Thursday, 8 October 2015

European Pharmacopoeia 8.6


Review of Supplement 8.6: Implementation date 1st Jan 2016. Items of interest are copied below.

Revised texts

2.2.20  Potentiometric titration                                                          

General method updated to introduce modern autotitrator instruments; reference to mercury- containing electrodes deleted following the entry into force of EU Regulation 847/2012 restricting the use of mercury in measuring devices

Monographs


Anticoagulant and preservative solutions for human blood (0209): Identification A: name of CRS modified to indicate degree of hydration; system suitability performed using reagents instead of CRSs (valid for ACD and CPD).

Lysine hydrochloride (0930): Ammonium: presented as a separate limit test from the test for ninhydrin-positive substances

Polysorbate 80 (0428): This monograph has been revised to indicate its status within the context of International Harmonisation, a collaboration between the Japanese Pharmacopoeia, the United States Pharmacopeia and the European Pharmacopoeia. A footnote has been included in the text to refer to chapter 5.8. Pharmacopoeial harmonisation

Sodium hydroxide (0677): Chlorides, Sulphates: limits increased.

Sucrose (0204): Identification B: system suitability performed using reagents instead of CRSs.



Posted by Tim Sandle