Pharmacopeias Continue Harmonization Program

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The Pharmacopoeial Discussion Group approved monographs and plans to harmonize several others.

On June 21, 2016, the European Directorate for the Quality of Medicines & HealthCare (EDQM) released

from the May 25–26, 2016 meeting of the Pharmacopoeial Discussion Group (PDG). The PDG signed off on one new monograph, Hydroxyethylcellulose, and two revised monographs, Ethylcellulose and Cellulose acetate.

The PDG, which includes the European Pharmacopoeia(EP), the Japanese Pharmacopoeia (JP), and the United States Pharmacopeia, discussed a number of outstanding issues and continues to focus its efforts on the elaboration of chapters related to chromatography and elemental impurities. The PDG aims to present a stage four draft of the new “Chromatography” chapter for public comment in the “near future.” The group exchanged information on their approaches to implementing the ICH guideline on elemental impurities and intends to continue harmonizing the chapter on testing procedures.


Harmonization of several other topics includes the following:

  • Metal impurities. The stage three text is to be revised based on a teleconference held in February 2016.

  • Inhalation. A teleconference will be held to discuss mass balance, interstage drug losses, and fine particle dose.

  • Peptide mapping. The EP and JP will review the revised stage four draft.

  • Calcium phosphate dibasic anhydrous. The group decided to republish the monograph for public comment with revised assay limits.

  • Carmellose sodium. Some comments that have been received on the revised stage three draft still need to be addressed. The PDG is performing method development and validation on infrared identification.

Additional monographs discussed included lactose anhydrous/lactose monohydrate/lactose for inhalation, petrolatum, polyethylene glycol, polysorbate 80, silicon dioxide, stearic acid, talc, glycerin, and starch.

Five new items were also added to the PDG’s program: isostearyl alcohol, myristyl myristate, polysorbate 65, sodium cetyl sulfate, and calcium silicate. These additions increase the number of excipients to be revised to 67.