Pharmaceutical Societies

USP: United States Pharmacopoeia: provides a framework on test methods, specifications and general information for pharmaceutical products.

BP: British Pharmacopoeia: provides a standard for UK pharmaceutical research.

EP: European Pharmacopoeia: provides a standard for European pharmaceutical research.

JP: Japanese Pharmacopoeia: provides a standard for Japanese pharmaceutical research.

Agencies

EPA: Environmental Protection Agency

Tests and Practices

USP Purified Water: passes the USP monograph test for purified water.

Current Good Manufacturing Practices (cGMP): FDA’s regulations on the maintenance of manufacturing processes and facilities.

Master Batch Record: description of the pharmaceutical manufacturing process.

OTC Drug Monograph Process: evaluates the safety and effectiveness of OTC drug products marketed in the United States.

Cylinder-Plate Assay: a method of antibiotic potency testing that extracts the antibiotic active ingredient(s) from the product being tested using solvents and phosphate buffers as outlined in USP <81>.

Endotoxin Testing: an in-vitro assay used for the detection and quantitation of bacterial endotoxins in injectable products or implantable medical devices.

Low-Level Detection: the highly-sensitive type of testing that is utilized for analytes, which may be present in a material at a low-level.

1,4 Dioxane: a synthetic industrial chemical that, historically, has been used as a solvent in the synthesis of many types of industrial chemicals.