SHELF LIFE |
Manufacturer A: 2-3 years |
ASSAY METHOD |
In-house HPLC method Contents of 20 capsules mixed; measured three times; mean taken. |
ASSAY LIMITS |
90 - 120% (USP) |
SAMPLES OBTAINED |
Manufacturer A |
GMS samples |
no. |
% |
Total |
5 |
100 |
Harare |
2 |
40 |
Bulawayo |
3 |
60 |
Facility samples |
no. |
% |
Total |
15 |
100 |
Age > 50% SLife |
9 |
60 |
Facility type = PCH |
0 |
0 |
Climate = hot |
3 |
20 |
Transport = slow |
10 |
67 |
Longitudinal series |
|
|
Total |
5 |
100 |
SUMMARY ASSAY RESULTS
GMS samples |
Manufacturer A |
Mean age (mths) |
|
8.9 |
Mean assay |
|
102.1% |
95% CL |
96.6 - 107.7% |
No, and % fail |
0 |
0% |
Facility samples |
Manufacturer A |
Mean age (mths) |
|
17.3 |
Mean assay |
|
110.1% |
95% CL |
105.0 - 115.1% |
No, and % fail |
2 |
13% |
No, and % low fail |
1 |
7% |
No, and % high fail |
1 |
7% |
Longitudinal series |
at manufacturer |
at GMS |
at facility |
Mean age (mths) |
|
0 |
6.9 |
17.1 |
Mean assay |
|
100.4% |
104.9% |
109.8% |
95% CL |
98.6 - 102.1 % |
99.6-110.2% |
106.1 - 113.5% |
No. and % fail |
0 |
0% |
0 |
0% |
0 |
0% |
| |
Mean interval (mths) |
10.1 |
| |
Mean loss (-) or gain (+) |
+5.0% |
| |
95% CL for loss/gain |
-2.0 to +11.9% |
Figure 1 - Results of facility samples
Findings:
a) Five of 20 facility samples (26%) were expired; these results were excluded.
b) All five GMS samples were within assay limits (mean 102.1 %).
c) Two of 15 facility samples (13%) failed; one failure was below the lower limit (82.7%) at age 21.9 months.
One failure was above the upper limit (125.2%).
The mean facility assay tended towards the upper limit of specifications (110.1%),
d) No consistent loss of potency was found in five GMS/facility sample pairs.
e) Small sample size/wide confidence limits make interpretation difficult,
f) No initial quality problem was seen.
g) No evidence of instability, except one failure which may be due to a measurement error,
h) Three expired samples had a lower mean assay (97.8%) at mean age 27.7 months.
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