Preservative efficacy testing
Standard / Test method
Ph. Eur. 5.1.3
Testing of antimicrobial preservation efficacy in accordance with Ph. Eur. 5.1.3 under defined microbiological test conditions.
Overview
Chapter 5.1.3 of the European Pharmacopoeia, "Efficacy of antimicrobial preservation", describes a test method for assessing the efficacy of antimicrobial preservation in suitable pharmaceutical preparations subjected to a defined microbial challenge.
During testing, viable counts of defined test organisms are measured at specified intervals. The results are assessed against the applicable microbiological acceptance criteria for the preparation.
Testing in accordance with Ph. Eur. 5.1.3 must meet the applicable requirements for test organisms, inoculum levels, sampling intervals and acceptance criteria. Modified conditions for specific research or development questions can be discussed as adapted studies based on Ph. Eur. 5.1.3. These must be clearly distinguished from testing in accordance with the pharmacopoeial requirements.
Typical applications
Preserved formulations
For suitable pharmaceutical formulations whose antimicrobial preservation is to be assessed using a defined test method.
Preservation systems
For assessing whether a preservation system supports the microbiological stability of the tested formulation.
Microbiological assessment
For assessing changes in viable counts of defined test organisms over specified test intervals.
Frequently asked questions
What is Ph. Eur. 5.1.3 suitable for?
Ph. Eur. 5.1.3 is used to assess antimicrobial preservation in suitable pharmaceutical preparations. Viable counts of defined test organisms are measured at specified intervals and assessed against the applicable acceptance criteria.
What does the test assess?
The test assesses whether the preparation is adequately preserved against a defined microbial challenge. Assessment is based on changes in viable counts of the test organisms and the acceptance criteria applicable to the preparation.
Does this test constitute pharmaceutical product approval or release?
No. The test provides a microbiological assessment in accordance with Ph. Eur. 5.1.3. It does not replace a regulatory assessment, marketing authorisation or pharmaceutical product release.
How does Ph. Eur. 5.1.3 differ from DIN EN ISO 11930?
DIN EN ISO 11930 is used to evaluate the antimicrobial protection of cosmetic products. Ph. Eur. 5.1.3 assesses antimicrobial preservation in pharmaceutical preparations using its own procedure and acceptance criteria. The appropriate method depends on the product type, study objective and applicable testing requirements.
Can test parameters be adapted?
Product-specific requirements are reviewed before testing. Testing described as being in accordance with Ph. Eur. 5.1.3 must meet the applicable pharmacopoeial requirements. Modified test organisms, inoculum levels, sampling intervals or other conditions can be discussed for specific research or development questions. Such studies are identified as adapted tests based on Ph. Eur. 5.1.3.