Friday, August 22, 2014
Analytical Methods to Detect Adulteration Minimize

This page is designed to be a repository for analytical methods that can detect intentional adulteration of raw materials, otherwise known as economically motivated adulteration.  These methods are not designed to look for low level impurities or to serve as absolute protection against adulteration.  Each firm adopting these methods must recognize their limitations and understand that no detection method will ever provide 100% detectability or protection against adulteration.  Anyone can download these methods, but we ask that if suspected adulteration is detected that this information is shared with regulatory agencies and Rx-360, so others can be alerted and implement measures to protect the patients they serve.

 

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Glycerin Minimize
 TitleOwnerCategoryModified DateSize 
USP Glycerin MonographMartin VanTrieste 5/22/200926.50 KBDownload
FDA Glycerin GuidanceMartin VanTrieste 5/22/200936.13 KBDownload
  

Heparin Minimize
 TitleOwnerCategoryModified DateSize 
Proposed USP Heparin Sodium Injecion MonographMartin VanTrieste 5/18/200948.92 KBDownload
Proposed USP Heparin Sodium MonographMartin VanTrieste 5/18/2009103.25 KBDownload
EDQM Heparin Testing RecomendationMartin VanTrieste 5/18/20091.29 MBDownload
Current USP Heparin Calcium MonographMartin VanTrieste 5/18/200925.42 KBDownload
Current USP Heparin Sodium MonographMartin VanTrieste 5/18/200938.11 KBDownload
  

Acetonitrile Minimize
 TitleOwnerCategoryModified DateSize 
Acetonitrile Adulteration Detection MethodMartin VanTrieste 5/20/2009122.50 KBDownload
  

FDA Melamine Guidance Minimize
  

 

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