Sunday, 31 January 2016

Pharmeuropa - Useful information

EDQM has published a document outlining useful updates edition 8.8 of the European Pharmacopeia.

Areas of change include:

2.2.3. Potentiometric determination of pH
2.2.46. Chromatographic separation techniques
2.4.22. Composition of fatty acids by gas chromatography
2.4.32. Total cholesterol in oils rich in omega-3 acids
2.6.8. Pyrogens

·         The text has been revised to include a reference to general chapter 2.6.30. Monocyte activation test as a potential replacement of the test for pyrogens, therefore avoiding the use of live animals.

5.1.10. Guidelines for using the test for bacterial endotoxins

·         A section has been added (section 2-4) to include aspects to be considered when establishing an endotoxin limit for a specific substance or product; also, the text has been revised to reflect the fact that an endotoxin limit is not always provided in a specific monograph.
·         Reference is made to general chapter 2.6.30. Monocyte-activation test as an alternative to the rabbit pyrogen test.
·         Reference is made to the use of alternative reagents to the Limulus amoebocyte lysate, such as recombinant factor C.
·         Method A is no longer declared as the reference method, and all methods A to F of general chapter 2.6.14. Bacterial endotoxins can be used.
·         The expression ‘threshold endotoxin concentration’ has been replaced by the more appropriate expression ‘endotoxin limit concentration’ to harmonise with general chapter 2.6.30. Monocyte-activation test.
·         A new entry has been included in Table 5.1.10.-1 for formulations administered per square metre of body surface.

5.3. Statistical analysis of results of biological assays and tests

5.4. Residual solvents

Radiopharmaceutical preparations (0125)

Substances for pharmaceutical use (2034)

Posted by Dr. Tim Sandle