Application Highlight: Loss on Drying App Allows for Easy Pharma Testing of Tablets and Capsules

Loss on Drying is a back-weighing application used to determine the amount of volatile matter present in tablets, capsules or bulky material. Samples are weighed before and after treatment, and the weight difference is measured.  

According to USP the “dry to constant weight,” or according to European Pharmacopoeia (PhEur) the “dried to constant mass” or “ignited to constant mass” weight value of pharmaceutical products is to be measured. The USP defines that two consecutive weighings must not differ by more than 0.50 mg per g of sample, whereas the PhEur specifies that two consecutive weighings must not differ by more than 0.5 mg in total to consider the sample as dried to constant weight or mass.  

In the Cubis® II application, the administrator selects between the test procedure according to USP or PhEur, and the sample type - tablet or capsule. Due to the different definition of allowed weight difference, the selection determines the mode, or how the software application considers samples to have passed or failed the test. 

Commonly Asked Questions:  

  • How does loss on drying differ from Karl Fischer titration?
      
    • The Karl Fischer titration method determines only sample’s water content. This may include water from crystallization and surface absorption but does not factor in any other substances. Loss on drying also factors in the presence of volatile impurities. 
  • Why is loss on drying testing important?
     
    • Substances to be compounded and used in prescriptions must not only be free of impurities, but also be measured with precision. The nature of all involved substances must be known exactly.  

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