Preservative Efficacy Testing

Preservative efficacy testing is a series of laboratory tests conducted to evaluate the preservatives in pharmaceutical products. The purpose of this testing is to determine whether the preservatives used in products are capable of protecting them from microbial contamination and growth. In other words, preservative efficacy testing is performed to figure out the specific type and smallest amount of preservatives needed to properly preserve pharmaceutical products. This is important to ensure product safety, stability, and effectiveness over time. In general, multiple-dose drug and all aqueous-based products that include ophthalmic, otic, nasal, oral, irrigation, and dialysis fluids should be performed this testing. By the way, preservative efficacy testing is also commonly used to test preservatives in cosmetics and personal care products and foods. At Alfa Chemistry, we offer preservative efficacy testing services for pharmaceutical products to meet regulatory requirements and ensure product quality.

Preservative efficacy testing method at Alfa Chemistry

At Alfa Chemistry, we follow the United States Pharmacopeia (USP)<51>guidelines for preservative efficacy testing. The USP<51>method is a well-recognized standard for evaluating the antimicrobial effectiveness of preservatives in pharmaceutical products.

According to this guideline, preservative efficacy testing can be performed on following four categories of products:

The preservative efficacy testing study evaluates the effectiveness of antimicrobial preservatives on the following organisms:

Process of the preservative efficacy testing involves:

Introducing 5 different test organisms listed above into separate 20 gram portions of the test sample. The initial concentration for each organism ranges from 100,000 to 1,000,000 organisms. The samples are then placed in an incubator at 20-25 °C for a period of 28 days. At intervals of 7, 14 and 28 days (depending on the product category), portions are taken from the samples to assess the remaining viable test organisms and determine the effectiveness of the preservative.

Alfa Chemistry's testing provides three benefits to our customer:

• It can help you ensure that your products are able to resist contamination and microbial growth, thereby extending their shelf life and maintaining their quality.
• It can help you meet regulatory requirements and ensure the safety and effectiveness of your products for consumers.
• It can help identify the most suitable preservative system (preservative type and concentration) for your specific formulation and monitor its effectiveness over time. This can ultimately save you time and resources by preventing product recalls or quality issues.

Sample requirements

Typically, 150 -200 g or 150 -200 ml.

For more information on sample amounts for preservative efficacy testing, please contact us.