FPGEE for National Association of Boards of Pharmacy (NABP) Practice Exam

The term “pyrogen testing” is most closely related to endotoxin testing in the context of sterile preparations. Pyrogens are fever-inducing substances that can come from various sources, but the primary concern in sterile preparations is bacterial endotoxins, which are components of the outer membrane of Gram-negative bacteria. When injected into the body, these endotoxins can trigger a significant immune response, including fever.

Endotoxin testing is performed to ensure that any sterile product, such as injectable medications, is free from pyrogenic contaminants. The Limulus Amebocyte Lysate (LAL) test is one of the most common methods used to detect endotoxins. This testing is crucial to protect patients and ensure the safety and efficacy of sterile products.

The other options, while relevant to the pharmaceutical context, do not directly relate to pyrogen testing. For example, examination of color changes might pertain to visual inspections of preparations, compatibility assessments deal with the interaction between different medications or solutions, and stability testing refers to evaluating the shelf life and integrity of a product under various conditions. However, none of these options specifically address the need to test for endotoxins, which is the principal concern of pyrogen testing.