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)