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Measuring Elemental Impurities in Pharmaceutical Materials (PDF)

必威体育登录手机The Agilent workflow solution for implementing an elemental impurities analysis capability in compliance with USP / and ICH Q3D.

  • Publication Part Number: 5991-8140EN
  • Created: 16 Oct 2023
  • 2 MB
  • PDF
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Applications
&#24517;&#23041;&#20307;&#32946;&#30331;&#24405;&#25163;&#26426;Validating performance of an Agilent ICP-MS for USP <232>/<233> & ICH Q3D(R2)/Q2(R1) (PDF)

Reducing the time and expense of ICP-MS method development and system validation for measuring elemental impurities in pharmaceuticals

  • Publication Part Number: 5991-8335EN
  • Created: 16 Oct 2023
  • 995 KB
  • PDF
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Applications
&#24517;&#23041;&#20307;&#32946;&#30331;&#24405;&#25163;&#26426;Elemental Impurity Analysis of Sterile Artificial Tear Eye Drops Following USP <232>/<233> and ICH Q3D(R2)/Q2(R1) Protocols on the Agilent 7900 ICP-MS (PDF)

This application note describes the validation of a procedure for the measurement of elemental impurities in sterile artificial tear eye drops (SATED).

  • Publication Part Number: 5994-1561EN
  • Created: 16 Oct 2023
  • 1 MB
  • PDF
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Case Studies
&#24517;&#23041;&#20307;&#32946;&#30331;&#24405;&#25163;&#26426;Regulatory compliance with Agilent ICP-MS MassHunter and OpenLAB Server (PDF)

&#24517;&#23041;&#20307;&#32946;&#30331;&#24405;&#25163;&#26426;White paper discussing how Agilent's MassHunter & OpenLAB Server software supports compliance to GLP & GMP regulations.

  • Publication Part Number: 5991-2593EN
  • Created: 10 Oct 2024
  • 876 KB
  • PDF
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Case Studies
ICH Q3D/USP <233> Elemental Impurities Kit (PDF)

New limits for elemental impurities in pharmaceutical materials and dietary supplements have been released by the USP and ICH.

  • Publication Part Number: 5991-8177EN
  • Created: 17 Jan 2024
  • 196 KB
  • PDF

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