: Mandatory for tablets where the active substance is less than 2 mg or represents less than 2% of the total mass, unless otherwise justified.
Many QC labs think hardness (crushing strength) is a key parameter. for routine release. However, it uses friability and dissolution as indirect controls. If you rely only on hardness and ignore friability, you will fail. european pharmacopoeia ph eur monograph tablets 0478 better
: There has been increased scrutiny on tablet divisibility, with studies showing many marketed tablets struggle to meet the strict Ph. Eur. mass uniformity requirements for subdivided parts. Harmonisation : Ongoing efforts by the Pharmacopoeial Discussion Group (PDG) : Mandatory for tablets where the active substance
: Tablets are solid preparations containing one or more active substances, usually obtained by compressing uniform volumes of particles. european pharmacopoeia ph eur monograph tablets 0478 better