Compendial Tools are documents, spreadsheets, databases, photographs, and other items that are intended to aid the user in the application of USP standards. These tools are not official, and do not affect the interpretation of the USP, NF, FCC, or any other USP-developed compendium. These tools are not intended to be used to determine that an article does or does not comply with compendial requirements, are not sufficient for that purpose, and should not be used in that manner. These tools are used at the user's own discretion and risk.
The following Compendial Tools currently are available:
USP Dissolution Methods Database
This searchable database contains the test conditions (except Tolerances or Acceptance Criteria) as stated in the sections referring to dissolution, disintegration or drug release tests in the respective USP drug product monograph.
Calculation Tool for the Performance Verification Test (PVT) of Dissolution Assemblies
This calculation tool allows the evaluation of the performance of a dissolution assembly by comparing the results obtained from the PVT to limits given in the Acceptance Criteria for PVT Tablets.
This toolkit provides procedures that help manufacturers and others to evaluate the correct set-up, operation, and performance of the basket and paddle apparatuses and the test assembly.
An interactive tool that allows to find possible alternative HPLC columns to the column used to develop and validate a chromatographic procedure.
USP Four Parameter Logistic (4PL) Bioassay Simulator
The purpose of the simulator is to provide an easily-navigated, interactive medium in a familiar environment that illustrates many of the 4PL data analysis concepts and recommendations in the new suite of bioassay chapters, particularly <1034> Analysis of Biological Assays. It is also intended as a learning environment for scientists or statisticians who need to become more familiar with 4PL bioassay data analysis.