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Original Articles

Guidelines for the Design, Implementation, and Interpretation of Validations for Chromatographic Methods used to Quantitate Leachables/Extractables in Pharmaceutical Solutions

Pages 3141-3176 | Received 23 Jun 2004, Accepted 24 Jul 2004, Published online: 11 Jun 2009

References

  • 2003 . “ Validation of Compendial Methods ” . In USP 27 2622 – 2625 . Rockville , Maryland : United States Pharmacopeial Convention, Inc. .
  • 1995 . Guideline for Industry. Q2A Text on Validation of Analytical Procedures Rockville , Maryland : US Dept. of Health and Human Services . (Published in the Federal Register, 60 FR 11260, on March 1, 1995.)
  • 1996 . Guideline for Industry. Q2B Validation of Analytical Procedures: Methodology Rockville , Maryland : US Dept. of Health and Human Services . (Published in the Federal Register, 62 FR 27464, on May 19, 1997)

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