Details of the tenth edition of the European Pharmacopeia have been published. The European Pharmacopoeia (Ph. Eur.) is a single reference work for the quality control of medicines. The official standards published within provide a scientific basis for quality control during the entire life cycle of a product.
The general chapters being updated are:
2.2.25. Absorption spectrophotometry, ultraviolet and visible
2.6.33. Residual pertussis toxin
2.7.2. Microbiological assay of antibiotics
2.7.23. NumerationofCD34/CD45+cellsinhaematopoietic products
2.7.35. Immunonephelometry for vaccine component assay
2.8.25. High-performance thin-layer chromatography of herbal drugs and herbal drug preparations
2.9.1. Disintegration of tablets and capsules
2.9.20. Particulate contamination visible particles
3.1.13. Plastic additives
3.3.1. Materials for containers for human Blood and blood components
3.3.2. Materials based on plasticised poly(vinyl chloride) for containers for human blood and blood components
3.3.3. Materials based on plasticised poly(vinyl chloride) for tubing used insets for the transfusion of blood and blood components
3.3.4. Sterile plastic containers for human blood and blood components
3.3.5. Empty sterile containers of plasticised poly(vinyl chloride) for human blood and blood components
3.3.6. Sterile containers of plasticised poly(vinyl chloride) for human blood containing anticoagulant solution
3.3.7. Sets for the transfusion of blood and blood components
3.3.8. Sterile single-use plastic syringes
The 10thedition of the Pharmacopoeia will contain 114 new and 683 revised texts, approximately 30% of the content is new or revised compared to Edition 9.0.
It contains 2 420 monographs, 374 general texts (including general monographs and methods of analysis) and around 2 780 descriptions of reagents.
Posted by Dr. Tim Sandle, Pharmaceutical Microbiology