Determination of Melting Points
According to Pharmacopeia
Application Note #4
The development and manufacturing of pure chemicals requires that close
attention be paid to purity, quality, stability and safety to ensure that the final
product performs as intended.
One of the analytical techniques applied to the characterization of pure
chemicals and pharmaceutical drugs (from raw material, to scale-up, to
finished form) is the melting point (MP) determination. Carefully choosing the
MP determination procedure is important for generating certifiable results for
chemical quality control (QC) and quality assurance (QA).
In addition to following well-defined guidelines for Good Laboratory Practice
(GLP) and Good Manufacturing Practice (GMP), pharmaceutical QC/QA labs
must also follow multiple strict chemical analysis protocols set forth by local,
national and even international Pharmacopeias.
Analytical QC/QA laboratories m|