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USP <795> states that pharmacists performing non-sterile compounding must ensure that the finished preparation has its accepted potency, purity, quality, and characteristics. This article discusses the tests described in USP <61> and USP <62> that are used to determine if non-sterile products meet quality requirements.

Liothyronine Sodium (T3) and Levothyroxine Sodium (T4) are iodonated amino acids and are typically formulated in microgram concentrations. These active pharmaceutical ingredients (APIs) contain water: up to 4% in the T3 powder and up to 11% in the T4 powder. The primary reasons for the difficulty in preparing formulations containing T3 and/or T4 arise from these 3 issues: microgram concentrations, iodination of the compound, and water.

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.