News & events

In June, we discussed Personnel Qualification and Environmental Monitoring Requirements for Compounded Sterile Preparations (CSPs) for Categories 1 and 2. This month we will discuss Category 3.

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.