Kathy Heatherly, MSFS, ARL Associate Chemistry Supervisor A bulk substance, or active pharmaceutical ingredient (API), is often the starting point of a compounded preparation. Compounding

Sterility and Endotoxin Kayla Lipcaman, ARL Bio Pharma Associate Microbiology Supervisor Two critical tests for sterile compounded preparations are Sterility and Endotoxin testing. USP 797

Product & Service Providers in: COMPOUNDING: USP <797> & <800> Sterile Resouces, Compliance, Technology SOFTWARE: Drug Diversion Monitoring, Diversion Prevention As Seen In: View ARL

Bracketing and Its Application to Quality Testing Bracketing is a testing design approach recognized by USP, FDA, and ICH for assessing the quality of pharmaceutical

USP 797 has minimum standards that are the framework of sterile compounding. However, many facets of sterile compounding are not covered in 797 or are

What is stability? The extent to which a product or preparation retains physical and chemical properties and characteristics within specified limits throughout its expiration or

Nicole Vu, PhD, Scientific Director, ARL Bio Pharma Compounding with synthetic peptides Therapeutic peptides are biosimilar molecules, composed of a-amino acid (AA) polymer with a

The United States Pharmacopeia requires each facility to have a designated person for chapters 795, 797, 800, and 825. This role is vital to maintaining