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Elemental Impurities from Stainless Steel

Elemental Impurities from Stainless Steel Grade 316 Stainless Steel is used throughout the pharmaceutical industry for synthesis, processing and packaging.  This material contains the following metals:
  • Chromium (16.5-18.5%)
  • Nickel (10.5-13.5%)
  • Molybdenum (2.0-2.5%)
  • Iron (balance)

Since the limits of Cr, Ni and Mo are controlled by USP <232>, one should consider exposure of a drug product to stainless steel as a potential source of contamination.  The inherent stability of stainless steel in the presence of many pharmaceutical substances reduces the likelihood that it will be a source of contamination.  However, the potential for contamination may be higher for some substances and it should be considered as part of a comprehensive risk-based strategy.

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