| Extensive
Pharmaceutical Testing |
Reliable Chemical and Physical Characterization |
 USP <601> characterization |
| Primary particle size determination |
| Bulk density |
| Appearance and color |
| Dehydrated alcohol content |
| Drug content assay |
| Device counters |
| Impurities and degradation products determination |
| Leak rate |
| Identification |
| Priming |
| Water content (KF, GC) |
| Net content or fill weight |
| Related substances methods |
| Microscopic evaluation |
| Temperature cycling |
| Foreign particulate matter |
|
| Method development, optimization and validation |
| Formulation evaluation studies |
| Drug product characterization |
| Stability testing and storage (CDER/ICH guidelines) |
| Extractables/leachables studies |
| Impurities and degradation products determination |
| |
| Advanced Device Evaluation |
| Aerodynamic particle size distribution by impaction |
| Droplet size determination |
| Dispersability by laser diffraction and cascade impaction |
| Dose content uniformity |
| Pressure and preservatives |
| Retention of prime |
| Shot weight and spacer evaluation |
| Leak rate |
| Spray pattern |
| Valve delivery |
| Emitted/delivered dose |
| Cyr test (storage orientation) |
| Extractables/leachables studies |
|
