Controls For Photometric Tests: Implications For Low Capacity Test Systems

Instrumentation for photometric endotoxin tests must have a capacity for at least 12 samples in order to meet the requirements of the pharmacopeial endotoxins test chapters. Small test systems with a low capacity, including those that rely on archived curves, cannot accommodate the controls specified in the pharmacopeia or guidance documents.

Introduction
The minimum sample numbers for photometric test systems are described in this article. These are dictated by the requirements for specific controls given in the bacterial endotoxins test (BET) chapters in the United States, European and Japanese pharmacopeia and by the recommendations made in United States Food and Drug Administration's (FDA) guidance documents.