Publisher
Springer Science and Business Media LLC
Reference41 articles.
1. U.S. Pharmacopea, USP<1664> Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging/Delivery Systems, 2017.
2. U.S. Pahamacopia, USP<661>Plastic Packaging Systems and Their Materials of Construction, 2017.
3. ICH M7(R2) Guideline on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk, 2023.
4. C. B’Hymer, Residual solvent testing: a review of gas-chromatographic and alternative techniques. Pharm. Res. 20(3), 337–344 (2003). https://doi.org/10.1023/a:1022693516409
5. D.R. Jenke, J.M. Jene, M. Poss, J. Story, T. Tsilipetros, A. Odufu, W. Terbush, Accumulation of extractables in buffer solutions from a polyolefin plastic container. Int. J. Pharm. 297(1–2), 120–133 (2005). https://doi.org/10.1016/j.ijpharm.2005.03.010