© Pharmeuropa | Useful information | March 2016
Updated work programme
of the European Pharmacopoeia
(November 2015)
The following items have been added to or deleted from the work programme during
the 153rd 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
Methods of analysis
2.2.32. Loss on drying
Revision of the vacuum requirements and
alternatives to diphosphorus pentoxide
2.6.33. Residual pertussis toxin and irreversibility of
pertussis toxoid
New, validated in vitro assay proposed as
Method A and in vivo assay as Method B, as an
outcome of collaborative study BSP114
2.8.13. Pesticide residues
Review of the limit for pendimethalin
2.9.19. Particulate contamination: sub-visible particles
Revision for PDG harmonisation
2.9.20. Particulate contamination: visible particles
Revision of test requirements
General texts
5.2.5. Substances of animal origin for the production
of immunological veterinary medicinal products
Revision of extraneous agents testing: scope
extension to include risk management and to
include all the material of animal origin used
for the production of IVMPs (cell cultures,
embryonated eggs, bacterial and viral seed lots)
General monographs
Substances for pharmaceutical use (2034)
Revision for Implementation of ICH Q3D
Dosage forms
Semi-solid preparations for cutaneous application
(0132)
Deletion of subcategories ‘Medicated plasters’
and ‘Cutaneous patches’ to regroup them in a
separate monograph Cutaneous patches and
medicated plasters (3032)
Tablets (0478)
Revision of the Definition section of uncoated
tablets
Vaccines
Pertussis vaccine (acellular, component, adsorbed)
(1356)
Introduction of the reference to a new validated
in vitro assay for residual pertussis toxin and
irreversibility of the toxoid (general chapter 2.6.33)
Pertussis vaccine (acellular, co-purified, adsorbed)
(1595)
Introduction of the reference to a new validated
in vitro assay for residual pertussis toxin and
irreversibility of the toxoid (general chapter 2.6.33)
1
2
© Pharmeuropa | Useful information | March 2016
Poliomyelitis vaccine (oral) (0215)
Deletion of the reference to the poliomyelitis
vaccine (oral) BRP as a consequence of the WHO
Global Eradication Initiative and cessation of
poliomyelitis virus type 2 by the end of April 2016.
The OPV BRP will not be available from this date.
Radiopharmaceutical preparations
Technetium (99mTc) bicisate injection (2123)
Radiochemical purity: review of limits and
impurities
Herbal drugs
Clary sage oil (1850)
Revision of the TLC/HPTLC
Dwarf pine oil (2377)
Revision of the chromatographic profile
Eucalyptus oil (0390)
Revision of the test on solubility in alcohol
Lemon verbena leaf (1834)
Revision of the TLC/HPTLC for identification and
test
Mullein flower (1853)
Revision of the TLC
Homoeopathic preparations
Agaricus phalloides for homoeopathic preparations
(2290)
Check the possibility to insert HPTLC conditions
for Identification A (mother tincture) and to
discuss the necessity of the TLC for mother
tinctures of Amanita muscaria (test for
adulteration)
Anacardium for homoeopathic preparations (2094)
Improvement of the TLC method for
Identification B
Aurum chloratum natronatum for homoeopathic
preparations (2141)
Revision of the test for nitrates
Pillules for homoeopathic preparations (2153)
Uniformity of impregnation: addition of caffeine
method
Monographs
Acetone (0872)
Test for water: pyridine replaced by another
solvent
Alfentanil hydrochloride (1062)
Addition of Sulfated ash test
Amoxicillin sodium (0577)
Related substances
Amoxicillin trihydrate (0260)
Related substances
Aprepitant (2757)
Introduction of test for stereoisomers
Asparagine monohydrate (2086)
Revision of Ninhydrin-positive substances test
Cinchocaine hydrochloride (1088)
Related substances
Dimethyl sulfoxide (0763)
Related substances updated, test for water
(2.5.12) replaced by (2.5.32)
Erythropoietin concentrated solution (1316)
Introduction of an SST CRS in the test for dimers
and related substances of higher molecular mass
by SEC
Human anti-D immunoglobulin for intravenous
administration (1527)
Recommendation on how to perform anti-A
and anti-B haemagglutinin testing when the
concentration of the immunoglobulin is below
25 g/L
Levodropropizine (1535)
Update of Impurity C test
Macrogol stearate (1234)
Inclusion of specifications for the -32 type
Nomegestrol acetate (1551)
Revision of related substances: addition of a new
impurity
Polymyxin B sulfate (0203)
Introduction of a microbiological assay and a test
for composition
Potassium hydrogen carbonate (1141)
Revision of Sodium test
© Pharmeuropa | Useful information | March 2016
Rosuvastatin calcium (2631)
Addition of new impurities
Sodium lactate solution (1151)
Improvement of Aluminium test
Temozolomide (2780)
Water vs Loss on drying test
Vitamin A concentrate (oily form), synthetic (0219)
Revision of Peroxides test
NEW TEXTS TO BE ELABORATED
Methods of analysis
2.9.51. Accuracy of delivered doses from multidose containers
Monographs
Behenoyl macrogolglycerides (3025)
Calcium silicate (3020)
Caspofungin acetate (3029)
Ceftiofur hydrochloride for veterinary use (3031)
Cutaneous patches and medicated plasters (3032)
Dioscorea nipponica Makino rhizome dry extract (3024)
Ertapenem sodium (3030)
Isostearyl alcohol (3016)
Myristyl myristate (3017)
Polysorbate 65 (3018)
Sodium cetyl sulfate (3019)
DELETIONS FROM THE WORK PROGRAMME
(new texts or requests for revision)
Arnebia root (2426)
Canine borreliosis vaccine (inactivated) (2907)
Eupatorium herb (2717)
Farfara flower bud (2719)
Riboflavine (0292)
3