Table 7.
Stability results under “accelerated” conditions (AC) and “stress” conditions (SC) for samples stored in glass containers*
| Absorbance variation (%) |
||||||||
|---|---|---|---|---|---|---|---|---|
| paroxetine |
hydrocortisone acetate |
ketoprofen |
nifedipine |
|||||
| AC | SC | AC | SC | AC | SC | AC | SC | |
|
Active pharmaceutical ingredient: |
||||||||
|
T1 (30 d) |
+3 |
+5 |
+0,5 |
+1 |
-1 |
+14* |
+1 |
-42* |
|
T2 (60 d) |
+3 |
+17* |
+0,7 |
+13* |
-1,5 |
+23* |
+0,6 |
-47* |
|
T3 (90 d) |
+2.5 |
+24* |
+0.7 |
+19* |
+1 |
+32* |
+1.5 |
-52* |
|
Galenics: |
||||||||
|
T1 (30 d) |
-1 |
+6 |
+0,2 |
+7 |
-0,3 |
+34* |
-3 |
-64* |
|
T2 (60 d) |
-4 |
+33* |
+0,6 |
+18* |
-0,6 |
+91* |
-2 |
-72* |
| T3 (90 d) | -4.5 | +42* | +0.8 | +59* | -0.9 | +99* | -2.5 | -83* |
*Results are reported as percentual variation of absorbance values (arithmetic mean of 10 analyses) between sample concentration and standard. Out-of-specification values are identified with an asterisk.