Monday, 7 April 2014

2nd update to European Pharmacopeia 8th edition (8.2)


Supplement 8.2 to the Ph. Eur. has been issued.

Implementation date 1st July 2014

The main changes are:

2.2.32  Loss on drying            
                                                           
The user’s attention is drawn to the possibility of using a suitable certified reference material for instrument performance verification.

2.5.12  Water: semi-micro determination       
                                               
The user’s attention is drawn to the possibility of using a suitable certified reference material for instrument performance verification.

2.6.21  Nucleic acid amplification techniques
                                   
The chapter has been updated to take account of closed systems for nucleic acid amplification. Additional minor editorial changes have been made throughout the text, including updating the ICH guideline reference, removing an incorrect WHO HCV reference and removing the detail on operator qualification, which is part of GMP.

2.7.4    Assay of human coagulation factor VIII
                                               
Chapter revised to cover quantification of factor VIII activity in plasma preparations and in therapeutic concentrates, to refer to the International Standard for coagulation factor VIII in plasma and to add coagulation factors V, VIII, XI and XIII plasma BRP.

2.7.22  Assay of human coagulation factor XI
                                               
Chapter revised to include coagulation factors V, VIII, XI and XIII plasma BRP and to refer to the International Standard for coagulation factor XI in plasma.

Alanine (0752)
                                                                                               
Identification: sample preparation for IR deleted in accordance with current policy.
Ninhydrin-positive substances: TLC replaced by chromatography using an amino acids analyser that also allows quantification of ammonium; TLC kept for identification.
Assay: end-point determination by colour indicator replaced by potentiometry.
Impurities: section added.
Arginine hydrochloride (0805)
                                                           
Definition: scope of monograph added.

Identification: sample preparation for IR deleted in accordance with current policy. Ninhydrin-positive substances: TLC replaced by chromatography using an amino acids analyser that also allows quantification of ammonium; TLC kept for identification.

Assay: end-point determination by colour indicator replaced by potentiometry.

Impurities: section added.

Posted by Tim Sandle