Stability storage and
stability testing

We carry out long-term, short-term and ongoing stability storage of finished phar­ma­ceu­tical prod­ucts and active substances in accor­dance with current ICH guide­lines and GMP require­ments. Clients engage us to test storage and in-use stability, monitor batches on the market (ongoing stability) and test dura­bility in connec­tion with variations.

After the storage period is completed, our analysts set to work according to the stability testing plan or the client’s spec­i­fi­ca­tions. We test all forms used for admin­is­tering phar­ma­ceu­ti­cals – from solid forms such as tablets and capsules and semi-solid forms such as creams and oint­ments through to liquids.

Stan­dard­ised processes for reli­able stability testing:

  • Testing plans that meet regu­la­tory requirements
  • Narcotic drugs licence in accor­dance with Section 3 of the German Narcotic Drugs Act (BtMG)
  • Import licence for inter­na­tional projects
  • Storage in accor­dance with ICH conditions
  • Coor­di­na­tion, analysis, assess­ment and reports
  • Effi­cient plan­ning and imple­men­ta­tion of ongoing stability tests

Our climate cabi­nets repre­sent all stan­dard­ised climate condi­tions and enable reli­able and effi­cient stability storage.

Stan­dard conditions

  • Climatic zone II (25°C/60% RH)
  • Inter­me­diate condi­tion, climatic zone IVa (30°C/65% RH)
  • Accel­er­ated condi­tion (40°C/75% RH)

Special climatic zones

  • Climatic zone IVb, (30°C/75% RH)

Cold and frozen storage

  • 2°C to 8°C
  • -20°C
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