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USP <797> states compounders must ensure products maintain labeled strength within monograph limits. The difficulty with determining limits (specifications) for compounded preparations is that there may not be a monograph to reference. In these cases, ARL assigns the specification by choosing them from a monograph that is closest to the product being tested.

For potency testing with respect to HPLC, IC and/or GC methodologies, ARL verifies by way of system suitability that we are capable of performing the analysis.

Now is the time to prepare for proposed changes to USP <797>.

Over the next few newsletters, we will highlight proposed changes to sterile compounding testing requirements and how ARL can help your pharmacy meet USP standards.

We begin with Personnel Qualification and Environmental Monitoring Requirements for Compounded Sterile Preparations (CSPs) Categories 1 and 2.

The sampling quantities defined in USP <71> Sterility Tests are determined based upon statistical probabilities of identifying contamination, should it be present, given various article and batch sizes. The specific direction to follow is found in tables 2 and 3 in the chapter. Table 2 defines the minimum volume per test article to be inoculated into each sterility media type.

Mycoplasmas are a fascinating group of extremely small bacteria with unique characteristics and growth habits. There are over 120 species of Mycoplasmas found in and on a variety of animal and plant hosts. They possess no cell walls, are fastidious in their growth requirements, and are the smallest type of self-replicating prokaryotic organism.

In 2022, Compounding Today ran a series of articles on pharmaceutical compounding errors. These articles are captured in an 11 part series. See the links below for access to content.