Country: Ghana
Product: Sulphadoxine/pyrimethamine tablets
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CENQAM LAB RESULTS |
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Dissolution test |
Active ingredient content |
CENQAM REF NO |
Sample number |
CP |
Manufacturer |
Mean dissolution |
% RSD (n=6) |
Low fail <65% |
Pass >65% |
1st value |
2nd value |
3rd value |
Mean value |
Low fail <90% |
High fail >110% |
Pass 90-110% |
20010503-P |
GH/SPT/SH118 |
S |
Uni-med, India |
0.19 |
223.61 |
0.19 |
- |
90.27 |
93.33 |
92.79 |
92.13 |
- |
- |
92.13 |
20010503-S |
GH/SPT/SH118 |
S |
Uni-med, India |
5.61 |
6.36 |
5.61 |
- |
92.19 |
94.47 |
93.32 |
93.33 |
- |
- |
93.33 |
20010504-P |
GH/SPT/PH17 |
P |
Kinapharma Accra |
16.89 |
9.89 |
16.89 |
- |
92.23 |
95.82 |
94.62 |
94.22 |
- |
- |
94.22 |
20010504-S |
GH/SPT/PH17 |
P |
Kinapharma Accra |
97.79 |
2.20 |
- |
97.79 |
98.81 |
99.18 |
98.87 |
98.95 |
- |
- |
98.95 |
20010505-P |
GH/SPT/HH72 |
H |
Unknown |
NS |
- |
- |
- |
93.48 |
99.08 |
- |
96.28 |
- |
- |
96.28 |
20010505-S |
GH/SPT/HH72 |
H |
Unknown |
NS |
- |
- |
- |
- |
- |
- |
NSX |
- |
- |
- |
20010506-P |
GH/SPT/HH70 |
H |
Dannex Ltd, Accra |
NS |
- |
- |
- |
81.80 |
83.00 |
- |
82.40 |
82.40 |
- |
- |
20010506-S |
GH/SPT/HH70 |
H |
Dannex Ltd, Accra |
NS |
- |
- |
- |
71.07 |
71.45 |
- |
71.26 |
71.26 |
- |
- |
20010507-P |
GH/SPT/DS05 |
DMS |
Farmitalia, Italy |
NS |
- |
- |
- |
- |
- |
- |
NP |
- |
- |
- |
20010507-S |
GH/SPT/DS05 |
DMS |
Farmitalia, Italy |
NS |
- |
- |
- |
- |
- |
- |
IDS |
- |
- |
- |
20010508-P |
GH/SPT/DH06 |
DH |
Farmitalia, Italy |
NS |
- |
- |
- |
- |
- |
- |
NP |
- |
- |
- |
20010508-S |
GH/SPT/DH06 |
DH |
Farmitalia, Italy |
NS |
- |
- |
- |
- |
- |
- |
IDS |
- |
- |
- |
20010509-P |
GH/SPT/PH13 |
P |
Colorama, UK |
NS |
- |
- |
- |
97.92 |
101.64 |
95.68 |
98.41 |
- |
- |
98.41 |
20010509-S |
GH/SPT/PH13 |
P |
Colorama, UK |
NS |
- |
- |
- |
97.80 |
100.20 |
95.61 |
97.87 |
- |
- |
97.87 |
20010510-P |
GH/SPT/PH112 |
P |
Dannex Ltd, Accra |
14.78 |
14.15 |
14.78 |
- |
90.41 |
89.63 |
87.97 |
89.34 |
89.34 |
- |
- |
20010510-S |
GH/SPT/PH112 |
P |
Dannex Ltd, Accra |
88.01 |
1.92 |
- |
88.01 |
94.34 |
95.27 |
94.57 |
94.72 |
- |
- |
94.72 |
20010511-P |
GH/SPT/HH40 |
H |
Unknown |
NS |
- |
- |
- |
98.92 |
92.48 |
- |
95.70 |
- |
- |
95.70 |
20010511-S |
GH/SPT/HH40 |
H |
Unknown |
NS |
- |
- |
- |
- |
- |
- |
NSX |
- |
- |
- |
20010512-P |
GH/SPT/PH114 |
P |
Colorama Pharm Ltd, India |
13.49 |
10.87 |
13.49 |
- |
90.27 |
84.93 |
83.91 |
86.37 |
86.37 |
- |
- |
20010512-S |
GH/SPT/PH114 |
P |
Colorama Pharm Ltd, India |
75.25 |
3.65 |
- |
75.25 |
93.25 |
94.40 |
96.07 |
94.57 |
- |
- |
94.57 |
20010525-P |
GH/SPT/PH019 |
P |
Ajanta Pharm, Mauritius |
68.19 |
6.07 |
- |
68.19 |
105.58 |
105.66 |
101.28 |
104.17 |
- |
- |
104.17 |
20010525-S |
GH/SPT/PH019 |
P |
Ajanta Pharm, Mauritius |
102.60 |
4.37 |
- |
102.60 |
104.73 |
106.14 |
104.74 |
105.21 |
- |
- |
105.21 |
REF NO: Reference number |
RSD: Related standard deviation |
CP: Collection point |
|
DH: District hospital |
DMS: District medical stores |
H: Household |
S: Shop |
P: Pharmacy |
P: Pyrimethamine |
S: Sulphadoxine |
NS: No sample (number of units for testing insufficient) |
IDS: Identity of the sulphadoxine questionable |
NP: No pyrimethamine detected |
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NSX: No sulphadoxine detected |
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