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USP <661>

Is your plastic material suitable for pharmaceutical use?

As of May 2016, a revision in the U.S. Pharmacopeia’s monograph for <661> changes the requirements  for the testing of polymeric materials used for pharmaceutical packaging. The updated monograph has been divided into <661.1>, “Plastic Materials of Construction,” and <661.2> “Plastic Packaging Systems for Pharmaceutical Use.” In order that a plastic material be considered suitable for pharmaceutical use, it should be thoroughly characterized.  While not all polymers are cited specifically in the monograph, those that are most commonly used in the pharmaceutical industry for packaging systems. Plastic materials of construction not included in this list must be characterized with the same intent. The evaluation of a polymer material of construction, according to USP <661.1> is extensive, and includes identification, physico-chemical testing, biological reactivity, additives analysis, and extractable metals.

Plastic Packaging Systems include any container, whether it is bag, bottle, syringe, or inhaler, which comes into direct or indirect contact with the drug product. Evaluation of a plastic packaging system according to USP <661.2> includes biological reactivity, and physicochemical testing. A chemical safety assessment of the plastic packaging system should also be considered, and this could be accomplished through extractables and leachables testing.

Impact Analytical has the expertise and experience to evaluate your polymer material and container in compliance with USP <661>. From extraction, to analysis, to data evaluation, you can have confidence that your study will meet with USP and cGMP quality standards.

Impact Analytical is uniquely suited to perform the polymer characterization and quantitative additive analysis required to demonstrate that the raw materials are compliant with <661.1> and  to ensure that the systems and packaged products that are formed from these materials meet the requirements of <661.2>.

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