What is the Origin of USP 85?

This term is a reference to the organizational standard-setting body, the USP, and the numerical designation of the general chapter, 85. The requirement for endotoxin testing arose from historical cases of patient harm caused by pyrogens in injectable solutions, leading to the development of this rigorous quality standard.

What is the Mechanism of USP 85?

The test mechanism, often the Limulus Amebocyte Lysate (LAL) assay, involves mixing a sample of the hormonal preparation with a lysate derived from the blood of the horseshoe crab. If bacterial endotoxins are present, they trigger a cascade of reactions in the lysate, resulting in coagulation or a measurable color change. This sensitive biological reaction provides a reliable, quantifiable method to confirm the absence of dangerous pyrogenic contamination in sterile injectable products.

USP 85 ∞ Area

USP 85

Meaning

A specific general chapter within the United States Pharmacopeia (USP) that outlines the standardized procedure for conducting bacterial endotoxins testing (BET) on pharmaceutical products and medical devices. This testing is a critical quality control measure to ensure that injectable drugs, including hormonal preparations, are free from pyrogenic bacterial toxins. Adherence to USP 85 is mandatory for compounded and manufactured sterile products to ensure patient safety.