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Contents of the 6th Edition
The 6th Edition consists of all texts published in the — In monographs on antibiotics, where appropriate, the 5th Edition, which may subsequently have been revised or definition mentions that the substance is a ‘semi-synthetic product derived from a fermentation product’ or a For the information of the reader, lists are given below of monographs and general chapters that are new, or that have — In monographs on herbal drugs, the usual limit of 2 per been revised, corrected or deleted, and texts whose title has cent m/m for foreign matter has been moved from general method 2.8.2. Foreign matter to the general monograph The version date (01/2008 for volume 6.0) and the Herbal drugs (1433); this information has therefore been reference number (4 digits for monographs and 5 digits for deleted from the specific monographs for drugs covered general chapters) are specified above the title of each text (monographs and general chapters). The version date makes it possible to identify the successive versions of revised texts — In monographs on herbal drugs, the reference to in different volumes of the 6th Edition. Corrections that are identifications A and B (macroscopic and microscopic indicated by the note ‘corrected 6.0’ under the version date descriptions) has been deleted from the Characters are to be taken into account from the publication date of — In accordance with the general monograph Substances For the 6th Edition, the following systematic modifications for pharmaceutical use (2034), the content of residual have been made to the texts of the European Pharmacopoeia.
solvent is taken into account for calculation of the assay content of the substance, the specific optical rotation and — In the test for loss on drying (2.2.32) in the monographs, the specific absorbance. This information is therefore no the temperature range of 100-105 °C has been replaced longer indicated in the specific monographs concerned.
by 105 °C alone (as the general method states that drying is carried out at the prescribed temperature ± 2 °C), to — The general monographs Herbal drugs (1433) and follow the approach adopted by the Pharmacopoeial Extracts (0765) specify storage protected from light; this Discussion Group for pharmacopoeial harmonisation.
information has therefore been deleted from the specific — In the test for loss on ignition in the monographs, a monographs on substances and preparations covered by temperature range has been introduced.
— In tests using atomic absorption spectrometry and atomic — A reference to general chapter 2.1.2. Comparative table emission spectrometry, the precision of the limits has of porosity of sintered-glass filters has been added whenever reference is made to ‘sintered-glass filters’.
— In the Characters section, ‘white’ has been replaced by — A reference to general chapter 2.9.12. Sieve test has been added whenever particle or granule size is indicated by — In the Labelling section, it will no longer be mentioned that, where appropriate, the label includes statements that the substance is free from bacterial endotoxins, — A reference to general chapter 5.9. Polymorphism has free from pyrogens and sterile since this information is been added to monographs in which polymorphism is already included in the general monograph Substances for pharmaceutical use (2034). This also applies to the indication of the name and the concentration of any — Where the heading ‘Other detectable impurities’ appears added substance (excipient, antioxidant, etc.).
in the Impurities section of a monograph, it is now followed by: ‘(the following substances would, if present — In the transparency list, letters designating an impurity at a sufficient level, be detected by one or other of followed by ‘deleted’ will no longer be included in the the tests in the monograph. They are limited by the monographs; it is now permissible for the list of impurities general acceptance criterion for other/unspecified impurities and/or by the general monograph Substances for pharmaceutical use (2034). It is therefore not — Where appropriate, the Chemical Abstracts Service necessary to identify these impurities for demonstration (CAS) registration numbers are given for information in of compliance. See also 5.10. Control of impurities in substances for pharmaceutical use)’.
— The retention factor R has been replaced by the — Many monographs have been converted to the new editorial style, which does not entail any changes to their — In monographs on antibiotics, the upper limit of content technical content. The list of monographs on chemical has been increased to 102 per cent when an assay is substances and herbal drugs concerned is available on carried out using liquid chromatography.
Contents of the 6th Edition
A vertical line in the margin indicates where part of a text has been revised or corrected. A horizontal line in the margin indicates where part of a text has been deleted. It is to be emphasised that these indications, which are not necessarily exhaustive, are given for information and do not form an official part of the texts. Editorial changes are not indicated.
Individual copies of texts will not be supplied.
NEW TEXTS INCLUDED IN THE 6th EDITION
GENERAL CHAPTERS
2.2.57. Inductively coupled plasma-atomic emission 2.2.58. Inductively coupled plasma-mass spectrometry 2.7.28. Colony-forming cell assay for human haematopoietic Felbinac (2304) 2.7.29. Nucleated cell count and viability 2.8.20. Herbal drugs: sampling and sample preparation 2.9.41. Friability of granules and spheroids Glycerol monocaprylate (2213)Glycerol monocaprylocaprate (2392) MONOGRAPHS
The monographs below appear for the first time in the European Pharmacopoeia. They will be implemented on 1 January 2008 at the latest.
Vaccines for human use
Cholera vaccine (inactivated, oral) (2327) Microcrystalline cellulose and carmellose sodium (2050) Vaccines for veterinary use
Rabbit haemorrhagic disease vaccine (inactivated) (2325) Radiopharmaceutical preparations
Fluorodopa (18F) (prepared by electrophilic substitution) Ropivacaine hydrochloride monohydrate (2335) Monographs
REVISED TEXTS IN THE 6th EDITION
GENERAL CHAPTERS
Vaccines for human use
Influenza vaccine (surface antigen, inactivated, virosome) Vaccines for veterinary use
Avian infectious bursal disease vaccine (inactivated) (0960) Monographs
5.1.4. Microbiological quality of pharmaceutical Statistical analysis of results of biological assays and Ascorbyl palmitate (0807) MONOGRAPHS
The monographs below have been technically revised since their last publication. They will be implemented on 1 January 2008.
Cefamandole nafate (1402)Cefepime dihydrochloride monohydrate (2126) General monographs
Monoclonal antibodies for human use (2031) Cholecalciferol (0072)Chondroitin sulphate sodium (2064) Dosage forms
Contents of the 6th Edition
Erythropoietin concentrated solution (1316) Paroxetine hydrochloride, anhydrous (2283) Paroxetine hydrochloride hemihydrate (2018) Pentaerythrityl tetranitrate, diluted (1355) Perindopril tert-butylamine (2019) Human anti-D immunoglobulin for intravenous CORRECTED TEXTS IN THE 6th EDITION
The texts below from the 5th Edition have been modified and specify ‘01/2008:XXXX-corrected 6.0’ above the title. These modifications are to be taken into account from the publication date of the 6th Edition. GENERAL CHAPTERS
3.1.1.1. Materials based on plasticised poly(vinyl chloride) for containers for human blood and blood components 3.1.1.2. Materials based on plasticised poly(vinyl chloride) for tubing used in sets for the transfusion of blood 2.4.29. Composition of fatty acids in oils rich in omega-3 3.1.4. Polyethylene without additives for containers for parenteral preparations and for ophthalmic 3.1.5. Polyethylene with additives for containers for 2.6.13. Microbiological examination of non-sterile products: parenteral preparations and for ophthalmic 3.1.6. Polypropylene for containers and closures for parenteral preparations and ophthalmic preparations 3.1.10. Materials based on non-plasticised poly(vinyl chloride) for containers for non-injectable, aqueous 2.8.12. Determination of essential oils in herbal drugs Contents of the 6th Edition
3.1.11. Materials based on non-plasticised poly(vinyl Homoeopathic preparations
chloride) for containers for dry dosage forms for oral Cadmium sulphate hydrate for homoeopathic preparations 3.1.14. Materials based on plasticised poly(vinyl chloride) for containers for aqueous solutions for intravenous Common stinging nettle for homoeopathic preparations 3.1.15. Polyethylene terephthalate for containers for Copper acetate monohydrate for homoeopathic preparations 3.2.2.1. Plastic containers for aqueous solutions for infusion Copper for homoeopathic preparations (1610) 3.2.9. Rubber closures for containers for aqueous Hedera helix for homoeopathic preparations (2092) parenteral preparations, for powders and for Hyoscyamus for homoeopathic preparations (2091) 5.2.1. Terminology used in monographs on biological Hypericum for homoeopathic preparations (2028) Iron for homoeopathic preparations (2026) Gene transfer medicinal products for human use Oriental cashew for homoeopathic preparations (2094) MONOGRAPHS
Saffron for homoeopathic preparations (1624) General monographs
Monographs
Vaccines for human use
Diphtheria, tetanus and pertussis (acellular, component) Diphtheria, tetanus, pertussis (acellular, component) and haemophilus type b conjugate vaccine (adsorbed) (1932) Diphtheria, tetanus, pertussis (acellular, component) and hepatitis B (rDNA) vaccine (adsorbed) (1933) Diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine (adsorbed) (1934) Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and haemophilus type b conjugate vaccine (adsorbed) (2067) Diphtheria, tetanus, pertussis (acellular, component), poliomyelitis (inactivated) and haemophilus type b conjugate Haemophilus type b conjugate vaccine (1219) Meningococcal group C conjugate vaccine (2112) Pertussis vaccine (acellular, component, adsorbed) (1356) Pertussis vaccine (acellular, co-purified, adsorbed) (1595) Vaccines for veterinary use
Aujeszky’s disease vaccine (live) for pigs for parenteral Bovine parainfluenza virus vaccine (live) (1176) Bovine respiratory syncytial virus vaccine (live) (1177) Brucellosis vaccine (live) (Brucella melitensis Rev. 1 strain) Distemper vaccine (live) for mustelids (0449) Feline calicivirosis vaccine (live) (1102) Infectious bovine rhinotracheitis vaccine (live) (0696) Radiopharmaceutical preparations
Indium (111In) pentetate injection (0670) Strontium (89Sr) chloride injection (1475) Technetium (99mTc) macrosalb injection (0296) Contents of the 6th Edition
Bismuth subsalicylate (1495)Bitter-orange flower (1810) Basic butylated methacrylate copolymer (1975) Beclometasone dipropionate, anhydrous (0654) Beclometasone dipropionate monohydrate (1709) Contents of the 6th Edition
Calcium hydrogen phosphate, anhydrous (0981) Calcium hydrogen phosphate dihydrate (0116) Cholecalciferol concentrate (oily form) (0575) Cholecalciferol concentrate (powder form) (0574) Cholecalciferol concentrate (water-dispersible form) (0598) Carmellose sodium, low-substituted (1186) Cetostearyl alcohol (type A), emulsifying (0801) Cysteine hydrochloride monohydrate (0895) Contents of the 6th Edition
Detomidine hydrochloride for veterinary use (1414) Flunixin meglumine for veterinary use (1696) Emetine hydrochloride heptahydrate (0080) Emetine hydrochloride pentahydrate (0081) Contents of the 6th Edition
Insulin injection, biphasic isophane (0832) Insulin zinc injectable suspension (0837) Insulin zinc injectable suspension (amorphous) (0835) Insulin zinc injectable suspension (crystalline) (0836) Haemodialysis solutions, concentrated, water for diluting Hawthorn leaf and flower dry extract (1865) Histidine hydrochloride monohydrate (0910) Human antithrombin III concentrate (0878) Contents of the 6th Edition
Methacrylic acid - ethyl acrylate copolymer (1:1) dispersion Methacrylic acid - methyl methacrylate copolymer (1:1) Methacrylic acid - methyl methacrylate copolymer (1:2) Macrogol 6 glycerol caprylocaprate (1443) Methylprednisolone hydrogen succinate (1131) Minocycline hydrochloride dihydrate (1030) Morantel hydrogen tartrate for veterinary use (1546) Methacrylic acid - ethyl acrylate copolymer (1:1) (1128) Contents of the 6th Edition
Polyacrylate dispersion 30 per cent (0733) Poly(vinyl acetate) dispersion 30 per cent (2152) Potassium hydrogen aspartate hemihydrate (2076) Potassium sodium tartrate tetrahydrate (1986) Contents of the 6th Edition
Silver, colloidal, for external use (2281) Sodium dihydrogen phosphate dihydrate (0194) Pyridoxine hydrochloride (0245)Pyrimethamine (0288) Contents of the 6th Edition
Sulfamethoxypyridazine for veterinary use (0638) Wild pansy (flowering aerial parts) (1855) Xylazine hydrochloride for veterinary use (1481) Tiamulin hydrogen fumarate for veterinary use (1659) Contents of the 6th Edition
TEXTS WHOSE TITLE HAS CHANGED FOR THE 6th EDITION
The titles of the following texts have been changed in the 6th Edition. GENERAL CHAPTERS
Bovine respiratory syncytial virus vaccine (live) (1177) 2.8.12. Determination of essential oils in herbal drugs (previously Bovine respiratory syncytial virus vaccine (previously Determination of essential oils in Brucellosis vaccine (live) (Brucella melitensis Rev. 1 strain) 3.2.2.1. Plastic containers for aqueous solutions for infusion for veterinary use (0793) (previously Brucellosis vaccine (previously Plastic containers for aqueous solutions (live) (Brucella melitensis Rev. 1 strain), freeze-dried, for 5.2.1. Terminology used in monographs on biological Canine distemper vaccine (live) (0448) (previously Canine products (previously Terminology used in distemper vaccine (live), freeze-dried) Distemper vaccine (live) for mustelids (0449) (previously Distemper vaccine (live) for mustelids, freeze-dried) MONOGRAPHS
Feline calicivirosis vaccine (live) (1102) (previously Feline calicivirosis vaccine (live), freeze-dried) Vaccines for veterinary use
Infectious bovine rhinotracheitis vaccine (live) (0696) Aujeszky’s disease vaccine (live) for pigs for parenteral (previously Infectious bovine rhinotracheitis vaccine (live), administration (0745) (previously Aujeszky’s disease vaccine (live) for pigs for parenteral administration, Monographs
Pine sylvestris oil (1842) (previously pine silvestris oil) Bovine parainfluenza virus vaccine (live) (1176) (previously Silica, hydrophobic colloidal (2208) (previously Silica, Bovine parainfluenza virus vaccine (live), freeze-dried) TEXTS DELETED FOR THE 6th EDITION
The following texts are deleted as of 1 January 2008.
GENERAL CHAPTERS
MONOGRAPHS
2.9.24. Resistance to rupture of suppositories and pessaries Monographs
2.9.28. Test for deliverable mass or volume of liquid and

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