The author reviews the types of reference-standard materials used in drug-product manufacturing, discusses current regulatory requirements, and outlines a reference-standard qualification program. The ...

An AIST research team has developed a certified reference material (CRM) with a single degree of polymerization without distribution of molecular weight, even though it is an artificially manufactured ...

There are apparent inconsistencies between the use of these reference materials and the manufacture of the reference solutions that are actually used in the regulated test method. The monographs ...

NIST has released its first-ever reference material for peptide mass and concentration analysis. The reference material (NIST RM 8327) will help in protein analysis for disease diagnosis and drug ...