When tested according to strict USP monograph guidelines, the product's pyrogenic material is less than the minimum Limit of Detection (LOD).

The United States Pharmacopeia-National Formulary (USP-NF) sets FDA-enforceable standards for medicines, dosage forms, drug substances, excipients, biologics, compounded preparations, medical devices, dietary supplements and other therapeutics.

Adherence to Current Good Manufacturing Practice (CGMP) assures consistent identity, strength, quality and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations through proper monitoring and design.

Registration with the U.S. Food & Drug Administration (FDA) submits a facility to routine inspection by an expert evaluator and timely investigation of any reported issues with manufactured products.

An official Certificate of Analysis provides supplier information, material identification, transportation data, evidence of conformance and a signature attesting that it follows all guidelines set forth the by the FDA.

All chitosan products are derived from shrimp grown with in our captive, controlled indoor shrimp production facilities and can be traced completely from start to finish.

trū Chitosan is the only producer of chitosan grown, harvested, synthesized and produced entirely within the United States.