SHELF LIFE |
Manufacturer A: 2-3 years |
ASSAY METHOD |
Spectrophotometric method, BP 1988, p. 625 Contents of 20 capsules mixed; measured three times; mean taken. |
ASSAY LIMITS |
92.5 - 110% (BP) |
SAMPLES OBTAINED |
Manufacturer A |
GMS samples |
no. |
% |
Total |
6 |
100 |
Harare |
2 |
33 |
Bulawayo |
4 |
67 |
Facility samples |
no. |
% |
Total |
25 |
100 |
Age > 50% SLife |
23 |
92 |
Facility type = PCH |
0 |
0 |
Climate = hot |
13 |
52 |
Transport = slow |
17 |
68 |
Longitudinal series |
|
|
Total |
5 |
100 |
SUMMARY ASSAY RESULTS
GMS samples |
Manufacturer A |
Mean age (mths) |
|
2.7 |
Mean assay |
|
96.2% |
95% CL |
93.8 - 98.5% |
No, and % fail |
0 |
0% |
Facility samples |
Manufacturer A |
Mean age (mths) |
|
17.1 |
Mean assay |
|
98.8% |
95% CL |
97.8 - 99.8% |
No, and % fail |
0 |
0% |
Longitudinal series |
at manufacturer |
at GMS |
at facility |
Mean age (mths) |
0 |
12.6 |
20.1 |
Mean assay |
98.1% |
96.9 |
99.2 |
95% CL |
96.9 - 99.4% |
94.6 - 99.1% |
96.7-101.7% |
No. and % fail |
0 |
0% |
0 |
0% |
0 |
0% |
| |
Mean interval (mths) |
7.6 |
| |
Mean loss (-) or gain (+) |
+2.4% |
| |
95% CL for loss/gain |
+0.1 to +4.7% |
Figure 1 - Results of facility samples
Findings:
a) Four of 29 facility samples (14%) were expired; these results were excluded,
b) All six GMS samples were within assay limits (mean 96.2%).
c) All 25 facility samples were within assay limits (mean 98.8%).
d) Hospital-only drug with slow turnover: mean facility storage time: 6.4 months (0-15 months).
e) 23 of the facility samples (92%) had expended more than half their shelf life.
f) No loss of potency was found in five GMS/facility sample pairs.
g) No initial quality problem was seen.
h) No sign of instability, even in the late part of shelf life.
i) Hour expired samples had a mean assay of 100.6% at mean age 28.0 months.
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