Extractables and Leachables Testing for Pharmaceutical Products

EXTRACTABLES & LEACHABLES TESTING OF PHARMACEUTICAL AND COSMETICS

Over the years, the importance of extractables and leachables testing in the pharmaceutical industry has grown significantly. Similarly for cosmetics too, the concern over extractables and leachables has become a crucial aspect to look into.
When a drug product container-closure system releases the chemicals, the drug product possesses the risk of toxicity. The toxicity affects the stability and tampers the product’s efficacy.
Even the global RA requirements have emphasized the importance of extractables and leachables testing in the pharma industry. The regulatory bodies like the US Food and Drug Administration (FDA) and The European Medicines Agency (EMA) also check the interactions between the manufacturing components, drug delivery devices and container-closure systems, and the final product. Failing to do so, can result in failure to receive RA approval, thereby creating a negative impact on the manufacturing industry.

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WHAT IS EXTRACTABLES & LEACHABLES TESTING

According to the definition of FDA, extractables are organic and inorganic chemical species that can be released from the surfaces of components used in the manufacture and storage of drug products under laboratory conditions.
Whereas, leachables are organic and inorganic chemical moieties that can be released from the surfaces of components used in the manufacture and storage of drug products under conditions of normal use.
Extractables and leachables testing determines the purity of the final product- then be it medicine for consumption purpose or cosmetic product meant for application.

PARAMETERS TESTED IN EXTRACTABLES & LEACHABLES

At Anacon Laboratories, we employ extensive methodology to identify the potential contaminants that migrate from containers and process components made from materials like polymers, plastics, elastomers, etc. Apart from this, we also perform the following tests

Volatile Organics and Semi-volatile Organics
Polar, non-volatile
Inorganic

WHY ANACON LABORATORIES?

Anacon Laboratories offer the best testing services of pharmaceutical and cosmetic testing. Our experts’ study extractable evaluations of packaging components, leachable evaluations of the aged drug product, and leachable evaluations of manufacturing surfaces and interfaces.
Our team takes into account every tiny detail, and we have set in place state-of-the-art technology in our laboratories. We understand the importance of extractables and leachables testing, and this is the reason why we ensure there are no stones left unturned to get you the most detailed, relevant, and accurate test results in a set timeframe.

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