Table 2 |
||||||
|
Analytical results of the antimalarial samples purchased from the informal market in Congo, Burundi and Angola. |
||||||
| 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 |
| % Dissolved5 (%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 |
|||||
|
|
||||||
|
1Qc#, Qb#, Qa#: Quinine tablet samples from Congo, Burundi and Angola, respectively Ca#: Chloroquine tablet samples from Angola Ma#: Mefloquine tablet samples from Angola SPc#: Sulphadoxine and pyrimethamine tablet samples from Congo 2 The samples were purchased in August 2005 3 Declared Producer Origin Country 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. 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. NA: not available IS: in specifications OOS: out of specifications |
||||||
|
Gaudiano et al. Malaria Journal 2007 6:22 doi:10.1186/1475-2875-6-22 |
||||||
