Updated work programme of the European Pharmacopoeia
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1 Pharmeuropa Useful information March Updated work programme of the European Pharmacopoeia (November 2017) The following items have been added to or deleted from the work programme during the 159 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 Microbiological examination of cell-based preparations Materials and Containers Clarification of the section dealing with method suitability Glass containers for pharmaceutical use Review of the quality of water used in the tests General monographs Products of fermentation (1468) Vaccines for veterinary use (0062) Vaccines Avian infectious bronchitis vaccine (live) (0442) Avian infectious bursal disease vaccine (live) (0587) Avian infectious encephalomyelitis vaccine (live) (0588) Avian infectious laryngotracheitis vaccine (live) (1068) Avian viral tenosynovitis vaccine (live) (1956) Bovine parainfluenza virus vaccine (live) (1176) Bovine respiratory syncytial virus vaccine (live) (1177) Canine adenovirus vaccine (live) (1951) Canine distemper vaccine (live) (0448) Canine parainfluenza virus vaccine (live) (1955) Alerting to the risk of using histidine-containing raw materials in a fermentation process ; revision to add that antibiotic use during production of IVMPs should be justified
2 2 Pharmeuropa Useful information March 2018 Canine parvovirosis vaccine (live) (0964) Distemper vaccine (live) for mustelids (0449) Duck plague vaccine (live) (1938) Duck viral hepatitis type I vaccine (live) (1315) Feline calicivirosis vaccine (live) (1102) Feline infectious enteritis (feline panleucopenia) vaccine (live) (0251) Feline viral rhinotracheitis vaccine (live) (1206) Fowl-pox vaccine (live) (0649) Infectious bovine rhinotracheitis vaccine (live) (0696) Infectious chicken anaemia vaccine (live) (2038) Marek s disease vaccine (live) (0589) Myxomatosis vaccine (live) for rabbits (1943) Newcastle disease vaccine (live) (0450) Swine-fever vaccine (live, prepared in cell cultures), classical (0065) Tetanus vaccine (adsorbed) (0452) Tetanus vaccine for veterinary use (0697) Turkey infectious rhinotracheitis vaccine (live) (2461) Herbal drugs Quillaia bark (1843) Monographs Betamethasone (0312) Betamethasone acetate (0975) Betamethasone dipropionate (0809) Betamethasone sodium phosphate (0810) Betamethasone valerate (0811) Castor oil, hydrogenated (1497) Chlorpropamide (1087) Dexamethasone (0388) Dexamethasone acetate (0548) Dexamethasone sodium phosphate (0549) Dextromethorphan hydrobromide (0020) Deletion of test for irreversibility of the tetanus toxoid Revision to delete test for irreversibility of the tetanus toxoid, to harmonise the testing method for absence of toxin with monograph Tetanus vaccine (adsorbed) (0452) and to consider harmonisation of the requirements for the toxoid Update of HPTLC method for identification Revision of Definition Addition of a test for levomethorphan
3 Pharmeuropa Useful information March Glipizide (0906) Glycerol monostearate (0495) Haemodialysis, solutions for (0128) Haemofiltration and haemodiafiltration, solutions for (0861) Hard fat (0462) Hard fat with additives (2731) Hydrochloric acid, concentrated (0002) Levomenthol (0619) Menthol, racemic (0623) Methylprednisolone (0561) Nicardipine hydrochloride (2776) Pentobarbital (0200) Pentobarbital sodium (0419) Peritoneal dialysis, solutions for (0862) Prednicarbate (1467) Prednisolone (0353) Prednisolone acetate (0734) Prednisone (0354) Revision of test for free glycerol (symmetry factor) and to allow use of two 30 cm columns instead of one 60 cm column Revision of Definition (replacement of hydrogenated by saturated) and Identification sections Revision of Definition (replacement of hydrogenated by saturated) and Identification sections Revision of test for residue on evaporation Revision of test for related substances Revision of test for related substances Following the adoption of a revised draft at the 159 th Commission session (November 2017), the monograph needs to be further revised: I) Characters: solubility section to be revised to include at least an alcohol and a lipophilic solvent. II) Identification: update of the whole section, consider the introduction of IR test and second identification series. III) Related substances consider tightening the impurity limits after having collected sufficient batch/stability data. Following the adoption of a revised draft at the 159 th Commission session (November 2017), the monograph needs to be further revised: I) Characters: solubility section to be revised to include at least an alcohol and a lipophilic solvent. II) Identification: update of the whole section, consider the introduction of IR test and second identification series. III) Appearance of solution: test to be added as the substance is used in injectable products. IV) Related substances: consider tightening the impurity limits after having collected sufficient batch/stability data.
4 4 Pharmeuropa Useful information March 2018 Rabeprazole sodium (2868) Remifentanil hydrochloride (2644) Sodium nitrite (1996) Sodium thiosulfate (0414) Squalane (1630) Triglycerides, medium-chain (0868) Urokinase (0695) Update of loss on drying test Evaluation of Loss on drying versus Water Monograph update Monograph update Revision of Identification Revision of hydroxyl value determination (analytical improvement) Deletion of rabbit pyrogen test
5 Pharmeuropa Useful information March ADDITIONS TO THE WORK PROGRAMME (new texts to be elaborated) Monocyte-activation test for vaccines containing inherently pyrogenic components Implementation of pharmacopoeial methods Cross validation N-Boc-O-dimethoxytrityl-O -nosyl-thymidine precursor for radiopharmaceutical preparations (3091) Erlotinib hydrochloride (3094) Eschscholzia herb (3088) (S)-3-(5-Formyl-4-methoxymethoxy-2-nitrophenyl)-2-(trityl-amino)-propionic acid tert-butyl ester precursor for radiopharmaceutical preparations (3093) Fulvestrant injection (3096) Helichrysi flos (3089) (2S)-O-(2 -O -Tosyloxyethyl)-N-trityl-tyrosine tert-butyl ester precursor for radiopharmaceutical preparations (3092) Vibriosis vaccine (inactivated) for sea bass (3090) Vincamine (1800) DELETIONS FROM THE WORK PROGRAMME (new texts or requests for revision) Brimonidine tartrate (2760) Sweet-fennel fruit oil (2808)
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818 INTERIM REVISION ANNOUNCEMENT Vol. 35(4) [July Aug. 2009] ERRATA Following is a list of errata and corrections to USP NF. The page number indicates where the item is found and in which official or
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