The Quality of Antimalarials - A Study in Selected African Countries - EDM Research Series No. 030
(2003; 67 pages) View the PDF document
Table of Contents
View the documentAuthors
View the documentCountry Research Team Leaders
View the documentLaboratory Support
View the documentAcknowledgements
View the documentAcronyms
View the documentExecutive summary
View the document1. Background
Open this folder and view contents2. Methodology
View the document3. Results
Open this folder and view contents4. Discussion
Open this folder and view contents5. Conclusions and recommendations
View the documentReferences
Open this folder and view contentsTables
Close this folderAnnexes
View the documentANNEX: 1A
View the documentANNEX: 1B
View the documentANNEX: 1C
View the documentANNEX: 2A
View the documentANNEX: 2B
View the documentANNEX: 2C
View the documentANNEX: 3A
View the documentANNEX: 3B
View the documentANNEX: 3C
View the documentANNEX: 4A
View the documentANNEX: 4B
View the documentANNEX: 4C
View the documentANNEX: 5A
View the documentANNEX: 5B
View the documentANNEX: 5C
View the documentANNEX: 6A
View the documentANNEX: 6B
View the documentANNEX: 6C
View the documentANNEX: 7A
View the documentANNEX: 7B
View the documentANNEX: 7C
View the documentOther documents in the EDM Research Series
View the documentEDM Research Series No. 30
 

ANNEX: 7C

Country: Zimbabwe
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%

20010460-P

ZI/SPL/PH19

P

Roche

SYRUP

-

-

-

TLS

-

-

-

-

-

-

20010460-S

ZI/SPL/PH19

P

Roche

SYRUP

-

-

-

TLS

-

-

-

-

-

-

20010465-P

ZI/SPT/PH10

P

Pharm

5.97

14.91

5.97

-

93.58

90.27

-

91.92

-

-

91.92

20010465-S

ZI/SPT/PH10

P

Pharm

57.47

5.29

57.47

-

95.26

95.04

-

95.15

-

-

95.15

20010468-P

ZI/SPT/HC18

HC

Pharm

5.85

16.93

5.85

-

93.08

-

-

93.08

-

-

93.08

20010468-S

ZI/SPT/HC18

HC

Pharm

55.87

4.53

55.87

-

98.72

-

-

98.72

-

-

98.72

20010469-P

ZI/SPT/TH7

TH

Pharm

9.58

25.58

9.58

-

101.32

-

-

101.32

-

-

101.32

20010469-S

ZI/SPT/TH7

TH

Pharm

61.89

23.26

61.89

-

98.36

-

-

98.36

-

-

98.36

20010470-P

ZI/SPT/DH16

DH

Pharm

15.39

27.88

15.39

-

107.83

107.48

-

107.65

-

-

107.65

20010470-S

ZI/SPT/DH16

DH

Pharm

66.65

8.76

-

66.65

101.00

102.31

-

101.66

-

-

101.66

20010472-P

ZI/SPT/TH6

TH

Pharm

3.41

47.29

3.41

-

72.03

76.02

71.75

73.26

73.26

-

-

20010472-S

ZI/SPT/TH6

TH

Pharm

66.34

17.95

-

66.34

97.75

98.59

98.33

98.22

-

-

98.22

20010473-P

ZI/SPT/HC14

HC

Pharm

26.58

92.18

26.58

-

105.39

105.25

88.43

99.69

-

-

99.69

20010473-S

ZI/SPT/HC14

HC

Pharm

71.30

12.92

-

71.30

100.90

98.93

105.31

101.71

-

-

101.71

20010475-P

ZI/SPT/PH11

P

Roche

47.64

41.20

47.64

-

101.54

110.09

101.05

104.23

-

-

104.23

20010475-S

ZI/SPT/PH11

P

Roche

82.40

37.54

-

82.40

102.97

111.04

102.31

105.44

-

-

105.44

20010477-P

ZI/SPT/HC8

HC

Pharm

14.16

117.08

14.16

-

89.27

104.98

88.84

94.36

-

-

94.36

20010477-S

ZI/SPT/HC8

HC

Pharm

64.44

15.72

64.44

-

103.41

89.45

97.84

96.90

-

-

96.90

20010481-P

ZI/SPT/HC20

HC

Pharm

6.61

71.50

6.61

-

102.96

98.41

91.31

97.56

-

-

97.56

20010481-S

ZI/SPT/HC20

HC

Pharm

56.03

8.61

56.03

-

100.60

99.62

101.29

100.50

-

 

100.50

20010485-P

ZI/SPT/DH1

DH

Pharm

6.55

31.88

6.55

-

90.11

102.16

96.82

96.36

-

-

96.36

20010485-S

ZI/SPT/DH1

DH

Pharm

56.58

17.34

56.58

-

102.39

97.41

97.45

99.08

-

-

99.08

20010489-P

ZI/SPT/HC12

HC

Pharm

7.51

6.42

7.51

-

100.49

98.51

101.93

100.31

-

-

100.31

20010489-S

ZI/SPT/HC12

HC

Pharm

45.41

5.91

45.41

-

98.72

97.28

100.23

98.74

-

-

98.74

REF NO: Reference number

RSD: Related standard deviation

CP: Collection point

 

DH: District hospital

HC: Health centre

P: Pharmacy

TH: Teaching hospital

P: Pyrimethamine

S: Sulphadoxine

   

TLS: Too little sample

Pharm: Pharmanova

   

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