Følgende generelle metoder er opptatt i Ph. Eur. pr. 1. juli 2021 

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Kapittel Navn 
21800 Methods of pretreatment for preparing traditional Chinese drugs general information 
20433 Tetrabutylammonium in radiopharmaceutical preparations 

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Kapittel Navn 
20904 Dissolution test for patches 
20627 Microbiological examination of cell-based preparations 
52200 Names of herbal drugs used in traditional Chinese medicine 

Følgende generelle metoder var opptatt i Ph. Eur. pr. 1. april 2021

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5.28Multivariate statistical process control

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2.5.29.Sulfur dioxide
4.Reagents (new, revised, corrected)
5.22.Names of herbal drugs used in traditional Chines medicines
5.25.Process analytical technology

Følgende generelle metoder var opptatt i Ph. Eur. pr. 1. januar 2021

Nye tekster

5.1.12.Depyrogenation of items used in the production of parenteral products
5.17.2.Recommendations on testing of particulate contamination: visible particles
2.6.32.Test for bacterial endotoxins using recombinant factor C

Reviderte tekster

2.2.2.Degree of coloration of liquids
2.2.24.Absorption spectrophotometry, infrared
2.2.29.Liquid chromatography
2.2.49.Falling ball and automatic rolling ball viscometer methods
2.6.12.Microbiological examination of non-sterile products: microbial enumeration tests
2.6.13.Microbiological examination of non-sterile products: test for specified micro-organisms
2.6.27.Microbiological examination of cell-based preparations
2.7.14.Assay of hepatitis A vaccine
2.9.19.Particulate contamination: sub-visible particles
3.3.4.Sterile plastic containers for human blood and blood components
3.3.8.Sterile single-use plastic syringes
4.Reagents (new, revised, corrected)
5.1.4.Microbiological quality of non-sterile pharmaceutical preparations and substances for pharmaceutical use
5.1.5.Application of the F concepts to heat sterilisation processes
5.1.10.Guidelines for using the test for bacterial endotoxins
5.22.Names of herbal drugs used in traditional Chinese medicine

Publisert: 01.07.2021

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