A mass-balance approach is commonly used to establish
the potency of an active pharmaceutical ingredient (API) reference
standard by subtracting non-API components from 100%
Mass balance – the practical application of the Law of Conservation
of Mass to chemical synthesis and degradation – is a concept
that is used throughout the pharmaceutical industry. During synthetic
route development, mass-balance calculations are used to
assess yields and efficiency of chemical transformations. In pharmaceutical
development, mass-balance assessments indicate
material losses that are typical of any multi-step manufacturing
process