European Pharmacopoeia 9th Edition

A new edition of the European Pharmacopeia is effective from 1st Jan 2017. The following changes have been made:

Test for heavy metals have been deleted from the monographs concerned.

‘Anhydrous’ has been deleted from the title of the monographs concerned.

           

Monographs

As a first step of the Ph. Eur. strategy of implementation of the ICH Q3D guideline

for elemental impurities and according to the decision taken at the 151st session of the European Pharmacopoeia Commission (March 2015), the test for heavy metals (2.4.8 and equivalent) will be deleted from all individual monographs on substances for pharmaceutical use (except substances for veterinary use only). Impacted monographs are listed in the table below. These deletions will be implemented for the 9th Edition and will therefore come into force on 1 January 2017.

            Acetic Acid Glacial (0590)

            Alanine (0752)

            Arginine hydrochloride (0805)

            Calcium chloride dihydrate (0015)

            Caprylic acid (1401) - Octanoic acid

            Citric acid monohydrate (0456)

            Disodium edetate (0232)

            Disodium phosphate dihydrate (0602)

            Glycine (0614)

            Heparin sodium (0333)

            Hydrochloric acid, concentrated (0002)

            Lysine hydrochloride (0930)

            Octoxinol 10 (1553) – Triton X 100

            Polysorbate 20 (0426)

            Polysorbate 80 (0428)

            Sodium acetate trihydrate (0411)

            Sodium chloride (0193)

            Sodium citrate (0412)

            Sodium dihydrogen phosphate dihydrate (0194)

            Sodium hydrogen carbonate (0195)

Assay: use of the colour indicator has been replaced by a potentiometric end-point determination.

Sodium hydroxide (0677)

Trehalose dihydrate (2297)

Tri-n-butyl phosphate (1682)

Trometamol (1053)

Tryptophan (1272)

Corrected Texts

The following texts have been corrected. The corrections are to be taken into account not later than 31 Aug 16

2.2.27  Thin layer chromatography

Posted by Dr. Tim Sandle