EUROPEAN PHARMACOPOEIA 7.

0 Contents of the 7th Edition

IV. CONTENTS OF THE 7th EDITION

The 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
new texts. (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 ‘maximum’).
been revised, corrected or deleted, and texts whose title has — The number of significant figures in the expression of limits
been changed for the 7th Edition. 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 conditions is being deleted).
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. introduced where appropriate.
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 transparency list.
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’
Edition. has been replaced by ‘parenteral administration’, where
Corrections that are indicated by the note ‘corrected 7.0’ appropriate.
under the version date are to be taken into account from the
publication date of the volume. — 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
been made. 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
identification test B. Knowledge database.

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
at the latest.

GENERAL CHAPTERS Herbal drugs and herbal drug preparations

2.2.59. Glycan analysis of glycoproteins Astragalus mongholicus root (2435)
Fourstamen stephania root (2478)
2.8.21. Test for aristolochic acids in herbal drugs
Monographs
Amylmetacresol (2405)
MONOGRAPHS Carbon monoxide (2408)
Radiopharmaceutical preparations and starting materials for Cefpodoxime proxetil (2341)
radiopharmaceutical preparations Entacapone (2574)
Fluoride (18F) solution for radiolabelling (2390) Levetiracetam (2535)

xvii
Contents of the 7th Edition EUROPEAN PHARMACOPOEIA 7.0

Lufenuron (anhydrous) for veterinary use (2177) Sucralfate (1796)

Meropenem trihydrate (2234) Trimebutine maleate (2182)
Starch, hydroxypropyl (2165) Valaciclovir hydrochloride, anhydrous (1768)
Starches, hydroxyethyl (1785) 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
2.5.24. Carbon dioxide in gases Homoeopathic preparations (1038)
2.5.25. Carbon monoxide in gases Methods of preparation of homoeopathic stocks and
potentisation (2371)
2.5.35. Nitrous oxide in gases Monographs
2.6.16. Tests for extraneous agents in viral vaccines for human Acetylsalicylic acid (0309)
use Aciclovir (0968)
2.6.27. Microbiological control of cellular products
Aluminium oxide, hydrated (0311)
2.7.14. Assay of hepatitis A vaccine Ambroxol hydrochloride (1489)
5.1.2. Biological indicators of sterilisation Aminoglutethimide (1291)
Aprotinin (0580)
5.1.3. Efficacy of antimicrobial preservation
Aprotinin concentrated solution (0579)
5.1.4. Microbiological quality of non-sterile pharmaceutical Ascorbic acid (0253)
preparations and substances for pharmaceutical use
Azithromycin (1649)
5.2.3. Cell substrates for the production of vaccines for
human use Benazepril hydrochloride (2388)
5.8. Pharmacopoeial harmonisation Buflomedil hydrochloride (1398)
Calcium acetate (2128)
MONOGRAPHS Captopril (1079)
Vaccines for human use Carrageenan (2138)
Measles, mumps, rubella and varicella vaccine (live) (2442) Chlorocresol (0384)
Chymotrypsin (0476)
Varicella vaccine (live) (0648)
Cladribine (2174)
Radiopharmaceutical preparations and starting materials for
radiopharmaceutical preparations Clebopride malate (1303)
Codeine phosphate hemihydrate (0074)
Tetra-O-acetyl-mannose triflate for radiopharmaceutical
preparations (2294) Danaparoid sodium (2090)
Fish oil, rich in omega-3 acids (1912)
Herbal drugs and herbal drug preparations
Flucytosine (0766)
Agrimony (1587)
Fluoxetine hydrochloride (1104)
Angelica root (1857)
Fluspirilene (1723)
Artichoke leaf (1866) Fosfomycin calcium (1328)
Butcher’s broom (1847) Fosinopril sodium (1751)
Calendula flower (1297) Ganciclovir (1752)
Capsicum (1859) Glycerol monocaprylocaprate (2392)
Cinchona bark (0174) Gonadotrophin, chorionic (0498)
Dandelion root (1852) Haemodialysis, solutions for (0128)
Devil’s claw root (1095) Haemofiltration and haemodiafiltration, solutions for (0861)
Ginger (1522) Heparin calcium (0332)(1)
Ginkgo leaf (1828) Heparin sodium (0333)(1)
Goldenseal rhizome (1831) Human antithrombin III concentrate (0878)
Hamamelis leaf (0909) Human coagulation factor VII (1224)
Human coagulation factor IX (1223)
Hop strobile (1222)
Human coagulation factor XI (1644)
Liquorice ethanolic liquid extract, standardised (1536)
Human fibrinogen (0024)
Mallow flower (1541)
Human normal immunoglobulin (0338)
Melissa leaf (1447) Human plasma (pooled and treated for virus inactivation) (1646)
Mullein flower (1853) Human prothrombin complex (0554)
Nettle leaf (1897) Human von Willebrand factor (2298)
Oregano (1880) Hydrocortisone (0335)
Peppermint leaf (0406) Insulin, human (0838)
Red poppy petals (1881) Ioxaglic acid (2009)

(1) This text entered into force on 1 August 2010.

xviii
EUROPEAN PHARMACOPOEIA 7.0 Contents of the 7th Edition

Isoprenaline hydrochloride (1332) Sertraline hydrochloride (1705)

Isotretinoin (1019) Silica, colloidal anhydrous (0434)
Itraconazole (1335) Silica, dental type (1562)
Levodropropizine (1535) Silica, hydrophobic colloidal (2208)
Lisinopril dihydrate (1120) Sodium ascorbate (1791)
Meclozine dihydrochloride (0622) Sodium hyaluronate (1472)
Methylphenobarbital (0189) Sodium lactate solution (1151)
Nicotinic acid (0459) Sodium propyl parahydroxybenzoate (1263)
Nimesulide (1548) Somatostatin (0949)
Ofloxacin (1455) Spironolactone (0688)
Omeprazole sodium (1032) Sulfinpyrazone (0790)
Pancreas powder (0350) Talc (0438)
Peritoneal dialysis, solutions for (0862) Timolol maleate (0572)
Phentolamine mesilate (1138) Titanium dioxide (0150)
Phloroglucinol, anhydrous (2301) -Tocopheryl acetate concentrate (powder form) (0691)
Phloroglucinol dihydrate (2302) Tolbutamide (0304)
Polysorbate 80 (0428) Tretinoin (0693)
Protamine hydrochloride (0686) Triflusal (1377)
Protamine sulfate (0569) Tropicamide (1159)
Risperidone (1559) Trypsin (0694)
Salbutamol (0529) Zolpidem tartrate (1280)

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
1. General notices radiopharmaceutical preparations
Ammonia (13N) injection (1492)
2.4.15. Nickel in polyols
Chromium (51Cr) edetate injection (0266)
2.6.14. Bacterial endotoxins Cyanocobalamin (57Co) capsules (0710)
2.7.2. Microbiological assay of antibiotics Cyanocobalamin (57Co) solution (0269)
2.7.30. Assay of human protein C Cyanocobalamin (58Co) capsules (1505)
Cyanocobalamin (58Co) solution (0270)
3.1.1.1. Materials based on plasticised poly(vinyl chloride) for Fludeoxyglucose (18F) injection (1325)
containers for human blood and blood components
Gallium (67Ga) citrate injection (0555)
3.1.1.2. Materials based on plasticised poly(vinyl chloride) for
tubing used in sets for the transfusion of blood and Indium (111In) chloride solution (1227)
blood components Indium (111In) oxine solution (1109)
3.1.3. Polyolefines Indium (111In) pentetate injection (0670)
123
3.1.5. Polyethylene with additives for containers for parenteral Iobenguane (131 I) injection (1113)
preparations and for ophthalmic preparations Iobenguane ( I) injection for diagnostic use (1111)
3.1.6. 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)
administration
3.1.14. Materials based on plasticised poly(vinyl chloride) Sodium pertechnetate (99mTc) injection (non-fission) (0283)
for containers for aqueous solutions for intravenous Sodium phosphate (32P) injection (0284)
infusion Strontium (89Sr) chloride injection (1475)
3.1.15. Polyethylene terephthalate for containers for Technetium (99mTc) colloidal rhenium sulfide injection (0126)
preparations not for parenteral use Technetium (99mTc) colloidal sulfur injection (0131)
3.2.9. 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)

xix
Contents of the 7th Edition EUROPEAN PHARMACOPOEIA 7.0

Technetium (99mTc) pentetate injection (0642) Buprenorphine (1180)

Technetium (99mTc) succimer injection (0643) Calcipotriol, anhydrous (2011)
Technetium (99mTc) tin pyrophosphate injection (0129) Calcium ascorbate (1182)
Thallous (201Tl) chloride injection (0571) Calcium dobesilate monohydrate (1183)
Tritiated (3H) water injection (0112) Calcium folinate (0978)
Water (15O) injection (1582) Calcium gluconate for injection (0979)
Xenon (133Xe) injection (0133) Calcium levofolinate pentahydrate (1606)
Herbal drugs and herbal drug preparations Calcium stearate (0882)
Anise oil (0804) D-Camphor (1400)
Bitter-fennel herb oil (2380) Carbasalate calcium (1185)
Cassia oil (1496) Carboplatin (1081)
Cinnamon bark oil, Ceylon (1501) Carmellose (2360)
Cinnamon leaf oil, Ceylon (1608) Carmellose sodium, low-substituted (1186)
Citronella oil (1609) Carprofen for veterinary use (2201)
Clary sage oil (1850) Cefadroxil monohydrate (0813)
Eleutherococcus (1419) Cefalexin monohydrate (0708)
Ivy leaf (2148) Cefalotin sodium (0987)
Juniper oil (1832) Cefamandole nafate (1402)
Liquorice root (0277) Cellulose, microcrystalline (0316)
Mandarin oil (2355) Charcoal, activated (0313)
Nutmeg oil (1552) Chlorcyclizine hydrochloride (1086)
Safflower flower (2386) Chlorhexidine diacetate (0657)
Spanish sage oil (1849) Chlorhexidine digluconate solution (0658)
Spike lavender oil (2419) Chlorhexidine dihydrochloride (0659)
Star anise oil (2108) Chlorpromazine hydrochloride (0475)
Tea tree oil (1837) Cisplatin (0599)
Turpentine oil, Pinus pinaster type (1627) Clarithromycin (1651)
Homoeopathic preparations Clopamide (1747)
Copper for homoeopathic preparations (1610) Closantel sodium dihydrate for veterinary use (1716)
Iron for homoeopathic preparations (2026) Codeine (0076)
Monographs Colchicine (0758)
Acebutolol hydrochloride (0871) Copper sulfate, anhydrous (0893)
Acemetacin (1686) Copper sulfate pentahydrate (0894)
Acetylcysteine (0967) Cotton, absorbent (0036)
N-Acetyltryptophan (1383) Cottonseed oil, hydrogenated (1305)
Acitretin (1385) Desflurane (1666)
Alfentanil hydrochloride (1062) Diclazuril for veterinary use (1718)
Almagate (2010) Didanosine (2200)
Aluminium magnesium silicate (1388) Digoxin (0079)
Aluminium sodium silicate (1676) Dihydroergocristine mesilate (1416)
Amikacin sulfate (1290) Dipivefrine hydrochloride (1719)
Amisulpride (1490) Dipotassium phosphate (1003)
Ammonium glycyrrhizate (1772) Dopexamine dihydrochloride (1748)
Arachis oil, hydrogenated (1171) Doxazosin mesilate (2125)
Ascorbyl palmitate (0807) Econazole (2049)
Atropine sulfate (0068) Econazole nitrate (0665)
Azaperone for veterinary use (1708) Enalaprilat dihydrate (1749)
Azathioprine (0369) Enrofloxacin for veterinary use (2229)
Barium sulfate (0010) Epinastine hydrochloride (2411)
Beclometasone dipropionate, anhydrous (0654) Etomidate (1514)
Beclometasone dipropionate monohydrate (1709) Felypressin (1634)
Benzalkonium chloride (0372) Fenbendazole for veterinary use (1208)
Benzalkonium chloride solution (0371) Fenbufen (1209)
Benzoyl peroxide, hydrous (0704) Ferrous fumarate (0902)
Betadex (1070) Ferrous sulfate, dried (2340)
Bismuth subcarbonate (0012) Filgrastim concentrated solution (2206)
Bismuth subgallate (1493) Flubendazole (1721)
Bismuth subnitrate, heavy (1494) Flunarizine dihydrochloride (1722)
Bismuth subsalicylate (1495) Fluorescein (2348)
Bleomycin sulfate (0976) Fluphenazine decanoate (1014)
Brotizolam (2197) Fluphenazine enantate (1015)

xx
EUROPEAN PHARMACOPOEIA 7.0 Contents of the 7th Edition

Formoterol fumarate dihydrate (1724) Polysorbate 20 (0426)

Galantamine hydrobromide (2366) Polysorbate 40 (1914)
Gelatin (0330) Polysorbate 60 (0427)
Gemfibrozil (1694) Potassium acetate (1139)
Glibenclamide (0718) Potassium chloride (0185)
Gonadorelin acetate (0827) Potassium citrate (0400)
Guaifenesin (0615) Potassium dihydrogen phosphate (0920)
Haemodialysis solutions, concentrated, water for diluting (1167) Potassium hydrogen carbonate (1141)
Human albumin solution (0255) Potassium metabisulfite (2075)
Hydrocodone hydrogen tartrate 2.5-hydrate (1784) Potassium nitrate (1465)
Ibuprofen (0721) Povidone (0685)
Imipramine hydrochloride (0029) Praziquantel (0855)
myo-Inositol (1805) Prazosin hydrochloride (0856)
Interferon gamma-1b concentrated solution (1440) Procaine hydrochloride (0050)
Irbesartan (2465) Propafenone hydrochloride (2103)
Ketobemidone hydrochloride (1746) Propyl gallate (1039)
Lauromacrogol 400 (2046) Ramipril (1368)
Levamisole for veterinary use (1728) Ranitidine hydrochloride (0946)
Levodopa (0038) Rifamycin sodium (0432)
Lithium carbonate (0228) Rutoside trihydrate (1795)
Loperamide hydrochloride (0929) Salbutamol sulfate (0687)
Loperamide oxide monohydrate (1729) Sodium alginate (0625)
Macrogol 40 sorbitol heptaoleate (2396) Sodium aminosalicylate dihydrate (1993)
Magnesium acetate tetrahydrate (2035) Sodium chloride (0193)
Magnesium chloride 4.5-hydrate (1341) Sodium stearate (2058)
Magnesium chloride hexahydrate (0402) Sodium sulfite, anhydrous (0775)
Marbofloxacin for veterinary use (2233) Sodium sulfite heptahydrate (0776)
Mebendazole (0845) Somatropin (0951)
Mefenamic acid (1240) Somatropin concentrated solution (0950)
Menthol, racemic (0623) Somatropin for injection (0952)
Methacrylic acid - ethyl acrylate copolymer (1:1) (1128) Soya-bean oil, hydrogenated (1265)
Methotrexate (0560) Spirapril hydrochloride monohydrate (1766)
Methylprednisolone (0561) Stavudine (2130)
Methyl salicylate (0230) Sulfaguanidine (1476)
Methylthioninium chloride (1132) Sulfasalazine (0863)
Metronidazole benzoate (0934) Testosterone (1373)
Microcrystalline cellulose and carmellose sodium (2050) Tetrazepam (1738)
Minocycline hydrochloride dihydrate (1030) Thioridazine (2005)
Naproxen sodium (1702) Thioridazine hydrochloride (0586)
Nilutamide (2256) Tilidine hydrochloride hemihydrate (1767)
Nitrofurantoin (0101) all-rac- -Tocopherol (0692)
Norethisterone (0234) Tolfenamic acid (2039)
Orbifloxacin for veterinary use (2259) Trandolapril (2245)
Orciprenaline sulfate (1033) Tribenoside (1740)
Oxaliplatin (2017) Tryptophan (1272)
Oxprenolol hydrochloride (0628) Vancomycin hydrochloride (1058)
Oxycodone hydrochloride (1793) Verapamil hydrochloride (0573)
Papaverine hydrochloride (0102) Vincristine sulfate (0749)
Parnaparin sodium (1252) Vinorelbine tartrate (2107)
Penicillamine (0566) Xylometazoline hydrochloride (1162)
Pethidine hydrochloride (0420) Zinc acetate dihydrate (1482)
Phenylephrine (1035) Zinc acexamate (1279)
Phenylephrine hydrochloride (0632) Zinc gluconate (2164)
Pholcodine (0522) Zinc oxide (0252)
Pirenzepine dihydrochloride monohydrate (2001) Zinc stearate (0306)

xxi
Contents of the 7th Edition EUROPEAN PHARMACOPOEIA 7.0

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)) hydrochloride)

TEXTS DELETED FOR THE 7th EDITION

The following text is deleted as of 1 January 2011.
MONOGRAPHS
Monographs
Gallamine triethiodide (0181)

ERRATA
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)

xxii