Leachables Evaluation for Bulk Drug Substance

References

1. 1.↵
   Biopharmaceutical Process Extractables Core Team, Evaluation of extractables from product-control surfaces. BioPharm Int. 2002, December, 22– 34.
2. 2.↵
   International Committee on Harmonisation (ICH); Food and Drug Administration. Guidance for Industry, Q3C “Impurities: Residual Solvents”, 12 1997.
3. 3.↵
   The United States Pharmacopeia. 〈88〉 Biological Reactivity Tests, In Vivo, USP30-NF25, 20852; United States Pharmacopeial Convention, Inc.: Rockville, MD, 2007.