A recent article in the journal Pediatrics has raised further questions about the presence of phthalates in the environment. They note that certain phthalates, found in numerous baby care products, may lead to developmental and reproductive toxicity in infants.

Phthalates are synthetic chemicals that are used to make vinyl products flexible and soft. They also make products like nail polish harder to chip and make fragrances last longer. They are found in many industrial and common household items, including PVC plastics, cosmetics, personal care products (including most lotions, shampoos and powders), plastic toys, vinyl products and almost all products with fragrance. Phthalates are also used in medical devices, and numerous items our homes and cars. Essentially, phthalates are everywhere.

Phthalate testing is problematic due to their wide spread use and background levels can lead to false positive results.  Therefore the laboratory must eliminate background sources of phthalates and ensure that quality control data supports that the analysis is free of these interferences. Although there are a number of analytical testing alternatives, the most common way for a laboratory to test for phthalates is using a gas chromatograph mass spectrometer operated in selected ion monitoring mode (GC/MS/SIM). This GC/MS/SIM technique is currently being used by Columbia Analytical Services in similar studies investigating phthalates in medications, ambient air, and other applications related to human health risk. Columbia Analytical has performed analytical testing for phthalates for over 20 years.

For more information on testing for phthalates, contact Jeff Christian, Columbia Analytical Services, Inc. at 360-577-7222.

Chemical structure of butyl benzyl phthalate

The CAS - Kelso laboratory is cGMP compliant and registered with the FDA. CAS’ comprehensive quality assurance and ethics programs ensure that data produced is scientifically sound, legally defensible, and accurately documented. To ensure that your analytical needs are met, your project is managed by one of our in-house project chemists. Our capabilities, expertise, and services include the following:

Monograph Testing – USP/NF, EP, JP, and BP monograph testing. This includes raw material and final product testing. An example of this includes Organic Volatile Impurities testing by USP <467>. CAS can also complete testing using client supplied methodology.

Method Development and Validation – Our professional scientists have extensive experience in analytical chemistry and can assist in method development and validation for pharmaceutical testing. Methods are validated to current ICH and USP guidelines.

Engineering Studies/Process Validation – Scientists at CAS are accustomed to non-routine testing and have the knowledge and resources to solve your analytical problems. Examples of this include analytical support for cleaning studies or manufacturing processes.

Stability Testing – CAS provides analytical support to your stability study testing. This may include assay testing, physical testing, and impurity and degradation product monitoring. This also includes development and validation of stability indicating assays.

CAS has extensive instrumental testing capabilities. CAS’ general analytical capabilities include the following: Karl Fischer, Gas Chromatography, Gas Chromatography/Mass Spectrometry, High- Performance Liquid Chromatography, Inductively Coupled Plasma/Mass Spectrometry, Inductively Coupled Plasma/ Atomic Emission Spectroscopy, Atomic Absorption, LC/MS/MS (currently being installed), and many general chemistry techniques.

Our services will help to keep your turn-around-times ahead of schedule, costs under budget, and most importantly meet cGMP quality and regulatory requirements.

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