SHELF LIFE |
Manufacturer A:4 years |
ASSAY METHOD |
Spectrophotometric method, BP 1988 p. 985. Contents of 20 capsules mixed; measured three times; mean taken. |
ASSAY LIMITS |
92.5 - 107.5% (BP) |
SAMPLES OBTAINED |
Manufacturer A |
GMS samples |
no. |
% |
Total |
14 |
100 |
Harare |
2 |
14 |
Bulawayo |
12 |
86 |
Facility samples |
|
|
Total |
59 |
100 |
Age > 50 % SLife |
4 |
7 |
Facility type = PCH |
44 |
75 |
Climate = hot |
50 |
85 |
Transport = slow |
41 |
89 |
Longitudinal Series |
|
|
Total |
7 |
100 |
SUMMARY ASSAY RESULTS
GMS samples |
Manufacturer A |
Mean age (mths) |
|
7.3 |
Mean assay |
|
99.3% |
95% CL |
96.9-101.7% |
No. and % fail |
0 |
0% |
Facility samples |
Manufacturer A |
Mean age (mths) |
|
12.5 |
Mean assay |
|
104.0% |
95% CL |
103.0 - 104.9% |
No. and % fail |
8 |
14% |
No. and % low fail |
0 |
0% |
No, and % high fail |
8 |
14% |
Longitudinal series |
at Manuf . |
at GMS |
at facility |
Mean age (mths) |
|
0 |
|
8.3 |
|
16.5 |
Mean assay |
|
100.2% |
|
99.2% |
|
103.7% |
95% CL |
99.7-100.7% |
96.1- 102.2% |
101.9- 105.6% |
No, and % fail |
0 |
0% |
0 |
0% |
0 |
0% |
| |
Mean interval (mths) |
8.2 |
| |
Mean loss (-) or gain (+) |
+4.8% |
| |
95% CL for loss/gain |
+.06 to +9.0% |
Figure 1 - Results of facility samples
Findings:
a) No expired samples found.
b) All 14 GMS samples were within assay limits (mean 99.3%).
c) Eight of 59 facility samples (14%) failed, all above the upper limit (maximum value 113.9%).
d) No loss of potency was found in seven GMS/facility sample pairs.
e) No initial quality problem was seen.
f) The high values in facility sample potency are not therapeutically significant.
g) No sign of instability, however samples were in the early part of a long shelf-life (mean age 12.5 months, maximum age 33.3 months),
h) Turnover usually fast at facility level (mean storage time 5.4 months, maximum 21.1 months).
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