 Pass 6.7 Pass 98.7 ± 2.0 Pass Pass
20 500 99.5 ± 0.7 Pass 1.7 Pass 99.8 ± 0.9 Pass Pass
21 500 93.6 ± 5.7 Fail 18.6 Fail 102.2 ± 1.8 Pass Fail
22 500 101.7 ± 2.9 Pass 7.0 Pass 103.8 ± 2.2 Pass Pass
23 500 96.3 ± 1.5 Pass 5.7 Pass 105.5 ± 4.8 Pass Pass
24 500 98.5 ± 0.7 Pass 1.7 Pass 98.1 ± 0.9 Pass Pass
25 500 96.3 ± 3.8 Pass 11.3 Pass 102.0 ± 1.7 Pass Pass
26 500 96.5 ± 1.4 Pass 5.5 Pass 99.6 ± 4.0 Pass Pass
27 500 96.2 ± 4.2 Pass 12.4 Pass 99.5 ± 3.2 Pass Pass
28 500 95.9 ± 1.8 Pass 7.1 Pass 99.0 ± 3.3 Pass Pass
29 500 107.0 ± 2.8 Fail 12.1 Pass 101.6 ± 1.1 Pass Fail
30 500 99.1 ± 1.8 Pass 4.2 Pass 104.7 ± 1.5 Pass Pass
31 500 99.0 ± 1.9 Pass 4.6 Pass 103.4 ± 1.2 Pass Pass
32 500 97.8 ± 1.1 Pass 3.3 Pass 100.9 ± 5.0 Pass Pass
33 500 96.1 ± 1.4 Pass 5.8 Pass 100.0 ± 1.6 Pass Pass
34 500 96.5 ± 4.7 Pass 13.3 Pass 1 h: 33.7 ± 4.7
3 h: 60.0 ± 1.8
10 h: 95.6 ± 4.0
Pass Pass
35 500 104.3 ± 5.8 Pass 16.6 Fail 1 h: 32.8 ± 0.4
3 h: 60.8 ± 1.6
10 h: 99.8 ± 4.8
Pass Fail
36 1,000 116.71 ± 16.5 Fail 54.9 Fail 1 h:33.0 ± 1.6
2 h:49.3 ± 1.2
6 h: 87.0 ± 6.3
10 h: 96.7 ± 3.9
Fail Fail
37 500 109 ± 3.0 Pass 14.8 Pass 1 h: 29.1 ± 1.5
3 h: 57.0 ± 10.3
10 h: 93.2 ± 6.6
Pass Pass
38 750 100.5 ± 8.7 Pass 21.1 Fail 1 h: 30.5 ± 1.4
2 h: 46.2 ± 5.3
6 h: 83.4 ± 4.1
10 h: 94.7 ± 2.2
Pass Fail
39 500 104.3 ± 2.8 Pass 9.6 Pass 1 h: 35.8 ± 4.8
3 h:63.9 ± 5.9
10 h: 98.6 ± 2.8
Pass Pass
40 500 99.2 ± 7.5 Pass 23.0 Fail 1 h: 38.7 ± 1.4
3 h: 68.6 ± 3.3
10 h: 97.6 ± 2.2
Fail Fail