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Contents of the 7th Edition
IV. CONTENTS OF THE 7th EDITIONThe 7th Edition consists of all texts published in the 6th Edition, — In several monographs on essential oils, information that which may subsequently have been revised or corrected, and already appears in the general monograph Essential oils (2098) has been deleted. The expression of limits of content For the information of the reader, lists are given below of for components has been modified (‘less than’ replaced by monographs and general chapters that are new, or that have been revised, corrected or deleted, and texts whose title has — The number of significant figures in the expression of limits has been modified (mainly in atomic emission spectrometry The version date (for example 01/2011 for a text that is new or and atomic absorption spectrometry tests).
revised for the 7th Edition), completed by ‘corrected X.X’ if a corrected version of the text has subsequently been published — Where appropriate, reference to general chapter 2.2.22. in Supplement X.X, and the reference number (4 digits for Atomic emission spectrometry is being progressively monographs and 5 digits for general chapters) are specified replaced by reference to general chapter 2.2.57. Inductively above the title of each text (monographs and general chapters).
coupled plasma-atomic emission spectrometry.
The version date, completed by ‘corrected X.X’ if appropriate, — Information in the gradient tables of liquid chromatography makes it possible to identify the successive versions of texts in tests is being progressively harmonised (under normal different editions. From the 7th Edition, if a text has not been conditions, information concerning the return to initial revised for a new Edition, the version date published in the previous Edition will be kept in order to improve traceability.
The volume in which this version has been published for the first — Reference to the new method H for heavy metals has been time is stated in the Knowledge database on the EDQM website.
A vertical line in the margin indicates where part of a text has — The graphic formulae and nomenclature of impurities that been revised or corrected. A horizontal line in the margin are the subject of a monograph have been introduced in the indicates where part of a text has been deleted. However, these indications, which are not necessarily exhaustive, are given — The symbol ‘l’ for litre has been replaced by ‘L’.
for information and do not form an official part of the texts.
Editorial changes are not indicated.
— The stem ‘sulph’ has been replaced by ‘sulf’.
Lines in the margin that were present in revised or corrected — The term ‘parenteral dosage form’ has been replaced by texts in the previous Edition will be deleted with each new ‘parenteral preparation’ and the term ‘parenteral use’ has been replaced by ‘parenteral administration’, where Corrections that are indicated by the note ‘corrected 7.0’ under the version date are to be taken into account from the — The presentation of monographs on materials used for the manufacture of containers, monographs on containers, For the 7th Edition, the following decisions and systematic several monographs on radiopharmaceutical preparations modifications to the texts of the European Pharmacopoeia have and some other monographs has been harmonised by converting them into the new drafting style, which does not — Monographs on herbal drugs and herbal drug preparations entail any changes to their technical content. The list of have been published in a separate chapter in volume 1.
monographs concerned is available on the EDQM website.
— Where appropriate, monographs on herbal drugs are being For monographs on radiopharmaceutical preparations, progressively revised to incorporate the legend of the details of the production procedure when various possibilities illustration of the powdered herbal drug into the text of exist have been moved from the Definition section to the Individual copies of texts published in this Edition will not be supplied.
Subscribers to the current version (printed or electronic) of the European Pharmacopoeia have access to an archive version
of all previous editions of the European Pharmacopoeia. NEW TEXTS INCLUDED IN THE 7th EDITION
The texts below appear for the first time in the European Pharmacopoeia. They will be implemented on 1 January 2011
GENERAL CHAPTERS
Herbal drugs and herbal drug preparations
2.8.21. Test for aristolochic acids in herbal drugs Fourstamen stephania root (2478)
Monographs
Amylmetacresol (2405)
MONOGRAPHS
Radiopharmaceutical preparations and starting materials for
radiopharmaceutical preparations
Fluoride (18F) solution for radiolabelling (2390) Contents of the 7th Edition
Lufenuron (anhydrous) for veterinary use (2177) Valaciclovir hydrochloride, anhydrous (1768) Ziprasidone hydrochloride monohydrate (2421) REVISED TEXTS IN THE 7th EDITION
The texts below have been technically revised since their last publication. They will be implemented on 1 January 2011 unless
otherwise indicated by a footnote. GENERAL CHAPTERS
Homoeopathic preparations
Methods of preparation of homoeopathic stocks and Monographs
2.6.16. Tests for extraneous agents in viral vaccines for human Acetylsalicylic acid (0309) 2.6.27. Microbiological control of cellular products Aprotinin (0580)Aprotinin concentrated solution (0579) Microbiological quality of non-sterile pharmaceutical preparations and substances for pharmaceutical use Cell substrates for the production of vaccines for Buflomedil hydrochloride (1398)Calcium acetate (2128) MONOGRAPHS
Vaccines for human use
Measles, mumps, rubella and varicella vaccine (live) (2442) Radiopharmaceutical preparations and starting materials for
radiopharmaceutical preparations
Clebopride malate (1303)Codeine phosphate hemihydrate (0074) Tetra-O-acetyl-mannose triflate for radiopharmaceutical Herbal drugs and herbal drug preparations
Fish oil, rich in omega-3 acids (1912)Flucytosine (0766) Haemofiltration and haemodiafiltration, solutions for (0861) Human antithrombin III concentrate (0878) Human coagulation factor IX (1223)Human coagulation factor XI (1644) Liquorice ethanolic liquid extract, standardised (1536) Human plasma (pooled and treated for virus inactivation) (1646) (1) This text entered into force on 1 August 2010.
Contents of the 7th Edition
Peritoneal dialysis, solutions for (0862) α-Tocopheryl acetate concentrate (powder form) (0691) CORRECTED TEXTS IN THE 7th EDITION
The texts below from the 6th Edition have been corrected and specify ‘corrected 7.0’ above the title. These corrections are to be taken into account from the publication date of the 7th Edition (15 July 2010).
GENERAL CHAPTERS
Radiopharmaceutical preparations and starting materials for
radiopharmaceutical preparations
Ammonia (13N) injection (1492)
Cyanocobalamin (58Co) capsules (1505)Cyanocobalamin (58Co) solution (0270) 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 and Indium (111In) pentetate injection (0670) Polyethylene with additives for containers for parenteral Iobenguane (123I) injection (1113) preparations and for ophthalmic preparations Iobenguane (131I) injection for diagnostic use (1111) Polypropylene for containers and closures for Iobenguane (131I) injection for therapeutic use (1112) parenteral preparations and ophthalmic preparations Iodomethylnorcholesterol (131I) injection (0939) 3.1.10. Materials based on non-plasticised poly(vinyl chloride) Sodium chromate (51Cr) sterile solution (0279) for containers for non-injectable, aqueous solutions Sodium iodohippurate (123I) injection (0564) 3.1.11. Materials based on non-plasticised poly(vinyl Sodium iodohippurate (131I) injection (0282) chloride) for containers for dry dosage forms for oral Sodium pertechnetate (99mTc) injection (fission) (0124) 3.1.14. Materials based on plasticised poly(vinyl chloride) Sodium pertechnetate (99mTc) injection (non-fission) (0283) for containers for aqueous solutions for intravenous Strontium (89Sr) chloride injection (1475) 3.1.15. Polyethylene terephthalate for containers for Technetium (99mTc) colloidal rhenium sulfide injection (0126) Technetium (99mTc) colloidal sulfur injection (0131) Rubber closures for containers for aqueous parenteral Technetium (99mTc) colloidal tin injection (0689) preparations, for powders and for freeze-dried powders Technetium (99mTc) gluconate injection (1047) Technetium (99mTc) human albumin injection (0640) MONOGRAPHS
Technetium (99mTc) macrosalb injection (0296)Technetium (99mTc) medronate injection (0641) Vaccines for veterinary use
Technetium (99mTc) mertiatide injection (1372) Anthrax spore vaccine (live) for veterinary use (0441) Technetium (99mTc) microspheres injection (0570) Contents of the 7th Edition
Technetium (99mTc) pentetate injection (0642) Technetium (99mTc) succimer injection (0643) Technetium (99mTc) tin pyrophosphate injection (0129) Thallous (201Tl) chloride injection (0571) Herbal drugs and herbal drug preparations
Carmellose sodium, low-substituted (1186) Chlorhexidine digluconate solution (0658) Turpentine oil, Pinus pinaster type (1627) Homoeopathic preparations
Copper for homoeopathic preparations (1610) Closantel sodium dihydrate for veterinary use (1716) Iron for homoeopathic preparations (2026) Monographs
Beclometasone dipropionate, anhydrous (0654) Beclometasone dipropionate monohydrate (1709) Contents of the 7th Edition
Haemodialysis solutions, concentrated, water for diluting (1167) Potassium hydrogen carbonate (1141)Human albumin solution (0255) Hydrocodone hydrogen tartrate 2.5-hydrate (1784) Interferon gamma-1b concentrated solution (1440) Methacrylic acid - ethyl acrylate copolymer (1:1) (1128) Spirapril hydrochloride monohydrate (1766) Microcrystalline cellulose and carmellose sodium (2050) Minocycline hydrochloride dihydrate (1030) Tilidine hydrochloride hemihydrate (1767) Pirenzepine dihydrochloride monohydrate (2001) Contents of the 7th Edition
TEXTS WHOSE TITLE HAS CHANGED FOR THE 7th EDITION
The titles of the following texts have been changed in the 7th Edition. MONOGRAPHS
Monographs
Radiopharmaceutical preparations and starting materials for
Calcium acetate, anhydrous (2128) (previously Calcium acetate) radiopharmaceutical preparations
Iodomethylnorcholesterol (131I) injection (0939) (previously
Meclozine dihydrochloride (0622) (previously Meclozine Norcholesterol injection, iodinated (131I)) TEXTS DELETED FOR THE 7th EDITION
The following text is deleted as of 1 January 2011.
MONOGRAPHS
Monographs
Gallamine triethiodide (0181)
For the following corrected texts published in Supplement 6.3, please read ‘corrected 6.3’ instead of ‘corrected 6.0’. This correction has been taken into account in the 7th Edition. MONOGRAPHS
Monographs
Glucose, anhydrous (0177)
Glucose monohydrate (0178)

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