Tuesday, 1 December 2015

European Pharmacopoeia 8.7

Review of Supplement 8.7: Implementation date 1st April 2016. Items of interest are copied below.

General Chapters

2.2.31  Electrophoresis                                                                       

This chapter has been revised to take recent developments and current practice into account.
The scope of the chapter has been modified, with the introduction of a new section on gradient concentration gels for SDS-PAGE. For uniform percentage gels, a reference has been added to tricine-SDS gels for the detection of proteins and peptides with a smaller mass range. In addition, further flexibility with regard to stains has been introduced, and indications for storage of reagents added. The section dealing with gel drying has been renamed and now also refers to scanning of wet gels. For molecular mass calculation, non-linear regression is now mentioned as an alternative to linear regression. General aspects to be covered in the validation have also been added.

2.6.15  Prekallikrein activator                                                

Additional clarification provided on spiking experiments and high blank values.


Human coagulation factor XI (1644)                        

C1-esterase inhibitor: this monograph has been modified due to the creation of a new general chapter 2.7.34. Assay of human C1-esterase inhibitor, which describes a slightly modified method for the assay deleted from this monograph.

Sorbitol (0435)                                                                       

Related substances: chromatographic run time modified; information about detector temperature added; minimum resolution requirement given with more accuracy.

Water: mixture of solvents used for sample dissolution indicated.

Posted by Tim Sandle