Country: Sudan
Product: Sulphadoxine/pyrimethamine tablets
| |
CENQAM LAB RESULTS |
| |
|
|
|
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% |
20020543-P |
SU/SPT/TH01 |
TH |
Lyka |
43.91 |
2.07 |
43.91 |
- |
95.38 |
96.74 |
97.10 |
96.41 |
- |
- |
96.41 |
20020543-S |
SU/SPT/TH01 |
TH |
Lyka |
87.59 |
1.47 |
- |
87.59 |
98.18 |
97.31 |
98.50 |
98.00 |
- |
- |
98.00 |
20020544-P |
SU/SPT/DH02 |
D |
General Medicine |
18.79 |
10.06 |
18.79 |
- |
- |
94.55 |
98.49 |
96.52 |
- |
- |
96.52 |
20020544-S |
SU/SPT/DH02 |
D |
General Medicine |
93.54 |
2.81 |
- |
93.54 |
- |
98.22 |
96.81 |
97.52 |
- |
- |
97.52 |
20020545-P |
SU/SPT/DS03 |
DMS |
IPCA |
73.86 |
1.12 |
- |
73.86 |
95.74 |
96.47 |
96.86 |
96.36 |
- |
- |
96.36 |
20020545-S |
SU/SPT/DS03 |
DMS |
IPCA |
92.94 |
1.71 |
- |
92.94 |
93.60 |
97.48 |
95.02 |
95.37 |
- |
- |
95.37 |
20020546-P |
SU/SPT/CS04 |
CMS |
General Medicine |
12.74 |
14.49 |
12.74 |
- |
91.04 |
97.48 |
93.85 |
94.12 |
- |
- |
94.12 |
20020546-S |
SU/SPT/CS04 |
CMS |
General Medicine |
95.32 |
1.83 |
- |
95.32 |
96.94 |
99.63 |
97.64 |
98.07 |
- |
- |
98.07 |
20020547-P |
SU/SPT/HC05 |
HC |
IPCA |
52.46 |
6.77 |
52.46 |
- |
98.79 |
98.60 |
99.25 |
98.88 |
- |
- |
98.88 |
20020547-S |
SU/SPT/HC05 |
HC |
IPCA |
87.68 |
1.70 |
- |
87.68 |
97.12 |
97.17 |
97.89 |
97.39 |
- |
- |
97.39 |
20020548-P |
SU/SPT/PH06 |
P |
Roche |
46.47 |
3.46 |
46.47 |
- |
103.22 |
108.64 |
103.36 |
105.07 |
- |
- |
105.07 |
20020548-S |
SU/SPT/PH06 |
P |
Efroze |
95.10 |
0.49 |
- |
95.10 |
100.44 |
103.48 |
97.10 |
100.34 |
- |
- |
100.34 |
20020549-P |
SU/SPT/PH07 |
P |
Efroze |
9.74 |
19.31 |
9.74 |
- |
107.44 |
104.84 |
103.59 |
105.29 |
- |
- |
105.29 |
20020549-S |
SU/SPT/PH07 |
P |
Efroze |
83.17 |
5.76 |
- |
83.17 |
97.03 |
91.94 |
94.17 |
94.38 |
- |
- |
94.38 |
20020550-P |
SU/SPT/PH08 |
P |
Elie |
50.88 |
4.11 |
50.88 |
- |
95.66 |
97.25 |
97.72 |
96.88 |
- |
- |
96.88 |
20020550-S |
SU/SPT/PH08 |
P |
Elie |
95.69 |
1.88 |
- |
95.69 |
95.47 |
96.87 |
96.73 |
96.36 |
- |
- |
96.36 |
20020551-P |
SU/SPT/SH09 |
S |
Amipharma |
14.90 |
1.77 |
14.90 |
- |
99.03 |
98.59 |
98.30 |
98.64 |
- |
- |
98.64 |
20020551-S |
SU/SPT/SH09 |
S |
Amipharma |
95.18 |
0.88 |
- |
95.18 |
100.33 |
100.27 |
99.85 |
100.15 |
- |
- |
100.15 |
20020552-P |
SU/SPT/SH10 |
S |
General Medicine |
19.10 |
7.31 |
19.10 |
- |
105.21 |
98.73 |
104.05 |
102.66 |
- |
- |
102.66 |
20020552-S |
SU/SPT/SH10 |
S |
General Medicine |
99.21 |
4.44 |
- |
99.21 |
101.56 |
95.73 |
100.61 |
99.30 |
- |
- |
99.30 |
20020553-P |
SU/SPT/SH11 |
S |
Amipharma |
15.45 |
13.81 |
15.45 |
- |
99.57 |
95.99 |
96.83 |
97.46 |
- |
- |
97.46 |
20020553-S |
SU/SPT/SH11 |
S |
Amipharma |
103.75 |
3.52 |
- |
103.75 |
101.39 |
97.90 |
99.36 |
99.55 |
- |
- |
99.55 |
20020554-P |
SU/SPT/VE12 |
V |
IPCA |
58.92 |
2.92 |
58.92 |
- |
96.42 |
97.37 |
102.11 |
98.63 |
- |
- |
98.63 |
20020554-S |
SU/SPT/VE12 |
V |
IPCA |
83.30 |
4.53 |
- |
83.30 |
96.74 |
95.62 |
- |
96.18 |
- |
- |
96.18 |
20020555-P |
SU/SPT/VE13 |
V |
Not known |
66.26 |
8.04 |
- |
66.26 |
102.65 |
103.37 |
107.35 |
104.46 |
- |
- |
104.46 |
20020555-S |
SU/SPT/VE13 |
V |
Not known |
92.89 |
11.06 |
- |
92.89 |
101.83 |
102.71 |
103.07 |
102.54 |
- |
- |
102.54 |
20020556-P |
SU/SPT/VE14 |
V |
IPCA |
72.08 |
1.03 |
- |
72.08 |
99.08 |
100.48 |
101.00 |
100.19 |
- |
- |
100.19 |
20020556-S |
SU/SPT/VE14 |
V |
IPCA |
97.40 |
1.31 |
- |
97.40 |
100.56 |
101.44 |
101.91 |
101.30 |
- |
- |
101.30 |
20020557-P |
SU/SPT/VE15 |
V |
Amipharma |
15.76 |
10.81 |
15.76 |
- |
101.58 |
102.22 |
106.94 |
103.58 |
- |
- |
103.58 |
20020557-S |
SU/SPT/VE15 |
V |
Amipharma |
99.77 |
0.79 |
- |
99.77 |
102.74 |
102.11 |
105.59 |
103.48 |
- |
- |
103.48 |
20020558-P |
SU/SPT/HH16 |
H |
Not known |
NS |
- |
- |
- |
99.16 |
- |
- |
- |
- |
- |
99.16 |
20020558-S |
SU/SPT/HH16 |
H |
Not known |
NS |
- |
- |
- |
100.86 |
- |
- |
- |
- |
- |
100.86 |
20020559-P |
SU/SPT/HH17 |
H |
Not known |
NS |
- |
- |
- |
99.24 |
- |
- |
- |
- |
- |
99.24 |
20020559-S |
SU/SPT/HH17 |
H |
Not known |
NS |
- |
- |
- |
103.21 |
- |
- |
- |
- |
- |
103.21 |
20020560-P |
SU/SPT/HH18 |
H |
Not known |
NS |
- |
- |
- |
100.90 |
99.85 |
- |
100.37 |
- |
- |
100.37 |
20020560-S |
SU/SPT/HH18 |
H |
Not known |
NS |
- |
- |
- |
101.96 |
101.21 |
- |
101.59 |
- |
- |
101.59 |
20020561-P |
SU/SPT/HH19 |
H |
Not known |
NS |
- |
- |
- |
101.44 |
100.96 |
- |
101.20 |
- |
- |
101.20 |
20020561-S |
SU/SPT/HH19 |
H |
Not known |
NS |
- |
- |
- |
102.28 |
101.65 |
- |
101.96 |
- |
- |
101.96 |
20020562-P |
SU/SPT/HH20 |
H |
Not known |
NS |
- |
- |
- |
104.05 |
102.12 |
- |
103.08 |
- |
- |
103.08 |
20020562-S |
SU/SPT/HH20 |
H |
Not known |
NS |
- |
- |
- |
104.09 |
102.30 |
- |
103.19 |
- |
- |
103.19 |
REF NO: Reference number |
RSD: Related standard deviation |
CP: Collection point |
|
|
CMS: Central medical stores |
DH: District hospital |
DMS: District medical stores |
|
|
H: Household |
HC: Health centre |
P: Pharmacy |
S: Shop |
V: Vendor |
TH: Teaching hospital |
P: Pyrimethamine |
S: Sulphadoxine |
NS: Not enough tablets received to perform dissolution test |
|