USP’s Pharmaceutical Analytical Impurities (PAI) product line has hit a major milestone. The PAI portfolio now has over 400 impurity analytical reference materials covering 75 Active Pharmaceutical Ingredients (APIs) across over 15 therapeutic categories. PAI products include impurities listed in USP monographs but not available as USP Reference Standards as well as critical degradants and process impurities.

Finding dependable and trust-worthy suppliers of impurity reference materials can be a major hurdle for any drug developer or manufacturer. The unavailability of quality impurity materials can dramatically hinder your ability to develop robust analytical methods, leading to increased costs and time delays along with increased risk of product release or approval failure.

Drug developers and manufacturers have long relied on USP for pharmacopeial Reference Standards needed to meet regulatory expectations. As a leading provider of official Reference Standards trusted by thousands of manufacturers and regulators around the world, USP offers PAI analytical reference materials to support your impurity-related needs.*

APIs covered include Duloxetine, Epinephrine, Pregabalin, Amiodarone, Clavulanate Potassium, Azacitidine, Azithromycin, Cobicistat, Ethinyl Estradiol, Rosuvastatin Calcium, Tobramycin, and many more.

Therapeutic categories covered include cardiovascular, oncology, antibiotics, antivirals, antipsychotics, corticosteroids, and more.

Labmix24 is an authorized distributor for the US Pharmacopeia. Learn more about USP PAIs here: https://labmix24.com/en/pharmaceutical-reference-standards/us-pharmacopeia/analytical-impurities

*PAI products are different from official USP Reference Standards. PAI products are not required for compendial compliance.