Alternative solvents for extractables and leachables evaluation
Every new drug application is expected to include some form of extractables profiling and leachables evaluation for the components at highest risk and in closest contact with the drug. In addition to final container-closure systems, components associated with the bioprocessing system of biologics ar...
Saved in:
| Published in: | Pharmaceutical Technology Vol. 37; no. 8; p. 51 |
|---|---|
| Main Authors: | , , , , |
| Format: | Magazine Article Trade Publication Article |
| Language: | English |
| Published: |
Monmouth Junction
MJH Life Sciences Media
01-08-2013
MultiMedia Healthcare Inc |
| Subjects: | |
| Online Access: | Get full text |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| Summary: | Every new drug application is expected to include some form of extractables profiling and leachables evaluation for the components at highest risk and in closest contact with the drug. In addition to final container-closure systems, components associated with the bioprocessing system of biologics are considered at risk for leachables. Shelf life, storage temperature, and conditions of real-time use of a component under evaluation with the process stream, drug substance, or a final drug product are all key factors in designing appropriate extractables studies, simulation studies, and ultimately leachables studies. For bioprocessing components, initial extractables screening involves filling or immersing the component in a variety of model solvents that more closely represent the formulation and exaggerate the conditions of real-time use. When comparing extraction efficiency between the various solvents for extractable screening studies, it is recommended that IPA be used as a worst-case solvent in cases for which surfactunts are of interest. |
|---|---|
| ISSN: | 1543-2521 2150-7376 |