Complete Monograph Methods

Solutions for regulated Pharmaceutical Instrumental Analysis Methods with HPLC, FTIR, KF, AAS and ICP

This compilation presents complete solutions for regulated pharmaceutical instrumental analysis with focus on the testing of both generic as well as ethical small molecule drugs. All highlighted methods (18 in total) follow their current USP37-NF32 monographs, and all are compliant with requirements in the upcoming USP 38-NF33.

You will find :

  • HPLC and UHPLC methods for active pharmaceutical ingredient (API) assays;
  • their related substances (impurity profiling) as well as dissolution testing of a formulated drug (Esomeprazole delayed release capsules).
  • Karl Fischer (KF) methods for water determination;
  • Atomic Absorption Spectroscopy (AAS), Inductively Coupled Plasma (ICP) methods for metal content determination, and FTIR analysis for identification purposes.
  • A new LC-MS procedure for impurity profiling of Olmesartan medoxomil, but this is not an active USP method.

All methods are compliant with the system suitability criteria of each corresponding monograph.

In all examples, we have used high quality products from Merck Millipore which easily can be used for your needs in validated pharmaceutical quality control.

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