| Formulation |
Process Impurities |
Allowable Limit (%) |
Typically Observed (%) |
| Codeine |
Morphine |
0.15 |
0.01-0.1 |
| Hydrocodone |
Codeine |
0.15 |
0-0.1 |
| Hydromorphone |
Morphine
Hydrocodone |
0.15
0.1 |
0-0.025
0-0.025 |
| Morphine |
Codeine |
0.5 |
0.01-0.05 |
| Oxycodone |
Hydrocodone |
1 |
0.02-0.12 |
| Oxymorphone |
Hydromorphone Oxycodone |
0.15 0.5 |
0.03-0.1
0.05-0.4 |
|
