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Escherichia coli

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Escherichia coli (USP/EP)

Pharmaceutical Products (USP <62>)

Escherichia coli — Specified Microorganism (USP <62>)

Escherichia coli is a Gram‑negative bacterium used as a critical indicator of contamination and manufacturing hygiene. Under USP <62>, E. coli is classified as a specified (objectionable) microorganism and must be absent from applicable non‑sterile pharmaceutical products.

Testing for E. coli is performed using selective enrichment and differential culture methods designed to detect low‑level contamination in finished products, raw materials, and excipients. Demonstration of absence supports compliance with USP requirements, global pharmacopeial standards, and current Good Manufacturing Practices (cGMP).

Dietary Supplements & Nutritional Products (USP <2022>)

Escherichia coli — USP <2022> Absence Requirement

Under USP <2022>, Escherichia coli is a specified microorganism that must be absent from dietary supplements and nutritional products. Its detection may indicate unsanitary handling, contaminated raw materials, or ineffective process controls.

USP <2022> methods use enrichment and selective culturing techniques to determine the presence or absence of E. coli in defined sample quantities. Compliance with this chapter supports consumer safety, regulatory expectations, and validated Good Manufacturing Practices (GMP).