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%

20010526-P

GA/SPT/VE08

SV

Brintlodge
Ltd, UK

-

-

-

-

101.76

99.92

102.48

101.39

-

-

101.39

20010526-S

GA/SPT/VE08

SV

Brintlodge
Ltd, UK

-

-

-

-

95.75

95.47

94.64

95.28

-

-

95.28

20010527-P

GA/SPT/HC01

HC

Remedica,
Cyprus

-

-

-

-

100.21

106.14

110.22

105.52

-

-

105.52

20010527-S

GA/SPT/HC01

HC

Remedica,
Cyprus

-

-

-

-

97.97

99.29

101.23

99.49

-

-

99.49

20010528-P

GA/SPT/TB12

NK

Pharmamed
Ltd, Malta

-

-

-

-

97.57

101.61

90.22

96.47

-

-

96.47

20010528-S

GA/SPT/TB12

NK

Pharmamed
Ltd, Malta

-

-

-

-

106.36

102.59

99.21

102.72

-

-

102.72

20010529-P

GA/SPT/VE09

SV

Brintlodge
Ltd, UK

-

-

-

-

90.20

93.91

91.43

91.85

-

-

91.85

20010529-S

GA/SPT/VE09

SV

Brintlodge
Ltd, UK

-

-

-

-

97.17

97.61

96.09

96.96

-

-

96.96

20010530-P

GA/SPT/PH11

P

Roche lab,
France

-

-

-

-

97.46

100.27

100.40

99.38

-

-

99.38

20010530-S

GA/SPT/PH11

P

Roche lab,
France

-

-

-

-

96.08

99.94

102.47

99.50

-

-

99.50

20010531-P

GA/SPT/PH10

P

Gracure
Pharm, India

-

-

-

-

103.09

96.40

99.21

99.57

-

-

99.57

20010531-S

GA/SPT/PH10

P

Gracure
Pharm, India

-

-

-

-

98.99

95.19

98.20

97.46

-

-

97.46

20010532-P

GA/SPT/SH03

S

Roche lab,
France

-

-

-

-

98.77

101.40

99.14

99.77

-

-

99.77

20010532-S

GA/SPT/SH03

S

Roche lab,
France

-

-

-

-

78.52

80.24

101.37

86.71

86.71

-

-

20010533-P

GA/SPT/SH02

S

Gracure
Pharm, India

-

-

-

-

98.18

96.47

100.35

98.34

-

-

98.34

20010533-S

GA/SPT/SH02

S

Gracure
Pharm, India

-

-

-

-

97.16

93.54

99.27

96.66

-

-

96.66

20010534-P

GA/SPT/VE07

SV

Brintlodge
Ltd, UK

-

-

-

-

92.47

88.04

91.83

90.78

-

-

90.78

20010534-S

GA/SPT/VE07

SV

Brintlodge
Ltd, UK

-

-

-

-

90.07

94.68

95.29

93.35

-

-

93.35

20010535-P

GA/SPT/TH06

TH

Unknown

35.60

12.70

35.60

-

91.48

91.03

96.83

93.11

-

-

93.11

20010535-S

GA/SPT/TH06

TH

Unknown

72.40

7.07

-

72.40

82.42

101.53

97.38

93.78

-

-

93.78

20010536-P

GA/SPT/DH04

DH

Adjanta
Pharma

-

-

-

-

100.87

95.66

93.94

96.82

-

-

96.82

20010536-S

GA/SPT/DH04

DH

Adjanta
Pharma

-

-

-

-

100.34

101.68

101.34

101.12

-

-

101.12

20010537-P

GA/SPT/SH05

S

Roche lab,
France

-

-

-

-

100.34

101.39

100.03

100.58

-

-

100.58

20010537-S

GA/SPT/SH05

S

Roche lab,
France

-

-

-

-

101.38

99.61

100.74

100.58

-

-

100.58

REF NO: Reference number

RSD: Related standard deviation

CP: Collection point

DH: District hospital

HC: Health centre

NK: Not known

P: Pharmacy

S: Shop

SV: Street vendor

TH: Teaching hospital

P: Pyrimethamine

S: Sulphadoxine