© Pharmeuropa | Useful information | September 2015
Updated work programme
of the European Pharmacopoeia
(June 2015)
The following items have been added to or deleted from the work programme during
the 152nd session of the European Pharmacopoeia Commission. The complete work
programme is available in the Knowledge Database.
Interested parties are invited to contact the EDQM via the HelpDesk with a view to
participating in the work on items of interest.
TEXTS TO BE REVISED
General notices
1. General notices
Definition of the term “freshly prepared”
Methods of analysis
2.2.29. Liquid chromatography
Inclusion of MALS
2.2.30. Size-exclusion chromatography
Inclusion of MALS
2.3.2. Identification of fatty oils by thin-layer
chromatography
Inclusion of chromatogram of hydrogenated
arachis oil (Figure 2.3.2-1)
2.9.6. Uniformity of content of single-dose
preparations
Alignment of requirements with the revised
monographs 1239 and 1164
2.9.19. Particulate contamination: sub-visible particles
Revision to address particulate contamination of
biological products
Materials and Containers
3.2.1. Glass containers for pharmaceutical use
Hydrolytic resistance: clarify description of sample
preparation process
Dosage forms
Granules (0499)
Inclusion of small tablets presented in sachets
Vaginal preparations (1164)
Revision to include vaginal delivery systems (and
sub-section)
Radiopharmaceutical preparations
Ammonia (13N) injection (1492)
Replacement of half-life determination by
approximate half-life determination
Carbon monoxide (15O) (1607)
Replacement of half-life determination by
approximate half-life determination
Copper tetramibi tetrafluoroborate for
radiopharmaceutical preparations (2547)
Revision of limits for BET test (2.6.14)
Flumazenil (N-[11C]methyl) injection (1917)
Replacement of half-life determination by
approximate half-life determination
Fluorocholine (18F) injection (2793)
Chemical purity test
Iobenguane sulfate for radiopharmaceutical
preparations (2351)
Revision of limits for BET test (2.6.14)
Medronic acid for radiopharmaceutical preparations
(2350)
Revision of limits for BET test (2.6.14)
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© Pharmeuropa | Useful information | September 2015
Raclopride ([11C]methoxy) injection (1924)
Replacement of half-life determination by
approximate half-life determination
Sodium acetate ([1-11C]) injection (1920)
Replacement of half-life determination by
approximate half-life determination
Sodium fluoride (18F) injection (2100)
Replacement of half-life determination by
approximate half-life determination
Sodium iodohippurate dihydrate for
radiopharmaceutical preparations (2352)
Revision of limits for BET test (2.6.14)
Tetra-O-acetyl-mannose triflate for
radiopharmaceutical preparations (2294)
Revision of limits for BET test (2.6.14)
Water (15O) injection (1582)
Replacement of half-life determination by
approximate half-life determination
Herbal drugs
Yarrow (1382)
Request for revision: binominal name and content
requirements
Homoeopathic preparations
Homoeopathic preparations (1038)
Revision following inclusion of Homoeopathic
pillules, coated monograph (2786)
Pillules for homoeopathic preparations (2153)
Revision following inclusion of Homoeopathic
pillules, coated monograph (2786)
Monographs
Alfacalcidol (1286)
Related substances test: new UPLC method
Ammonio methacrylate copolymer (type A) (2081)
Revision of the Assay titration method
Ammonio methacrylate copolymer (type B) (2082)
Revision of the Assay titration method
Amorolfine hydrochloride (2756)
Revision of related substances test to control
additional impurities
Arachis oil, hydrogenated (1171)
Revision of the Identification section (inclusion of
GC)
Arachis oil, refined (0263)
Revision of the Identification section (inclusion of
GC)
Basic butylated methacrylate copolymer (1975)
Revision of the Definition (average molecular
mass)
Ergocalciferol (0082)
Related substances test
Ethanol (96 per cent) (1317)
Revision of the test for volatile impurities
Ethanol, anhydrous (1318)
Revision of the test for volatile impurities
Ifosfamide (1529)
Revision of related substances test to replace TLC
methods and to introduce an additional impurity
Mycophenolate sodium (2813)
Revision of the related substances test to allow
control of the Z-isomer and some other impurities
Nitrofurantoin (0101)
Revision of the Identification section
Olive oil, refined (1456)
Revision of the Identification section (inclusion of
GC)
Olive oil, virgin (0518)
Revision of the Identification section (inclusion of
GC)
Permethrin (25:75) (1762)
Replacement of current GC (related substances)
and LC (assay) method by a new LC method
Ranitidine hydrochloride (0946)
Related substances: update of impurity
specifications
Sodium cetostearyl sulfate (0847)
Revision of the water test (sample size)
Soya-bean oil, refined (1473)
Revision of the Identification section (inclusion of
GC)
© Pharmeuropa | Useful information | September 2015
Tartaric acid (0460)
Addition of a test for related substances (synthetic
origin)
Terazosin hydrochloride dehydrate (2021)
Revision of related substances for the addition of
a new impurity
Tilidine hydrochloride hemihydrate (1767)
Revision of related substances for the addition of
a new impurity
Tyrothricin (1662)
Revision of limits for the test for composition
NEW TEXTS TO BE ELABORATED
Monographs
Amprolium hydrochloride for veterinary use (3010)
Phytomenadione, racemic (3011)
Silver sulfate (3013)
DELETIONS FROM THE WORK PROGRAMME
(new texts or requests for revision)
Gallium (68Ga) chloride solution for radiolabelling (2464)
Gallium (68Ga) edotreotide injection (2482)
Pancreas powder (0350)
Pinellia rhizome (2654)
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