Updated work programme of the European Pharmacopoeia
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1 Pharmeuropa Useful information February Updated work programme of the European Pharmacopoeia (November 2016) The following items have been added to or deleted from the work programme during the 156 th session of the European Pharmacopoeia Commission. Consult the Knowledge Database to follow the work on individual texts. 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 Falling ball viscometer method Revision of suitability requirements for both methods Composition of fatty acids in oils rich in Revision of system suitability requirements omega-3 acids Microbiological examination of non-sterile products: test for specified micro-organisms Addition of microbiological quality requirements for orodispersible films Assay of pertussis vaccine (acellular) Uniformity of mass of delivered doses from Accuracy of delivered doses multidose containers Materials for containers and Containers Sets for the transfusion of blood and blood components Replacement of the pyrogen test by the monocyte-activation test Sterile single-use plastic syringes Replacement of the pyrogen test by the monocyte-activation test General texts Substances of animal origin for the production of immunological veterinary medicinal products General monographs Allergen products (1063) Dosage forms Ear preparations (0652) Eye preparations (1163) Liquid preparations for oral use (0672) Nasal preparations (0676) Vaccines Aujeszky s disease vaccine (inactivated) for pigs (0744) Addition of updated consolidated list of extraneous as an annex Addition of ELISA method for quantification of Bet v1 allergen Addition of a test Dose and uniformity of dose of drops Addition of a test Dose and uniformity of dose of drops Transfer of test Dose and uniformity of dose of oral drops to Tests section under Oral drops Addition of a test Dose and uniformity of dose of drops
2 2 Pharmeuropa Useful information February 2017 Calf coronavirus diarrhoea vaccine (inactivated) (1953) Calf rotavirus diarrhoea vaccine (inactivated) (1954) Diphtheria, tetanus and pertussis (acellular, component) vaccine (adsorbed) (1931) Diphtheria, tetanus and pertussis (acellular, component) vaccine (adsorbed, reduced antigen(s) content) (2764) and haemophilus type b conjugate vaccine (adsorbed) (1932) and hepatitis B (rdna) vaccine (adsorbed) (1933) and poliomyelitis (inactivated) vaccine (adsorbed) (1934) and poliomyelitis (inactivated) vaccine (adsorbed, reduced antigen(s) content) (2329), hepatitis B (rdna), poliomyelitis (inactivated) and haemophilus type b conjugate vaccine (adsorbed) (2067), poliomyelitis (inactivated) and haemophilus type b conjugate vaccine (adsorbed) (2065) Influenza vaccine (split virion, inactivated) (0158) Influenza vaccine (surface antigen, inactivated) (0869) Influenza vaccine (surface antigen, inactivated, prepared in cell cultures) (2149) Influenza vaccine (surface antigen, inactivated, virosome) (2053) Influenza vaccine (whole virion, inactivated) (0159) Influenza vaccine (whole virion, inactivated, prepared in cell cultures) (2308) Myxomatosis vaccine (live) for rabbits (1943) Pertussis vaccine (acellular, component, adsorbed) (1356) Pertussis vaccine (acellular, co-purified, adsorbed) (1595) Porcine parvovirosis vaccine (inactivated) (0965) Smallpox vaccine (live) (0164) Typhoid vaccine (0156) Yersiniosis vaccine (inactivated) for salmonids (1950) Inclusion of modified vaccinia Ankara - Bavarian Nordic (MVA-BN) virus strain Addition of serovar 3 to the scope and revision of the relative percentage survival requirements for immunogenicity
3 Pharmeuropa Useful information February Radiopharmaceutical preparations Technetium ( 99m Tc) bicisate injection (2123) Technetium ( 99m Tc) colloidal rhenium sulfide injection (0126) Technetium ( 99m Tc) colloidal sulfur injection (0131) Technetium ( 99m Tc) colloidal tin injection (0689) Technetium ( 99m Tc) etifenin injection (0585) Technetium ( 99m Tc) exametazime injection (1925) Technetium ( 99m Tc) gluconate injection (1047) Technetium ( 99m Tc) human albumin injection (0640) T echnetium ( 99m Tc) macrosalb injection (0296) Technetium ( 99m Tc) mebrofenin injection (2393) T echnetium ( 99m Tc) medronate injection (0641) Technetium ( 99m Tc) mertiatide injection (1372) Technetium ( 99m Tc) microspheres injection (0570) Technetium ( 99m Tc) oxidronate injection (2376)
4 4 Pharmeuropa Useful information February 2017 Technetium ( 99m Tc) pentetate injection (0642) Technetium ( 99m Tc) sestamibi injection (1926) Technetium ( 99m Tc) succimer injection (0643) Technetium ( 99m Tc) tin pyrophosphate injection (0129) Herbal drugs Fresh bilberry fruit dry extract, refined and standardised (2394) Indigo plant leaf (2727) Saw palmetto extract (2579) Senna leaf dry extract, standardised (1261) Homoeopathic preparations Homoeopathic preparations (1038) Monographs Acetylene intermix (1 per cent) in nitrogen (2903) Aciclovir (0968) Aluminium magnesium silicate (1388) Aprotinin (0580) Aprotinin concentrated solution (0579) Benserazide hydrochloride (1173) Carbon monoxide intermix (5 per cent) in nitrogen (2904) Castor oil, refined (2367) Cetyl palmitate (1906) Cholecalciferol concentrate (oily form) (0575) Cilastatin sodium (1408) Cytarabine (0760) Disodium phosphate dodecahydrate (0118) Fosinopril sodium (1751) Griseofulvin (0182) Hard fat (0462) Revision to widen the concentration of ethanol used for production Assay: revision of the preparation of the reference solution Revision of the test for acid value Replacement of the UV assay by HPLC Addition of homoeopathic dosage form liquid preparations for oral use Alternative method for identification of nitrogen using gas chromatography Related substances: investigation of response factor of impurity C Revision of the FRC section Revision of the test for water Alternative method for identification of nitrogen using gas chromatography Revision of the test for appearance Inclusion of an additional grade of the product Identification: deletion of the TLC method and the second identification Related substances: addition of new impurities Update of related substances test Replacement of test for water with loss on drying; revision of test for monosodium phosphate and assay Investigation of response factor of impurity K in related substances test and alternative assay method Revision of the Identification section
5 Pharmeuropa Useful information February Hard fat with additives (2731) Hydrocortisone hydrogen succinate (0768) Hypromellose (0348) Ivermectin (1336) Lauromacrogol 400 (2046) Methane intermix (2 per cent) in nitrogen (2905) Methylcellulose (0345) Nystatin (0517) Oxybutynin hydrochloride (1354) Phenytoin (1253) Poly(vinyl alcohol) (1961) Prednisone (0354) Protamine sulfate (0569) Sodium molybdate dihydrate (1565) Somatostatin (0949) Streptokinase concentrated solution (0356) Tetracosactide (0644) Tramadol hydrochloride (1681) Tylosin for veterinary use (1273) Tylosin phosphate bulk solution for veterinary use (1661) Tylosin phosphate for veterinary use (2802) Tylosin tartrate for veterinary use (1274) Revision of the Identification section Update of related substances test Assay: revision (international harmonisation) Related substances: addition of new impurities Inclusion of an assay Alternative method for identification of nitrogen using gas chromatography Assay: revision (international harmonisation) Related substances: addition of new impurity Assay: revision to replace titration with HPLC Update of description of Solution S Update of Impurities section Revision of test for appearance of solution Update of related substances test Revision of related peptides test Revision of the assay ADDITIONS TO THE WORK PROGRAMME (new texts to be elaborated) Aluminium phosphate, hydrated, for adsorption (3065) Atosiban (3054) Glatiramer (3057) Hexyl aminolevulinate hydrochloride (3062) Infectious pancreatic necrosis vaccine (inactivated) for salmonids (3063) Lanreotide (3056) Melatonin (3059) Meningococcal conjugate vaccine (groups A, C, Y, W135) (3066) Posaconazole (3058) Triptorelin (3055) Winter ulcer vaccine (inactivated, oil-adjuvanted, injectable) for salmonids (2151)
6 6 Pharmeuropa Useful information February 2017 DELETIONS FROM THE WORK PROGRAMME (new texts or requests for revision) Calamus rhizome for decoction used in TCM (2456) Ephedra distachya siccum for homoeopathic preparations (2837) Intrauterine preparations for veterinary use (1806) Nelarabine (2643) Tablets (0478) Yarrow (1382)
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