Table 3.
Disintegration test | |||||
---|---|---|---|---|---|
|
|||||
Generic name | Manufacturer | Batch number | Tested n |
Failed n |
Time range* min |
Isoniazid | PhC Romat | 010113 | 24 | 0 | 12–15 |
020113 | |||||
290213 | |||||
190213 | |||||
Rifampicin | PhC Romat | 50212, 30212, 20112, 30113, 220513, 361212 | 60 | 0 | 5–11 |
20113, 401212, 340913, 300613 | |||||
Ethambutol | Macleods | FEL 105A† | 18 | 18 | 52–58 |
FEL 107A† | 18 | 18 | 56–58 | ||
FEL 108A† | 18 | 18 | 55–59 | ||
Ethambutol | Lupin | BL10018‡ | 12 | 12 | 58 |
Pyrazinamide | Lupin | DN20021, DN20022 | 42 | 0 | 3–5 |
DN10026, DN10036 | |||||
DN10027, DN20028 DN20010A | |||||
Ethionamide | Lupin | CH 20002 A‡ | 12 | 12 | 50 |
Prothionamide | Lupin | A300429, A300438 | 30 | 0 | 10–11 |
A300439, A300346 DN28030 | |||||
Cycloserine | Global Pharm | 30113, 521212 | 24 | 0 | 4–7 |
220513,190513 | |||||
Ofloxacin | Global Pharm | 40112§ | 12 | 12 | 53–56 |
Levofloxacin | Chimfarm | 160712, 70512 | 12 | 0 | 5–20 |
Moxifloxacin | MSN Laboratories | 41302200, 41301212 | 12 | 0 | 6 |
Amoxicillin, clavulanic acid | Unichem Laboratories | BMVM12051 BMVM13020 BMVM13005 | 18 | 0 | 22–30 |
Total | 312 | 90 |
Should be <30 min.
Three re-tests of the batch.
Two re-tests of the batch.