The most important point when introducing pharmaceutical products to the market in the pharmaceutical industry is to determine the purity of the final product. This raises the need to determine the impurity profile of the drug.
Previously, this need was only related to impurities resulting from the manufacture and spoilage of a pharmaceutical product. Today, however, the migration of chemical compounds originating from components used in the manufacture and storage of drugs is also being evaluated.
Today, the U.S. Food and Drug Administration (FDA) and other regulatory agencies are increasingly focusing on interactions between various manufacturing components, drug delivery equipment and cap systems, and the final pharmaceutical product. The purpose of these studies is to identify and evaluate the toxicological risks posed by such interactions.
Containers and caps containing drugs must not be reactive, additive or absorbent in a way that would change the safety, content, strength, quality or purity of the drug beyond the specified requirements. Beyond this today, the containers and closures in which drugs are placed must not be extractable or leakproof.
Extractable refers to the organic and inorganic chemical species that can be released from the surfaces of components used in the manufacture and storage of drugs under laboratory conditions (accelerated or exaggerated temperatures, solvents or surface exposure).
The term leachate refers to organic and inorganic chemical species that can be released from the surfaces of components used in the manufacture and storage of medicines under normal use conditions.
There are many resources that contain leakable types, such as:
Species exposed to leakage to consider include:
In short, extractable and leachable drug tests are the pathway to toxicological evaluation. Leakages from the manufacturing and packaging system to pharmaceutical products need to be identified and monitored throughout the shelf life of the product. The results obtained allow for a toxicological assessment of leaks, ensuring patient safety.
Our organization carries out very different testing, analysis, measurement, control and evaluation activities for businesses in various sectors. In these studies, it always follows domestic and foreign standards and applicable legal regulations. Our organization, which has a trained and experienced staff and advanced technological facilities, also provides extractable and leachable drug testing services within the scope of medical drug tests to companies that request it.
To get an appointment, to get more detailed information or to request an evaluation, you can ask us to fill in our form and reach you.
