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: 1C

Country: Gabon
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%

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

 
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