SHELF LIFE |
Manufacturers A, B, C: 3 years |
ASSAY METHOD |
In-house HPLC method. Contents of 20 capsules mixed; measured three times; mean taken. |
ASSAY LIMITS |
90 - 125% (USP) |
SAMPLES OBTAINED |
All Manuf. |
Manuf. A |
Manuf. B |
Manuf. C |
GMS samples |
no |
% |
no |
% |
no. |
% |
no. |
% |
Total |
35 |
100 |
13 |
37 |
10 |
29 |
12 |
34 |
Harare |
19 |
54 |
|
|
|
|
|
|
Bulawayo |
16 |
46 |
|
|
|
|
|
|
Facility samples |
|
|
|
|
|
|
|
|
Total |
66 |
100 |
27 |
41 |
25 |
38 |
14 |
21 |
Age > 50% SLife |
5 |
8 |
|
|
|
|
|
|
Facility type = PCH |
50 |
76 |
|
|
|
|
|
|
Climate = hot |
55 |
83 |
|
|
|
|
|
|
Transport = slow |
46 |
70 |
|
|
|
|
|
|
Longitudinal series |
|
|
|
|
|
|
|
|
Total |
31 |
100 |
17 |
55 |
7 |
23 |
7 |
23 |
SUMMARY ASSAY RESULTS
| |
All Manuf. |
Manuf. A |
Manuf. B |
Manuf. C |
GMS samples |
no |
% |
no |
% |
no. |
% |
|
|
Mean age (mths) |
|
1.5 |
|
1.7 |
|
1.5 |
|
1.3 |
Mean assay |
|
103.0% |
|
103.4% |
100.0% |
105.0% |
95% CL |
101.2-104.8% |
101.8-105.1% |
97.1 - 102.9% |
101.0-109.0% |
No, and % fail |
0 |
0% |
0 |
0% |
0 |
0% |
0 |
0% |
Facility samples |
All Manuf. |
Manuf. A |
Manuf. B |
Manuf. C |
Mean age (mths) |
|
10.1 |
|
9.9 |
|
12.4 |
|
6.6 |
Mean assay |
|
103.5% |
|
105.8% |
101.6% |
|
102.5% |
95% CL |
102.1 - 104.9% |
103.7 - 108.0% |
99.2-103.9% |
100.0-104.9% |
No. and % fail |
0 |
0% |
0 |
0% |
0 |
0% |
0 |
0% |
Longitudinal series |
at Manuf. |
at GMS |
at facility |
|
|
Mean age (mths) |
|
0 |
|
1.6 |
|
7.2 |
|
|
Mean assay |
|
102.2% |
|
102.4% |
103.4% |
|
|
95% CL |
100.9-103.4% |
100.9-103.8% |
101.7-105.2% |
|
|
No, and % fail |
0 |
0% |
0 |
0% |
0 |
0% |
|
|
| |
Mean interval (mths) |
5.7 |
| |
Mean loss (-) or gain (+) |
+1.1% |
| |
95% CL for loss/gain |
-0.8 + +3.0% |
Figure 1 - Results of facility samples
Findings:
a) No expired samples found.
b) All 35 GMS samples were within assay limits (mean 103.0%).
c) All 66 facility samples were within assay limits (mean 103.5%), however two results were borderline (90.5, 91.0%).
d) No consistent loss of potency was seen in 31 GMS/facility sample pairs,
e) No difference in manufacturers.
f) No initial quality problem was seen.
g) No Sign of instability, however the samples were in the early part of a long shelf-life (mean age 10.1 months).
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