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: 5C

Country: Mozambique
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%

20010425-P

MO/SPT/PH002

P

Gracure pharm

25.70

2.89

25.70

-

94.70

99.08

-

96.89

-

-

96.89

20010425-S

MO/SPT/PH002

P

Gracure pharm

73.34

1.06

-

73.34

99.59

94.95

-

97.27

-

-

97.27

20010437-P

MO/SPT/TH002

TH

Duopharma, Malaysia

22.50

30.47

22.50

-

99.42

96.47

-

97.95

-

-

97.95

10010437-S

MO/SPT/TH002

TH

Duopharma, Malaysia

94.48

4.89

-

94.48

96.79

97.19

-

96.99

-

-

96.99

20010439-P

MO/SPT/CS001

CMS

Pharmanova, Malawi

14.48

33.04

14.48

-

97.32

98.84

-

98.08

-

-

98.08

20010439-S

MO/SPT/CS001

CMS

Pharmanova, Malawi

49.56

3.81

49.56

-

98.13

TLS

-

98.13

-

-

98.13

20010440-P

MO/SPT/HC002

HC

Limassol, Cyprus

45.82

21.00

45.82

-

96.75

98.01

-

97.38

-

-

97.38

20010440-S

MO/SPT/HC002

HC

Limassol, Cyprus

87.40

10.39

-

87.40

98.68

97.42

-

98.05

-

-

98.05

20010441-P

MO/SPT/HC001

HC

Alferez Pvt Ltd, India

4.97

40.52

4.97

-

96.06

93.47

-

94.76

-

-

94.76

20010441-S

MO/SPT/HC001

HC

Alferez Pvt Ltd, India

41.61

17.23

41.61

-

98.20

99.37

-

98.78

-

-

98.78

20010442-P

MO/SPT/HC003

HC

Pharmanova, Malawi

12.68

0.00

12.68

-

103.03

98.45

-

100.74

-

-

100.74

20010442-S

MO/SPT/HC003

HC

Pharmanova, Malawi

46.44

2.51

46.44

-

93.37

94.42

-

93.89

-

-

93.89

20010444-P

MO/SPT/DS001

DMS

Pharmamed, Malta

50.70

15.39

50.70

-

89.10

96.48

-

92.79

-

-

92.79

20010444-S

MO/SPT/DS001

DMS

Pharmamed, Malta

92.29

1.46

-

92.29

98.24

100.10

-

99.17

-

-

99.17

20010445-P

MO/SPT/VE/02

SV

N/A

27.98

9.55

27.98

-

104.68

103.92

-

104.30

-

-

104.30

20010445-S

MO/SPT/VE/02

SV

N/A

65.03

6.61

-

65.03

99.74

98.90

-

99.32

-

-

99.32

20010447-P

MO/SPT/TH001

TH

Nordia, Dinamarca

21.94

31.34

21.94

-

100.15

TLS

-

100.15

-

-

100.15

20010447-S

MO/SPT/TH001

TH

Nordia, Dinamarca

94.15

3.11

-

94.15

101.74

101.13

-

101.43

-

-

101.43

20010449-P

MO/SPT/VE001

SV

No information

12.68

0.00

12.68

-

80.69

78.91

-

79.80

79.80

-

-

20010449-S

MO/SPT/VE001

SV

No information

44.22

3.44

44.22

-

98.14

100.01

-

99.08

-

-

99.08

20010450

MO/SPT/VE/01

SV

No information*

-

-

-

-

-

-

-

-

-

-

-

20010453-P

MO/SPT/PH003

P

Remedica, Cyprus

53.53

12.61

53.53

-

103.33

102.75

103.61

103.23

-

-

103.23

20010453-S

MO/SPT/PH003

P

Remedica, Cyprus

75.75

6.26

-

75.75

102.66

104.16

103.20

103.34

-

-

103.20

20010454-P

MO/SPT/HH001

H

N/A

12.68

0.00

12.68

-

97.49

97.93

-

97.71

-

-

97.71

20010454-S

MO/SPT/HH001

H

N/A

47.88

1.93

47.88

-

99.18

98.13

-

98.66

-

-

98.66

20010457-P

MO/SPT/PH/05

P

Duopharma, Malaysia

15.06

18.02

15.06

-

97.49

97.93

-

97.71

-

-

97.71

20010457-S

MO/SPT/PH/05

P

Duopharma, Malaysia

93.52

4.09

-

93.52

99.18

98.13

-

98.66

-

-

98.66

20010490-P

MO/SPT/PH/03

P

Alison SPRL, Belgium

31.01

43.16

43.16

-

101.91

98.85

102.59

101.12

-

-

101.12

20010490-S

MO/SPT/PH/03

P

Alison SPRL, Belgium

56.81

50.95

50.95

-

100.82

98.95

97.19

98.99

-

-

98.99

200104150-P

MO/SPT/TH/01

TH

Duopharma, Malaysia

17.68

30.05

17.68

-

98.39

102.61

101.53

100.84

-

-

100.84

200104150-S

MO/SPT/TH/01

TH

Duopharma, Malaysia

96.15

4.66

-

96.15

100.10

102.47

100.01

100.86

-

-

100.86

200104151-P

MO/SPT/CS/04

CMS

Duopharma, Malaysia

23.11

8.54

23.11

-

TLS

105.40

107.10

106.25

-

-

105.25

200104151-S

MO/SPT/CS/04

CMS

Duopharma, Malaysia

97.18

3.90

-

97.18

98.48

99.51

100.02

99.34

-

-

99.34

200104153-P

MO/SPT/CS/03

CMS

Limassol, Cyprus

55.43

5.97

55.43

-

110.07

110.30

109.49

109.95

-

-

109.95

200104153-S

MO/SPT/CS/03

CMS

Limassol, Cyprus

97.92

1.03

-

97.92

100.36

99.93

98.10

99.46

-

-

99.46

200104155-P

MO/SPT/PH5

P

Kopran Ltd, India

4.42

18.46

4.42

-

113.08

109.10

110.06

110.75

-

110.75

-

200104155-S

MO/SPT/PH5

P

Kopran Ltd, India

9.76

20.54

9.76

-

101.62

99.25

99.41

100.09

-

-

100.09

REF NO: Reference number

RSD: Related standard deviation

CP: Collection point

 

DMS: District medical stores

P: Pharmacy

CMS: Central medical stores

 

SV: Street vendor

TH: Teaching hospital

P: Pyrimethamine

S: Sulphadoxine

HC: Health centre

H: Household

TLS: Too little sample (not enough tablets)

 

*: Probably counterfeit/incorrectly labelled

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