Business challenges
1、 Most of the extractables are unknown, so high-end equipment and experienced analysts are needed for structural identification.
2、 The content of extractable and leachable substance is low, so it needs high precision instrument and equipment.
3、 There are many kinds of drugs, different usage and dosage, and the calculation of analysis and evaluation threshold of extractable and leachable substances is complex.
4、 Toxicological evaluation of extractable and leachable substances requires specialized toxicological experts.
service content
1、 Study on compatibility of drug packaging materials
2、 Study on compatibility of disposable system or components
3、 Study on extractable spectrum of drug packaging materials
4、 Study on the extract of preparation
5、 Development and validation of specific leachables detection methods
6、 Toxicological evaluation and PDE derivation of extractable and leachable substances