|
Sampling Site
|
Year
|
Test
|
Test (n/%)
|
|---|
|
Originator Brand
|
Generic
|
Total samples, n
|
|---|
|
Compliant
|
Non-compliant
|
Compliant
|
Non-compliant
|
|---|
|
China (Shanghai)
|
2012
|
Potency
|
9/100
|
0/0
|
34/97
|
1/3
|
44
|
|
Content Uniformity
|
9/100
|
0/0
|
35/100
|
0/0
|
|
Dissolution
|
9/100
|
0/0
|
35/100
|
0/0
|
|
Personal import samples
|
2013
|
Potency
|
19/100
|
0/0
|
13/100a
|
13/100a
|
59
|
|
Content Uniformity
|
19/100
|
0/0
|
13/100a
|
13/100a
|
|
Dissolution
|
19/100
|
0/0
|
8/62a
|
5/38a
|
|
Yangon, Myanmar
|
2015
|
Potency
|
1/100
|
0/0
|
59/98
|
1/2
|
60
|
|
Content Uniformity
|
1/100
|
0/0
|
59/98
|
1/2
|
|
Dissolution
|
1/100
|
0/0
|
51/86
|
8/14
|
|
Total number of samples, n
|
163
|
- aAmong the n = 31 generic samples, only 13 samples could be fully tested, as the number of tablets was insufficient
