The Quality of Antimalarials - A Study in Selected African Countries - EDM Research Series No. 030
(2003; 67 pages) Voir le document au format PDF
Table des matières
Afficher le documentAuthors
Afficher le documentCountry Research Team Leaders
Afficher le documentLaboratory Support
Afficher le documentAcknowledgements
Afficher le documentAcronyms
Afficher le documentExecutive summary
Afficher le document1. Background
Ouvrir ce répertoire et afficher son contenu2. Methodology
Afficher le document3. Results
Ouvrir ce répertoire et afficher son contenu4. Discussion
Ouvrir ce répertoire et afficher son contenu5. Conclusions and recommendations
Afficher le documentReferences
Ouvrir ce répertoire et afficher son contenuTables
Fermer ce répertoireAnnexes
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Afficher le documentANNEX: 1C
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Afficher le documentANNEX: 2C
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Afficher le documentANNEX: 4C
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Afficher le documentOther documents in the EDM Research Series
Afficher le 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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