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Table 2 Analytical results of the antimalarial samples purchased from the informal market in Congo, Burundi and Angola.

From: Medicines informal market in Congo, Burundi and Angola: counterfeit and sub-standard antimalarials

Sample1

Packaging/Exp. Date2

Origin3

% Assay (%RSD)

Uniformity of Mass

Disintegration Test

% Dissolved4 (%RSD)

Qc1

In the "Essential Drugs Programme-WHO" pot/02-2007

Cyprus

97.0 (0.9)

IS

IS

98 (1)

Qc4

loose tablets/08-2008

Congo

99.8 (0.4)

IS

IS

96 (1)

Qc6

loose tablets/07-2007

Holland

102.7 (0.7)

IS

IS

100 (2)

Qc10

loose tablets/04-2008

Congo

100.3 (0.8)

IS

IS

96 (2)

Qc11

loose tablets/10-2007

Congo

99.5 (0.7)

OOS

IS

96 (1)

Qc12

loose tablets/08-2006

Congo

98.5 (0.2)

IS

IS

101 (1)

Qc14

loose tablets/NA

NA4

96 (2)

IS

IS

75 (5) OOS

Qc17

loose tablets/NA

NA

88.6 (0.6) OOS

IS

IS

58 (7) OOS

Qc18

loose tablets/NA

NA

97.4 (0.8)

IS

IS

72.3 (0.6) OOS

Qc20

in blister/01-2007

India

95.2 (0.4)

IS

IS

99 (4)

Qb1

loose tablets/11-2009

NA

99.0 (0.5)

IS

IS

96 (1)

Qb4

in blister/05-2008

Burundi

99 (1)

IS

IS

101 (2)

Qb5

loose tablets/05-2008

NA

Different Active

OOS

IS

30 (8) OOS

Qb6

loose tablets/03-2008

NA

95.9 (0.3)

IS

IS

88 (4)

Qa3

in blister and secondary packaging/08-2008

India

97.4 (0.8)

IS

IS

50 (5) OOS

Qa5

in blister/10-2007

India

98 (1)

IS

IS

98 (2)

Ma4

in blister/06-2006

Brazil

102.6 (0.9)

IS

IS

Not evaluated

Ma6

in blister and secondary packaging/08-2007

Cyprus

102.4 (0.8)

Not evaluated

Not evaluated

Not evaluated

Ca1

in blister and secondary packaging/08-2007

India

102 (2)

IS

IS

26 (3) OOS

Ca2

in blister/08-2007

India

102.8 (0.7)

IS

IS

75 (7) OOS

      

% Dissolved 5 (%RSD)

SPc2

tablets loose/11-2006

Malta

S = 94.8 (0.6)

IS

IS

S = 79.5 (0.2)

   

P = 99.1 (0.1)

  

P = 73 (2)

SPc3

in blister and secondary packaging/06-2007

India

S = 96.3 (0.3)

IS

IS

S = 97 (5)

   

P = 100.3 (0.2)

  

P = 67.9 (0.6)

SPc5

in blister and secondary packaging/02-2007

India

S = 98 (1)

IS

IS

S = 99 (1)

   

P = 100.9 (0.6)

  

P = 72 (1)

SPc7

tablets loose/10-2008

Cyprus

S = 95.9 (0.6)

IS

IS

S = 95 (3)

   

P = 97.9 (0.4)

  

P = 73 (3)

SPc8

tablets loose/NA

NA

S = 94.0 (0.2)

IS

IS

S = 57 (3) OOS

   

P = 94.1 (0.6)

  

P = 24 (1) OOS

SPc9

in blister and secondary packaging/06-2007

India

S = 96 (1)

IS

IS

S = 84 (3)

   

P = 102.7 (0.1)

  

P = 52 (2) OOS

SPc13

loose tablets/NA

NA

S = 93.3 (0.4)

IS

IS

S = 80.6 (0.7)

   

P = 104.6 (0.6)

  

P = 53 (7) OOS

SPc15

loose tablets/NA

NA

S = 95 (1)

IS

IS

S = 72 (1)

   

P = 100.7 (0.9)

  

P = 45 (3) OOS

SPc16

loose tablets/NA

NA

S = 97.3 (0.2)

IS

IS

S = 95 (1)

   

P = 100.8 (0.5)

  

P = 55 (5)OOS

SPc19

in blister/NA

China

S = 93.8 (0.4)

IS

IS

S = 47 (2)OOS

   

P = 99.1 (0.8)

  

P = 18.6 (0.6)OOS

  1. 1Qc#, Qb#, Qa#: Quinine tablet samples from Congo, Burundi and Angola, respectively
  2. Ca#: Chloroquine tablet samples from Angola
  3. Ma#: Mefloquine tablet samples from Angola
  4. SPc#: Sulphadoxine and pyrimethamine tablet samples from Congo
  5. 2 The samples were purchased in August 2005
  6. 3 Declared Producer Origin Country
  7. 4 USP tolerances for quinine sulphate and chloroquine phosphate tablets: not less than 75%(Q) (equivalent to "not less than 80%") of the labelled amount is dissolved in 45 minutes.
  8. 5 USP tolerances for sulphadoxine and pyrimethamine tablets: not less than 60%(Q) (equivalent to "not less than 65%") of the labelled amount is dissolved in 30 minutes.
  9. NA: not available
  10. IS: in specifications
  11. OOS: out of specifications