Proteins Reference Standards
Documentary standards
For associated documentary standards, please visit USP-NF Online (note: you will need a log-in to access specific standards)
Free Official General Chapter Downloads
- <124> Erythropoietin Bioassays
- <129> Analytical Procedures for Recombinant Therapeutic Monoclonal Antibodies
- <210> Monosaccharide Analysis
- <212> Oligosaccharide Analysis
- <1132> Residual Host Cell Protein Measurement in Biopharmaceuticals
- <507> Protein Determination Procedures
- <509> Residual DNA Testing
Related scientific publications
- The BioPhorum and USP collaborative journey to new standards (BioPhorum)
- Implementation of USP antibody standard for system suitability in capillary electrophoresis sodium dodecyl sulfate (CE-SDS) for release and stability methods
- Separation of 15 Underivatized Saccharide and Sialic Acid USP Standards
Expert committees
Our work is guided by scientific experts from a variety of disciplines and industries in the BIO3 Complex Biologics Expert Committee and associated expert panels. Find out what the BIO3 expert committee is up to by reviewing its work plan.
USP Education
USP Education provides year-round courses and programs on how to effectively interpret and apply USP’s internationally recognized quality standards.
Standards development process
We are developing standards that are broadly applicable across biological products, and delivering solutions to address the quality of raw materials as well as the development of performance standards which support analytical testing throughout the product lifecycle.