Pharmaceutical analysis

Physical, chemical and microbiological analysis of raw materials and final products
Stability testing
We perform stability testing of medicinal products and raw materials. Preparations are stored in high stability climate chambers under the following conditions:
•    Long-term stability 25 ºC/60%RH
•    Short-term stability 30 ºC/65%RH
•    Accelerated stability 40 ºC/75%RH
•    Stability in refrigerator (+2-8 ºC)
•    Storage according to customer specifications
•    A stability plan and, at the end of the test, a stability report is prepared.
During the above tests, the following analyses are performed:
•    Determination of active ingredient content and content uniformity (CU)
•    Determination of contaminants and metabolites
•    Physical analyses (friability, thickness, mass, water content etc.)
•    Dissolution and disintegration tests
•    Determintation of solvent residues
•    Determination of metal content
•    Microbiological analyses
Research and development
We develop analytical methods necessary for the qualification of new preparations and the validation of these methods according to current guidelines.

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