The results of the analyses on the 29 ergometrine samples from Malawi, Gambia, Sudan and Zimbabwe are given in Annex 1 and summarized in Table 2. As can be seen from the table, 4 (14%) field samples were expired. Only 6 (21%) conformed to USP/BP standards with a level of active ingredient of 90-110% of the stated amount, 8 (28%) samples had less than 60% active ingredient. Defective products were found in all four countries.
Levels of active ingredient in the six samples of oxytocin injection taken from district hospitals in Zimbabwe are given in Annex 2, One sample was expired. Of the remaining five samples one was within USP/BP limits and four were above, with values between 104-142% of the stated amount.
Table 2 Active ingredient of ergometrine maleate injection in five countries
| |
No. |
Expired |
Level of active ingredient* |
| |
|
|
90-110% |
80-89% |
60-79% |
<60% |
Malawi, 1990 |
9 |
2 |
|
1 |
3 |
3 |
Gambia, 1990 |
4 |
2 |
1 |
|
1 |
|
Sudan, 1990 |
5 |
|
|
|
1 |
4 |
Zimbabwe, 1991 |
11 |
|
5 |
3 |
2 |
1 |
Total |
29 |
4 |
6 |
4 |
7 |
8 |
% |
100% |
14% |
21% |
14% |
24% |
28% |
* as percentage of stated content
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