1. Q3A(R) Impurities in New Drug Substances; ICH Harmonized Tripartite Guideline; International Conference On Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use; February 7, 2002, 1–11 .
2. Q3B(R) Impurities in New Drug Products; Guidance for Industry; U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CEDER); Rockville, MD, November 2003; 1–7 .
3. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CEDER) and Center for Biologics Evaluation and Research (CBER); Rockville, MD,Container Closure Systems for Packaging Human Drugs and Biologics;Guidance for Industry; May 1999; 1–41 .
4. <661> Containers - Plastics. inThe United States Pharmacopeia, USP 31; USP Convention, Inc. : Rockville , MD , 2008; 251–255.
5. <381> Elastomeric Closures for Injections . inThe United States Pharmacopeia, USP 31; USP Convention, Inc. : Rockville , MD , 2008 ; 144 – 145 .