PDG Meeting at EDQM in Late May

[membership level=”0,4″][The content continues for paid members only.] Login or Subscribe [/membership][membership level=”1,5,6,7,8,9,10,11,12″][membership] The Pharmacopoeial Discussion Group (PDG) reported after its meeting in late May at EDQM headquarters in Strasbourg, France that 29 of 36 General Chapters and 49 of 67 excipient monographs on its current work program have been harmonized between the US, Japanese, and European pharmacopeias. Updates are provided in the report on the remaining topics. Sign-offs at the meeting included a new monograph on hydroxyethylcellulose and two revised monographs – on ethylcellulose and cellulose acetate. Efforts continued on new chapters on chromatography, which is nearing the Stage 4 public comment phase, and on elemental impurities, intended to facilitate ICH Q3D implementation. Five new excipient monographs were added to the work list: isostearyl alcohol, myristyl myristate, polysorbate 65, sodium cetyl sulfate and calcium silicate. These will represent the first excipient monographs developed within the PDG using a prospective approach. The PDG met with the IPEC Federation on the second day to discuss key excipient monograph topics.
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