Understanding Extractables and Leachables Testing: The Safety Concern in the Administration of Drugs and Medical Devices

Chromak Research posits that the health of patients is as important as the rigorous testing and scrutiny that goes behind pharmaceutical and medical device products. Extractables and leachables testing are an essential part of the procedure as they deal with potential risks that need to be solved in regard to materials that could migrate from other sources i.e. packaging and delivery systems.

What are Extractables and Leachables?

Extractables refer to potentially harmful substances that are encapsulated in polymers, glass, metals, and other elements that can be loosened from the packaging or medical device when subjected to high temperatures or strong chemicals. The effort to explore extractables is a very critical step that seeks to eliminate all possible contaminations in a pharmaceutical product.

Leachables are the materials that get absorbed into the pharmaceutical product during its normal shelf life. These substances are extremely harmful because of the various ways they can be consumed such as oral, inhalation, nasally, and parentally. Knowing what are extractables and leachables helps maintain drug effectiveness and patient safety.

The Significance of Extractables and Leachables Testing

Patients’ safety is becoming one of the concerns for regulatory authorities when it comes to the interaction between drug products and their primary packaging. Extractables and Leachables testing is, thus, vital for:

Regulatory Compliance

New drug applications require extensive Extractables and Leachables (E&L) testing to be performed in accordance with the directions of inspection bodies, such as the FDA and EMA, in order to be accepted.

Product Integrity

Preserving pharmacologically active substances from chemical decomposition by leachable and or removing them from a drug and sophisticated forms.

Patient Safety

The extractables and leachables analysis will help minimize the risks posed by harmful substances that may be encountered.

Analytical Techniques for Extractables and Leachables Studies

At Chromak Research, we have quite several advanced analytical techniques to ensure that we get every extractables and leachables since no single method will guarantee completeness. Some of these methodologies comprise:

For Volatile and semi-volatile organic compounds.

Non-volatile compounds analyses.

For metals.

Organic materials screening of a broad spectrum.

Assists in determining the physical-chemical properties of leachable.

Extractables and Leachables (E&L) Testing conducted by Chromak Research

Studies on Extractables: We conduct and give out an extractable studies report on critical components utilizing multi-extraction as a method of our design. The Analytical Evaluation Threshold (AET) is set by us from the Safety Concern Threshold (SCT). Reports are given with Results as well as the chromatograms.

Studies on Leachables: We create and validate activities per ICH Q2 (R1) instructions pertaining to possible leachable in drug products. It encompasses analysis of stability time point samples to guarantee product claims.

In although Chromak Research implements guidelines and best practice including those from PQRI for OINDP and USP 1663 and 1664, all pharmaceutical products and medical devices are ensured to be safe, of high quality through quality extractables and leachables testing.

Recognizing the elaborate nature of and lack of simplistic extractables and leachables (E&L) studies, we shield patient safety and regulatory standards which aids in the fruitful introduction and the required enduring presence of the pharmaceutical and medical devices in the marketplace.

Choose Chromak Research for Expert Extractables and Leachables Testing

We at Chromak Research have extensive knowledge about extractables and leachables proprietary studies to make them comply with complex industry standards and regulatory requirements. We have been in business for many years and are the top-tier E&L testing providers assisting clients with risk assessments and formulating plans for their products and processes.

Our extractables and leachables studies can be constructed according to USP <665>, <1663>, and <1664>, ISO 10993, and PQRI, as well as BPSA and BPOG documents. We attend to the requirements of the FDA’s CDER/ CBER/CDRH, EMEA, and other authorities.

Our services encompass E&L testing and stability studies while maintaining GMP compliant guidelines. We provide reports displaying instrumental parameters, system suitability, sample chromatograms and tables of results for effortless understanding.

We also provide in-depth toxicology reviews of E&L data to assess the risk the product poses. These and other processes ensure compliance with the required regulations.

Combined with our advanced LC/MS technology, our extractables identification becomes highly accurate. Analysts utilize advanced methods to help with harder-to-identify demystified substances.

Get in touch with Chromak Research to get thorough extractable and leachable testing with the assurance that the regulated aspects of your medical and pharmaceutical products will not be compromised.