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