Extractables & Leachables from Packaging: Ensuring Pharmaceutical Safety

What Are Extractables & Leachables

Extractables refer to the chemicals that can be extracted from packaging materials under ideal conditions, such as solvent testing. Leachables are the substances that actually migrate into the drug product during its shelf life and use. Both are critical in assessing potential risks to patient safety.

The identification of extractables and leachables is a regulatory requirement for ensuring that pharmaceutical products remain safe and effective throughout their lifecycle.

Why They Matter

Extractables and leachables can pose significant risks if they are toxic or alter the chemical composition of the drug product. For instance, certain plasticizers used in packaging materials may migrate into the drug solution over time, potentially affecting its stability and efficacy.

Regulatory agencies such as the FDA require extensive testing to ensure that these substances do not exceed safe levels, thereby protecting public health.

How They Are Assessed

Assessment of extractables and leachables involves a series of tests including solvent leaching studies, accelerated stability studies, and analytical methods to identify and quantify the substances. These tests help in understanding the potential risks associated with different packaging materials.

Pharmaceutical companies use these data to select appropriate packaging solutions that minimize the risk of adverse effects on product quality and patient safety.

Real-World Examples

One notable example is the recall of certain pharmaceutical products due to concerns about leachables from plastic containers. Companies must continuously monitor and update their packaging materials to comply with regulatory standards.

Another example involves the use of glass vials for injectable drugs, which are known to have lower extractable levels compared to plastic alternatives.

Frequently asked questions

Try it live

Everything above runs in your browser — open Extractables & Leachables from Packaging and change the parameters while it is running. Nothing is installed, nothing is uploaded, the whole model lives in one tab.