Revised Ph. Eur. Monographs on Excipients due to ICH Q3D

Several revised Ph. Eur. Monographs on excipients commonly used in semi-solid formulations (e.g. oils, fats, waxes, emulsifiers) have been proposed in Pharmeuropa 30.2. Deadline for comments is June 30, 2018.

In line with the Ph. Eur. implementation strategy for the ICH Q3D guideline on elemental impurities, the test on Nickel is proposed for deletion as the relevant elemental impurities are considered to originate from the production process. A change to this effect has been introduced in the Production section of the general Ph. Eur. monograph “Substances for pharmaceutical use” (with Ph. Eur. supplement 9.3), as only the manufacturer of a substance for pharmaceutical use knows which elemental impurities may be potentially introduced as catalysts and reagents, and whose levels would therefore need to be controlled.

This affects the following Ph. Eur. Monographs:

  • Hard fat
  • Hard fat with additives
  • Arachis oil, hydrogenated
  • Castor oil, hydrogenated 
  • Cottonseed oil, hydrogenated 
  • Glycerol dibehenate
  • Glycerol distearate
  • Glycerol monostearate 40-55
  • Macrogol 15 hydroxystearate
  • Macrogol 30 dipolyhydroxystearate
  • Palmitic acid
  • Stearic acid
  • Soya-bean oil, hydrogenated
  • Squalane
  • Triglycerides, medium-chain (additional removal of the tests for Chromium, Copper, Lead, Tin)

Furthermore, a draft for a new monograph on Cocoa butter has been published for comment  in the same issue of Pharmeuropa.

For more information plese see Pharmeuropa Online.

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