How One Might Experimentally Determine if Container Closure Systems and Their Components and Materials of Construction Contribute Elemental Impurities To Packaged Pharmaceutical Drug Products

References

1. 1.↵
   Guidance for Industry: Q3D Elemental Impurities. U.S. Department of Health and Human Services, Food and Drug Administration. September, 2015.
2. 2.↵
   <232> Elemental Impurities – Limits. USP 41; pp. 6147–6151. Official from August 1, 2018.
3. 3.↵
   1. Jenke D.R.,
   2. Stults C.L.M.,
   3. Paskiet D.M.,
   4. Ball D.J.,
   5. Nagao L.M.

   Materials in Manufacturing and Packaging Systems as Sources of Elemental Impurities in Packaged Drug Products: A Literature Review. PDA J. Pharm. Sci. Technol. 2015, 69 (1), 1–48.

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4. 4.↵
   <233> Elemental Impurities – Procedures. USP 41; pp. 6151–6155. Official from August 1, 2018.