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Extractables & Leachables...

Quantex Laboratories offers full analytical support for extractables and leachables testing.  Extractables and leachables are chemicals that can be released or migrate from product or packaging components, such as rubber, plastic, and glass under various conditions of normal use, that have the potential to contaminate a drug.  We have comprehensive expertise developing and validating methods for the determination of extractables and leachables in various drug products.

Our scientists leverage their knowledge and experience in developing and validating methods to identify extractables and leachables. Analytical instrumentation which includes GC/MS, LC/MS, LC/MS/MS, HPLC and many others, provides us with the tools necessary to characterize, identify, and quantify the extractables and leachables in drug products and medical devices.

Whatever your product requirements, Quantex can provide the analytical services to support  all phases of product development. 

Click here to learn more

 
Sources...
Sources of extractables and leachables include:
bullet Plastic components
bullet Coatings
bullet Elastomers
bullet Antioxidants
bullet Stabilizers
bullet Accelerants
bullet Metal Oxides.
bullet Vulcanizing agents.
 
Methods...
Specific examples of methods include:
bullet Metals by ICP.
bullet Phthalates by GC/MS.
bullet Polycyclic aromatics by HPLC and GC/MS.

 
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