Complying with USP 661.1/661.2

Dec 6, 2018
By M.Turner

When will my containers need to comply with USP <661.1> and USP <661.2>?


The new versions of these monographs will come into force on the 1st of May 2020. Old and new packaging systems will need to comply from this date onward, having been assessed using tests that are up to date. The required information includes extractable and leachable based safety assessments, biological reactivity testing, and toxicological risk assessments.

One primary concern is the possibility of metal ions transferring into the formulation. As in previous versions of the methods, there is also a variety of analyses to compare the container materials to USP reference materials. These materials are cyclic olefins, polyethylene, polypropylene,

polyethylene terephthalate, and plasticized polyvinyl chloride. When other materials are employed, similar analysis is required along with evidence to demonstrate toxic materials are not transferred to a patient. This means full chemical analysis of extractables accompanied by a toxicological risk analysis, even though this is not specifically stated in the monograph.

Finally, there is a requirement for biological reactivity/cytotoxicity testing according to USP <87> and for more invasive formulations USP <88> class testing.

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