SHELF LIFE |
Manufacturers A, C: |
2 years |
| |
Manufacturer D: |
3 years |
| |
Manufacturer B: |
4 years |
ASSAY METHOD |
HPLC method, USP 1990 |
| |
Measured three times and mean taken. |
ASSAY LIMITS |
90 - 115% (USP) |
|
SAMPLES OBTAINED |
All Manuf. |
Expired (all) |
GMS samples |
no. |
% |
no |
% |
Total |
1 |
|
|
|
Harare |
1 |
|
|
|
Bulawayo |
0 |
|
|
|
Facility samples |
|
|
|
|
Total |
10 |
100 |
14 |
100 |
Age > 50% SLife |
1 |
10 |
14 |
100 |
Facility type = PCH |
4 |
40 |
12 |
86 |
Climate = hot |
7 |
70 |
8 |
57 |
Transport = slow |
5 |
50 |
8 |
57 |
Longitudinal series |
|
|
|
|
Total |
4 |
|
|
|
SUMMARY ASSAY RESULTS
| |
All Manuf. |
|
|
|
|
GMS samples |
no. |
% |
|
|
|
|
Mean age (mths) |
|
1.7 |
|
|
|
|
Mean assay |
|
101.5% |
|
|
|
|
95% CL |
|
n/a |
|
|
|
|
No, and % fail |
0 |
0% |
|
|
|
|
No. and % low fail |
0 |
0% |
|
|
|
|
No. and % high fail |
0 |
0% |
|
|
|
|
Facility samples |
All Manuf. |
Expired (all) |
|
|
Mean age (mths) |
|
5.1 |
|
29.5 |
|
|
Mean assay |
|
102.5% |
|
102.3% |
|
|
95% CL |
96.6- 108.3% |
95.6- 109.0% |
|
|
No, and % fail |
2 |
20% |
4 |
29% |
|
|
No. and % low fail |
1 |
10% |
2 |
14% |
|
|
No. and % high fail |
1 |
10% |
2 |
14% |
|
|
Longitudinal series |
at Manuf. |
at GMS |
at facility |
Mean age (mths) |
|
0.0 |
|
1.7 |
|
3.8 |
Mean assay |
|
96.0% |
|
101.5% |
|
102.6% |
95% CL |
|
n/a |
|
n/a |
99.5 - 105.7% |
No. and % fail |
0 |
0% |
0 |
0% |
0 |
0% |
| |
Mean interval (mths) |
2.1 |
| |
Mean loss (-) or gain (+) |
+1.1% |
| |
95% CL for loss/gain |
-2.0 to +4.2% |
Figure 1 - Results of facility samples
Findings:
a) 14 of 24 facility samples (58%) were expired; these results were analyzed separately.
b) Due to a stockout at GMS during the study period, only one GMS sample and four longitudinal series samples were obtained. The GMS sample was within assay specifications.
c) Two of 10 facility samples (20%) failed: one was below the lower limit (87.0%) and one was above the upper limit (123.6%).
d) Four of 14 expired samples (29%) failed; two were below the lower limit (85.4, 85.8%) and two were above the upper limit (117.0, 134.6%).
e) The mean assay for 14 expired samples was not lower than the mean for 10 "in date" samples despite a difference in a mean age of 24 months.
f) A wide range of assay values was seen (85.4 - 134.6%).
g) No loss of potency was found in four GMS/facility sample pairs, but the sample interval was short (mean 2.1 months).
h) There is no evidence of instability.
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