SHELF LIFE |
Manufacturers A, B, C: 3 years |
| |
Manufacturer D: 2 years |
ASSAY METHOD |
Titration method, BP 1988, p.901 |
| |
Contents of 20 capsules mixed; measured three times; mean taken. |
ASSAY LIMITS |
95 - 105% (BP) |
|
|
|
|
|
SAMPLES OBTAINED |
All Manuf. |
Manuf. C |
Manuf. D |
Manuf. A+B |
| |
|
|
|
|
|
|
|
|
GMS samples |
no. |
% |
no. |
% |
no. |
% |
no. |
% |
Total |
16 |
100 |
16 |
100 |
0 |
0 |
0 |
0 |
Harare |
8 |
50 |
|
|
|
|
|
|
Bulawayo |
8 |
50 |
|
|
|
|
|
|
Facility samples |
|
|
|
|
|
|
|
Total |
79 |
100 |
59 |
75 |
17 |
22 |
3 |
3 |
Age > 50% SLife |
44 |
56 |
|
|
|
|
|
|
Facility type = PCH |
56 |
71 |
|
|
|
|
|
|
Climate = hot |
65 |
82 |
|
|
|
|
|
|
Transport - slow |
54 |
68 |
|
|
|
|
|
|
Longitudinal series |
|
|
|
|
|
|
|
|
Total |
39 |
100 |
39 |
100 |
0 |
0 |
0 |
0 |
SUMMARY ASSAY RESULTS
| |
All Manuf. |
Manuf. C |
Manuf. D |
GMS samples |
no. |
% |
no. |
% |
no. |
% |
Mean age (mths) |
|
13.2 |
|
13.2 |
|
|
Mean assay |
|
101.1% |
|
101.1% |
|
|
95% CL |
100.2 - 102.0% |
100.2 - 102.0% |
|
|
No. and % fail |
0 |
0% |
0 |
0% |
|
|
Facility samples |
All Manuf. |
Manuf, C |
Manuf. D |
Mean age (mths) |
|
17.5 |
|
19.0 |
|
11.6 |
Mean assay |
|
100.9% |
|
101.0% |
100.7% |
95% CL |
100.4 - 101.4% |
100.4 - 101.6% |
99.9-101.5% |
No. and % fail |
0 |
0% |
0 |
0% |
0 |
0% |
Longitudinal series |
at Manuf. |
at GMS |
at facility |
Mean age (mths) |
|
0 |
11.9 |
|
18.8 |
Mean assay |
|
100.3% |
100.8% |
101.1% |
95% CL |
100.1 - 100.6% |
100.2 - 101.3% |
100.4 - 101.8% |
No. and % fail |
0 |
0% |
0 |
0% |
0 |
0% |
| |
Mean interval (mths) |
6.9 |
| |
Mean loss (-) or gain (+) |
+0.4% |
| |
95% CL for loss/gain |
-0.5 + +1.2 |
Figure 1 - Results of facility samples
Findings:
a) No expired samples were found.
b) Only three samples in total for Manufacturers A and B, all within specifications.
c) All 16 GMS samples for Manufacturers C were within assay limits (mean 101.1%) at mean age 13.2 months.
d) All 79 facility samples were within assay limits (mean 100.9%) at mean age 17.5 months,
e) No consistent loss of potency was found in 39 GMS/facility sample pairs after mean interval 6.9 months.
f) No difference between manufacturers in the facility sample group. g) No initial quality problem was seen.
h) No sign of instability, even in the late part of shelf life.
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