challenge test

For some pharmaceutical dosage forms, especially liquid and semisolid aqueous formulations, the use of preservatives is needed to prevent the microbial proliferation up to its expiry date.

According to the Guidelines, the use of preservatives must be justified and its concentration must be the minimum to guarantee its effectiveness throughout the shelf-life of the product. For this reason, the efficacy of antimicrobial preservation must be verified over the period of validity.

What is needed for these studies?

For this test the dosage form must be challenged with specific pathogenic microorganisms. Specific bacterial strains according to the Chapter 5.1.3. Efficacy of antimicrobial preservation of European Pharmacopoeia are needed. Additionally, the GMP certification is also necessary.

What Netpharmalab offers to you…

At Netpharmalab we carry out the efficacy antimicrobial preservation test in any pharmaceutical dosage form ensuring the compliance with the European Pharmacopoeia requirements.