Pharmacopoeia 2.2.5 - European
The chapter outlines several primary techniques for this measurement:
Failure to follow the specified temperature or apparatus type can lead to regulatory observations (e.g., FDA 483, EU GMP non-compliance). european pharmacopoeia 2.2.5
It is useful to compare Ph. Eur. 2.2.5 with similar chapters: The chapter outlines several primary techniques for this
Before delving into the method, it is vital to understand why regulatory authorities demand this test. european pharmacopoeia 2.2.5