Chemical Lab

Our scientists provide regulatory compliance testing to a diverse range of clients. Accuon Labs provides the analytical services to pharmaceuticals, Nutraceuticals, cosmetic, food & beverages manufacturers by analyzing raw materials to finished product. Our facility performs testing based on the stringent regulations set forth by both CGMP and FDA in order to provide the most accurate and precise results available. Clients can be assured their products will meet the strict quality requirements set forth by regulatory agencies.

Genotoxic Impurities

Genotoxic impurities (GTIs) belong to a class of compounds that interact with DNA and induce genetic mutations. These compounds add significant risk without adding any benefit to patients and are also known as mutagenic impurities. Therefore, exposure to even low levels of such impurities may be of significant toxicological concern.

Microbiology Lab

FDA Guidance on Microbiological Quality Considerations
in Non-Sterile Drug Manufacturing

This guidance is intended to assist manufacturers in assuring the control of microbiological quality of their non-sterile drugs (NSDs). The recommendations herein apply to solid non-sterile dosage forms, as well as semi-solid, and liquid non-sterile dosage forms (e.g., topically applied creams, lotions and swabs, and oral solutions and suspensions). NSDs can be prescription or nonprescription drugs, including those marketed under approved new drug applications (NDAs) or abbreviated new drug applications (ANDAs), and nonprescription drugs without approved new drug applications which are governed by the provisions of section 505G of the FD&C Act (often referred to as over-the-counter (OTC) monograph drugs). These recommendations, if followed, will also assist manufacturers in complying with the current good manufacturing practice (CGMP) requirements for finished pharmaceuticals and active pharmaceutical ingredients (APIs).

Request a Quote