Wednesday, 15 January 2014

European Pharmacopoeia 8th Edition

The 8th edition of the European Pharmacopeia had an implementation date 1st Jan 2014. The monographs and general chapters that are new, or that have been revised, corrected or deleted for the 8th Edition are:

2.2.40  Near-infrared spectroscopy                                                                

General revision to introduce process analytical technology (PAT) concepts such as in- and on-line measurements. Furthermore, duplication with EMA text “Guideline on the use of Near Infrared Spectroscopy (NIRS) by the pharmaceutical industry and the data requirements for new submissions and variations” (under revision) has been avoided.

3.2.9.   Rubber closures for containers for aqueous parenteral preparations, for powders and freeze-dried powders                                                 
  • Identification A: requirement for elasticity deleted since test cannot be performed on all types of rubber closures; identifications B and C renamed A and B respectively.
  • Identification B: possibility of recording FTIR-ATR spectra directly on surface of sample introduced.
  • Identification C: limit adapted and now depends on total ash content of type sample.
  • Solution S: water for injections R replaced with water R; use of another container for preparation of solution S added.
  • Volatile sulfides: description of preparation of standard solution revised.

Human plasma for fractionation (0853)                                             

Individual plasma units: questions have arisen amongst some users of the monograph over the reference to freezing plasma intended for the production of non-labile proteins ‘as soon as possible’ after collection. This is because time limits of 24 h (plasma obtained from plasmapheresis) and 72 h (plasma obtained from whole blood) are also given for freezing. For clarification, the reference to ‘as soon as possible’ has been deleted and the monograph now states the maximum acceptable time limits for freezing of plasma following collection. Additionally, in the context of using suitable methods to conserve labile proteins as much as possible, the reference to good manufacturing practice (GMP) has been deleted because there are steps taken that do not necessarily fall under the scope of GMP which contribute to the quality of plasma and the conservation of labile proteins.

2.4.13  Sulfates

Insertion of text: ‘the prescribed’ solution.

Human Albumin solution (0255)

Correction:  ‘preparation’ to ‘test solution’.

Posted by Tim Sandle