Validation of a method for determination of extractable additives from a polypropylene material of known composition was performed. A test method was developed based on results of studies outlined in a protocol written by the PQRI Leachable and Extractable Working Group titled “Experimental Protocol for Controlled Extraction Studies on Plastic Test Articles.” The method quantitates three antioxidants in polypropylene extracts using reverse phase HPLC with ultraviolet detection. Validation procedures adhering to ICH guidelines for a quantitative impurity test were referenced. This presentation summarizes the procedures and results of the following challenges that were carried out to validate the test method:
- Specificity
- Linearity and Range
- System Suitability
- Precision – Repeatability
- Limit of Quantitation
- Intermediate Precision
- Accuracy
- Stability
Read the full scientific poster here.
Diane Paskiet
Associate Director – Scientific Affairs
610-594-3401
Diane.Paskiet@westpharma.com
Filed under: Extractables and Leachables, Science Posters Tagged: | extractables, leachables, Plastic, PQRI, stability, validation
