Extractable and leachable studies are designed to identify chemicals released or migrated from product or packaging components, such as rubber, plastic, and glass under various conditions of normal use. Extractables and leachables may be composed of both organic substances (packaging raw materials, additives, stabilizers, accelerants, breakdown and reaction products) and inorganic substances (metal oxides, acids, etc.). These studies are performed on:

• Inhalation devices
• Injectables
• Implantable devices
• Ocular and nasal delivery systems
• Packaging components (1°, 2°, 3°)
• Other products

Cyanta leverages its experience with polymers, metals, pharmaceutical products and other matrices to identify the extractable/leachable profile of your medical device. Our analytical equipment, which includes GC/MS, LC/MSⁿ, HPLC and many others, provides us with the tools necessary to characterize, identify, and quantify the extractables and leachables in your product.

We support your extractables and leachables program by performing the following services:

Investigation Analysis/Survey Development
Cyanta can perform probe or full chemical surveys of your packaging materials to determine representative extractable profiles. While survey methods are available, additional procedures can be developed, optimized, and validated to support your extractable profile needs.

Identify Extractables/ Method Development/ Toxicological Review
Cyanta can help you determine appropriate detection levels and to develop identification and characterization packages specific to your extractable profiles. Using GC/MS, LC/MS, LC/MS/MS, IT/MS, headspace MS, ICP, NMR and other techniques, Cyanta can identify your most complex extractables for safety assessment by a toxicologist.

Method Validation
As needed, specialized methods can be developed and validated for extractables for use as part of a packaging material quality control system. In addition, lot surveys can be performed to determine the typical variability in packaging material lots to make sure your profile is representative of your packaging material and not the exception.

Leachables Method and Analysis
Based on extractables data, Cyanta can develop a validated method battery suitable for your stability testing needs. Based on our expertise, we can assist you with setting specifications for leachables that ensure the long-term quality of your product.

Cyanta can develop an extractable and leachable analysis strategy that works within your specific regulatory, timing, and cost needs while keeping you in control of the risk assessment process.