Identification, analysis and safety assessment of leachables and extractables

Author:

Jenke Dennis

Publisher

Elsevier BV

Subject

Spectroscopy,Analytical Chemistry

Reference60 articles.

1. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonized Tripartite Guideline: Impurities in New Drug Products. Q3B(R2). Current Step 4 Version, dated 2 June 2006.

2. Simulated leaching (migration) study for a model container-closure system applicable to parenteral and ophthalmic drug products (PODPs);Jenke;PDA J. Pharm. Sci. Technol.,2017

3. USP <1664>, Assessment of drug product leachables associated with pharmaceutical packaging/delivery system. United States Pharmacopeia; First Supplement to USP 38-NF 33, pp. 7181–7193, official from August 1, 2015.

4. USP <1663>, Assessment of extractables associated with pharmaceutical packaging/delivery system. United States Pharmacopeia; First Supplement to USP 38-NF 33, pp. 7166–7180, official from August 1, 2015.

5. Extractables: the controlled extraction study;Feinberg,2012

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