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: 3C

Country: Kenya
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%

20010603-P

KE/SPT/PH02

P

Pharmaceutical
Mfg Ltd, Kenya

18.86

22.90

18.86

-

95.86

93.41

93.39

94.22

-

-

94.22

20010603-S

KE/SPT/PH02

P

Pharmaceutical
Mfg Ltd, Kenya

75.83

11.50

-

75.83

97.44

96.27

96.76

96.82

-

-

96.82

20010604-P

KE/SPT/PH03

P

Lupin Lab. Ltd,
India

62.86

3.33

62.86

-

97.90

99.82

98.08

98.60

-

-

98.60

20010604-S

KE/SPT/PH03

P

Lupin Lab. Ltd,
India

90.89

1.40

-

90.89

102.01

104.89

101.41

102.77

-

-

102.77

20010605-P

KE/SPT/PH01

P

Universal
Pharmacy Ltd,
Kenya

15.88

10.40

15.88

-

100.84

99.99

100.49

100.44

-

-

100.44

20010605-S

KE/SPT/PH01

P

Universal
Pharmacy Ltd,
Kenya

83.12

3.42

-

83.12

100.17

99.18

100.19

99.85

-

-

99.85

20010607-P

KE/SPT/DH01

DH

Dawa Pharm Ltd,
Kenya

0.00

-

0.00

-

96.06

98.79

99.34

98.06

-

-

98.06

20010607-S

KE/SPT/DH01

DH

Dawa Pharm Ltd,
Kenya

94.68

2.63

-

94.68

99.39

100.75

100.51

100.22

-

-

100.22

20010608-P

KE/SPT/SH8

S

-

55.25

2.54

55.25

-

96.22

94.76

94.80

95.26

-

-

95.26

20010608-S

KE/SPT/SH8

S

-

90.38

1.75

-

90.38

99.67

100.58

99.89

100.05

-

-

100.05

20010609-P

KE/SPT/HC01

HC

Torrent Pharm,
India

21.81

9.18

21.81

-

102.42

104.80

99.62

102.28

-

-

102.28

20010609-S

KE/SPT/HC01

HC

Torrent Pharm,
India

97.77

3.40

-

97.77

102.57

103.12

102.90

102.86

-

-

102.86

20010610-P

KE/SPT/SH02

S

IPCA Lab. Ltd,
India

54.06

5.15

54.06

-

97.11

99.35

98.23

98.23

-

-

98.23

20010610-S

KE/SPT/SH02

S

IPCA Lab. Ltd,
India

86.73

3.50

-

86.73

100.31

100.85

101.09

100.75

-

-

100.75

20010613-P

KE/SPT/DS01

DMS

Laboratory & Allied Ltd, Kenya

56.40

3.06

56.40

-

95.54

95.69

-

95.62

-

-

95.62

20010613-S

KE/SPT/DS01

DMS

Laboratory & Allied Ltd, Kenya

95.47

2.32

95.47

-

97.96

99.22

-

98.59

-

-

98.59

20010614-P

KE/SPT/CS01

DMS

Kenya Allied Ltd

17.04

11.70

17.04

-

92.87

89.67

88.61

90.38

-

-

90.38

20010614-S

KE/SPT/CS01

DMS

Kenya Allied Ltd

47.78

8.09

47.78

-

95.38

98.08

98.61

97.36

-

-

97.36

20010618-P

KE/SPT/TH01

TH

Elys Chemical,
Kenya

52.03

3.08

52.03

-

100.29

99.43

101.14

100.29

-

-

100.29

20010618-S

KE/SPT/TH01

TH

Elys Chemical,
Kenya

98.38

1.40

-

98.38

101.18

99.42

101.54

100.71

-

-

100.71

20010620-P

KE/SPT/VE01

SV

Laboratory & Allied Ltd, Kenya

45.42

2.12

45.42

-

100.18

104.28

99.59

101.35

-

-

101.35

20010620-S

KE/SPT/VE01

SV

Laboratory & Allied Ltd, Kenya

81.37

2.33

-

81.37

99.03

103.52

94.60

99.05

-

-

99.05

20010625-P

KE/SPT/SH03

S

Cosmos Ltd, Kenya

65.58

7.09

-

65.58

97.78

94.21

-

96.00

-

-

96.00

20010625-S

KE/SPT/SH03

S

Cosmos Ltd, Kenya

93.70

4.19

-

93.70

100.34

100.06

-

100.20

-

-

100.20

REF NO: Reference number

RSD: Related standard deviation

CP: Collection point

   

DH: District hospital

HC: Health centre

P: Pharmacy

SV: Street vendor

S: Shop

TH: Teaching hospital

DMS: District medical stores

P: Pyrimethamine

S: Sulphadoxine

 
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