EUROPEAN PHARMACOPOEIA 10.

0 Contents of the 10th Edition

IV. CONTENTS OF THE

10th EDITION
The 10th Edition consists of new texts as well as all current texts from the 9th Edition, some of which have been revised
or corrected.
Lists of the monographs and general chapters that, for the 10th Edition, are new, revised or corrected, or have had their titles or
chapter numbers changed, are given below.
The version date (for example 01/2020 for a text that is new or revised for the 10th Edition), completed by ‘corrected X.X’ if
a corrected version of the text has subsequently been published in Supplement X.X, and the reference number (4 digits
for monographs and 5 digits for general chapters) are specified above the title of each monograph and general chapter.
The version date, completed by ‘corrected X.X’ if appropriate, makes it possible to identify the successive versions of texts
in different editions.
The volume in which the current version was first published is stated in the Knowledge database on the EDQM website.
As of the 10th Edition, all revised or corrected parts of a text are indicated by vertical lines in the margin and horizontal lines in
the margin indicate where parts of a text have been deleted. Lines in the margin that were present in revised or corrected texts
in the previous edition are deleted with each new edition.
Corrected texts are to be taken into account as soon as possible and not later than the end of the month following the month of
publication of the volume. New and revised texts are to be taken into account not later than the implementation date.
A barcode is included at the start of each text, providing a link to further information on the text (e.g. the Knowledge database)
for smartphones and tablets with a camera and a barcode reader app.
In addition to corrections made to individual texts, the following decisions and systematic modifications have been made to
the texts of the European Pharmacopoeia for the 10th Edition.
– For texts not currently undergoing revision, the wording used in the calculation of percentage contents in the quantitative
expression of acceptance criteria in tests for related substances has been modified to specify the full name of the substance
(i.e. including counter-ions, hydrates etc.).
– Tests using diphosphorus pentoxide, predominantly tests for loss on drying, have been modified, where possible, to avoid
the use of this substance due to its toxicity.
– The names and descriptions of the reagents used to describe stationary phases for gas chromatography have been revised.
– ‘Tamper-proof ’ has been replaced by ‘tamper-evident’.
– Reference to general chapter 2.8.23. Microscopic examination of herbal drugs has been added when microscopic examination
is carried out using a powder with a non-standard sieve size.
– The terms ‘coarse’ and ‘coarsely’ have been deleted from ‘coarse powder (1400) (2.9.12)’ and ‘coarsely powdered herbal
drug (1400) (2.9.12)’.
– Results are expressed in per cent instead of per cent m/m in the tests Dry residue of extracts (2.8.16) and Loss on drying
of extracts (2.8.17).
Individual copies of texts published in this edition will not be supplied.
Subscribers to the current version (book or electronic) of the European Pharmacopoeia have access to an online archive version of
all obsolete editions and supplements of the European Pharmacopoeia in PDF format.
A list of new reagents published during the course of this edition is available under ‘Useful information’ in Pharmeuropa Online.

NEW TEXTS
The following texts appear for the first time in the European Pharmacopoeia. They will be implemented on 1 January 2020
at the latest.
GENERAL CHAPTERS Serratula coronata herb (2754)
2.6.35. Quantification and characterisation of residual Monographs
host-cell DNA
2.9.49. Powder flow properties by shear cell methods Benzydamine hydrochloride (2759)
Cocoa butter (2607)
2.9.52. Scanning electron microscopy
Dronedarone hydrochloride (3039)
3.3. Containers for human blood and blood components,
and materials used in their manufacture ; transfusion Octreotide (2414)
sets and materials used in their manufacture ; syringes Prasugrel hydrochloride (3040)
5.25. Process analytical technology Squalene (2805)
MONOGRAPHS Tapentadol hydrochloride (3035)
Vaccines for veterinary use Tetracaine (2909)
Infectious pancreatic necrosis vaccine (inactivated, Topiramate (2616)
oil-adjuvanted, injectable) for salmonids (3063) Vincamine (1800)
Herbal drugs and herbal drug preparations
Abelmoschi corolla (2827)

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REVISED TEXTS
The following texts have been technically revised since their last publication. They will be implemented on 1 January 2020
at the latest.
GENERAL CHAPTERS Diphtheria, tetanus, pertussis (acellular, component),
poliomyelitis (inactivated) and haemophilus type b conjugate
2.2.25. Absorption spectrophotometry, ultraviolet and visible
vaccine (adsorbed) (2065)
2.6.8. Pyrogens Influenza vaccine (surface antigen, inactivated, prepared in
2.6.33. Residual pertussis toxin cell cultures) (2149)
2.7.2. Microbiological assay of antibiotics Influenza vaccine (whole virion, inactivated, prepared in cell
cultures) (2308)
2.7.23. Numeration of CD34/CD45+ cells in haematopoietic Pertussis vaccine (acellular, component, adsorbed) (1356)
products
Pertussis vaccine (acellular, co-purified, adsorbed) (1595)
2.7.35. Immunonephelometry for vaccine component assay
Poliomyelitis vaccine (oral) (0215)
2.8.25. High-performance thin-layer chromatography of Yellow fever vaccine (live) (0537)
herbal drugs and herbal drug preparations
Vaccines for veterinary use
2.9.1. Disintegration of tablets and capsules
Enteric redmouth disease vaccine (inactivated) for rainbow
2.9.20. Particulate contamination : visible particles trout (1950)
3.1.13. Plastic additives Immunosera for human use
3.3.1. Botulinum antitoxin (0085)
Materials for containers for human blood and blood
components Herbal drugs and herbal drug preparations
3.3.2. Materials based on plasticised poly(vinyl chloride) for Indigo plant leaf (2727)
containers for human blood and blood components Monographs
3.3.3. Materials based on plasticised poly(vinyl chloride) for Alfacalcidol (1286)
tubing used in sets for the transfusion of blood and Aluminium magnesium silicate (1388)
blood components
Anticoagulant and preservative solutions for human blood
3.3.4. Sterile plastic containers for human blood and blood (0209)
components
Apomorphine hydrochloride hemihydrate (0136)
3.3.5. Empty sterile containers of plasticised poly(vinyl
chloride) for human blood and blood components Arachis oil, hydrogenated (1171)
3.3.6. Benserazide hydrochloride (1173)
Sterile containers of plasticised poly(vinyl chloride)
for human blood containing anticoagulant solution Biotin (1073)
3.3.7. Sets for the transfusion of blood and blood Boldine (2971)
components Borage (starflower) oil, refined (2105)
3.3.8. Sterile single-use plastic syringes Caffeine (0267)
4. Reagents Caffeine monohydrate (0268)
Candesartan cilexetil (2573)
5.3. Statistical analysis of results of biological assays and
Carmellose sodium (0472)
tests
5.8. Pharmacopoeial harmonisation Carmellose sodium, low-substituted (1186)
Carmustine (1187)
5.21. Chemometric methods applied to analytical data
Castor oil, hydrogenated (1497)
5.22. Names of herbal drugs used in traditional Chinese Castor oil, refined (2367)
medicine
5.24. Castor oil, virgin (0051)
Chemical imaging
Cellulose, microcrystalline (0316)
MONOGRAPHS Cetyl palmitate (1906)
Dosage forms Chlorpromazine hydrochloride (0475)
Powders, oral (1165) Chlortalidone (0546)
Cholesterol for parenteral use (2397)
Vaccines for human use
Cod-liver oil (type A) (1192)
Diphtheria, tetanus and pertussis (acellular, component)
vaccine (adsorbed) (1931) Cod-liver oil (type B) (1193)
Diphtheria, tetanus and pertussis (acellular, component) Copovidone (0891)
vaccine (adsorbed, reduced antigen(s) content) (2764) Cottonseed oil, hydrogenated (1305)
Diphtheria, tetanus, pertussis (acellular, component) and Croscarmellose sodium (0985)
haemophilus type b conjugate vaccine (adsorbed) (1932) Desipramine hydrochloride (0481)
Diphtheria, tetanus, pertussis (acellular, component) and Diacerein (2409)
hepatitis B (rDNA) vaccine (adsorbed) (1933) Diethylene glycol palmitostearate (1415)
Diphtheria, tetanus, pertussis (acellular, component) and Ethylene glycol monopalmitostearate (1421)
poliomyelitis (inactivated) vaccine (adsorbed) (1934) Evening primrose oil, refined (2104)
Diphtheria, tetanus, pertussis (acellular, component) and Fenoterol hydrobromide (0901)
poliomyelitis (inactivated) vaccine (adsorbed, reduced
antigen(s) content) (2329) Fish oil, rich in omega-3 acids (1912)
Diphtheria, tetanus, pertussis (acellular, component), hepatitis Follitropin (2285)
B (rDNA), poliomyelitis (inactivated) and haemophilus type Follitropin concentrated solution (2286)
b conjugate vaccine (adsorbed) (2067) Galactose (1215)

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Galantamine hydrobromide (2366) Phenylpropanolamine hydrochloride (0683)

Gelatin (0330) Phytomenadione, racemic (3011)
Glycerol dibehenate (1427) Propranolol hydrochloride (0568)
Glycerol distearate (1428) Propyl gallate (1039)
Glycerol monostearate 40-55 (0495) Propylene glycol monopalmitostearate (1469)
Gonadotrophin, chorionic (0498) Protamine sulfate (0569)
Hard fat (0462) Pyridoxine hydrochloride (0245)
Hard fat with additives (2731) Safflower oil, refined (2088)
Heparin calcium (0332) Sodium starch glycolate (type A) (0983)
Heparin sodium (0333) Sodium starch glycolate (type B) (0984)
Human measles immunoglobulin (0397) Sodium starch glycolate (type C) (1566)
Human plasma for fractionation (0853) Solutions for organ preservation (1264)
Human plasma (pooled and treated for virus inactivation) Soya-bean oil, hydrogenated (1265)
(1646) Soya-bean oil, refined (1473)
Imidacloprid for veterinary use (2924) Squalane (1630)
Infliximab concentrated solution (2928) Sucralfate (1796)
Irbesartan (2465) Terbutaline sulfate (0690)
Lauromacrogol 400 (2046) Tilidine hydrochloride hemihydrate (1767)
Levodropropizine (1535) Triglycerides, medium-chain (0868)
Losartan potassium (2232) Urofollitropin (0958)
Macrogol 15 hydroxystearate (2052) Urokinase (0695)
Macrogol 30 dipolyhydroxystearate (2584) Valsartan (2423)
Mesterolone (1730) Vigabatrin (2305)
Olmesartan medoxomil (2600) Vinorelbine tartrate (2107)
Oxytetracycline hydrochloride (0198) Wheat starch (0359)
Palmitic acid (1904) Wheat-germ oil, refined (1379)
Penicillamine (0566) Wheat-germ oil, virgin (1480)

CORRECTED TEXTS
The following texts have been corrected for the 10th Edition and specify ‘corrected 10.0’ above the title. These corrections are
to be taken into account as soon as possible and not later than 31 August 2019 (the end of the month following the month
of publication of the 10th Edition).
GENERAL CHAPTERS 3.2. Containers
1. General notices 5.1.2. Biological indicators and related microbial
2.2.5. Relative density preparations used in the manufacture of sterile
products
2.2.29. Liquid chromatography 5.1.6. Alternative methods for control of microbiological
2.2.31. Electrophoresis quality
2.4.23. Sterols in fatty oils 5.2.12. Raw materials of biological origin for the production
of cell-based and gene therapy medicinal products
2.4.25. Ethylene oxide and dioxan 5.9. Polymorphism
2.4.26. N,N-Dimethylaniline 5.10. Control of impurities in substances for pharmaceutical
2.4.32. Total cholesterol in oils rich in omega-3 acids use
5.12. Reference standards
2.5.19. O-Acetyl in polysaccharide vaccines
5.15. Functionality-related characteristics of excipients
2.5.37. Methyl, ethyl and isopropyl methanesulfonate in
methanesulfonic acid 5.16. Crystallinity
2.5.38. Methyl, ethyl and isopropyl methanesulfonate in
active substances MONOGRAPHS
2.5.39. Methanesulfonyl chloride in methanesulfonic acid General monographs
2.5.40. Methyl, ethyl and isopropyl toluenesulfonate in active Chemical precursors for radiopharmaceutical preparations
substances (2902)
2.5.41. Methyl, ethyl and isopropyl benzenesulfonate in Immunosera for human use, animal (0084)
active substances
2.7.8. Immunosera for veterinary use (0030)
Assay of tetanus vaccine (adsorbed)
Live biotherapeutic products for human use (3053)
2.8.9. Residue on evaporation of essential oils Vaccines for human use (0153)
2.9.10. Ethanol content Vaccines for veterinary use (0062)
2.9.11. Test for methanol and 2-propanol Dosage forms
3.1.14. Materials based on plasticised poly(vinyl chloride) Ear preparations (0652)
for containers for aqueous solutions for intravenous Eye preparations (1163)
infusion Intramammary preparations for veterinary use (0945)

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Liquid preparations for cutaneous application (0927) Mastic (1876)

Nasal preparations (0676) Myrrh tincture (1877)
Parenteral preparations (0520) Nutmeg oil (1552)
Rectal preparations (1145) Opium tincture, standardised (1841)
Semi-solid preparations for cutaneous application (0132) Oregano (1880)
Vaginal preparations (1164) Pepper (2477)
Vaccines for human use Roselle (1623)
Anthrax vaccine for human use (adsorbed, prepared from Round amomum fruit (2555)
culture filtrates) (2188) Sage tincture (1889)
Diphtheria and tetanus vaccine (adsorbed) (0444) Saw palmetto extract (2579)
Diphtheria and tetanus vaccine (adsorbed, reduced antigen(s) Saw palmetto fruit (1848)
content) (0647) Star anise (1153)
Diphtheria, tetanus and pertussis (whole cell) vaccine Stramonium, prepared (0247)
(adsorbed) (0445)
Sweet orange oil (1811)
Diphtheria, tetanus and poliomyelitis (inactivated) vaccine
(adsorbed, reduced antigen(s) content) (2328) Thyme oil, thymol type (1374)
Diphtheria vaccine (adsorbed) (0443) Turmeric rhizome (2543)
Diphtheria vaccine (adsorbed, reduced antigen content) Homoeopathic preparations
(0646) Homoeopathic preparations : introduction (90006)
Influenza vaccine (live, nasal) (2772) Agaricus phalloides for homoeopathic preparations (2290)
Influenza vaccine (split virion, inactivated) (0158) Anacardium for homoeopathic preparations (2094)
Influenza vaccine (surface antigen, inactivated) (0869) Belladonna for homoeopathic preparations (2489)
Influenza vaccine (surface antigen, inactivated, virosome) Cocculus for homoeopathic preparations (2486)
(2053) Hydrastis canadensis for homoeopathic preparations (2500)
Influenza vaccine (whole virion, inactivated) (0159) Ignatia for homoeopathic preparations (2513)
Measles, mumps, rubella and varicella vaccine (live) (2442) Magnesium phosphoricum for homoeopathic preparations
Pneumococcal polysaccharide vaccine (0966) (2505)
Poliomyelitis vaccine (inactivated) (0214) Nux-vomica for homoeopathic preparations (2514)
Shingles (herpes zoster) vaccine (live) (2418) Staphysagria for homoeopathic preparations (2289)
Tetanus vaccine (adsorbed) (0452) Monographs
Typhoid polysaccharide vaccine (1160) N-Acetyltyrosine (1384)
Varicella vaccine (live) (0648) Alimemazine hemitartrate (2650)
Immunosera for human use Almagate (2010)
Viper venom antiserum, European (0145) Alprazolam (1065)
Radiopharmaceutical preparations and starting materials Alprenolol hydrochloride (0876)
for radiopharmaceutical preparations Aluminium hydroxide, hydrated, for adsorption (1664)
Choline ([11C]methyl) injection (2462) Aluminium stearate (1663)
Copper tetramibi tetrafluoroborate for radiopharmaceutical Alverine citrate (2156)
preparations (2547) Amantadine hydrochloride (0463)
Fluorocholine (18F) injection (2793) Amikacin sulfate (1290)
Sutures for human use 4-Aminobenzoic acid (1687)
Sutures for human use : introduction (90004) Amoxicillin sodium (0577)
Sutures, sterile non-absorbable (0324) Amphotericin B (1292)
Herbal drugs and herbal drug preparations Ampicillin sodium (0578)
Herbal drugs : introduction (90029) Anti-T lymphocyte immunoglobulin for human use, animal
Achyranthes bidentata root (2999) (1928)
Akebia stem (2472) Aprotinin (0580)
Aloes dry extract, standardised (0259) Aprotinin concentrated solution (0579)
Amomum fruit (2554) Arginine hydrochloride (0805)
Artichoke leaf (1866) Aripiprazole (2617)
Belladonna, prepared (0222) Articaine hydrochloride (1688)
Capsicum soft extract, standardised (2529) Atazanavir sulfate (2898)
Cassia oil (1496) Atropine (2056)
Cinnamon bark oil, Ceylon (1501) Atropine sulfate (0068)
Fennel, bitter (0824) Azelastine hydrochloride (1633)
Fennel, sweet (0825) Bacitracin (0465)
Gentian tincture (1870) Bacitracin zinc (0466)
Ginger (1522) Benzalkonium chloride (0372)
Goldenseal rhizome (1831) Benzalkonium chloride solution (0371)
Juniper oil (1832) Benzyl alcohol (0256)
Long pepper (2453) Benzyl benzoate (0705)
Mandarin oil (2355) Benzylpenicillin (benzathine) tetrahydrate (0373)

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Benzylpenicillin potassium (0113) Codeine phosphate hemihydrate (0074)

Benzylpenicillin (procaine) monohydrate (0115) Colestyramine (1775)
Benzylpenicillin sodium (0114) Colistimethate sodium (0319)
Biperiden hydrochloride (1074) Colistin sulfate (0320)
Bismuth subsalicylate (1495) Crospovidone (0892)
Bleomycin sulfate (0976) Cyclizine hydrochloride (1092)
Botulinum toxin type A for injection (2113) Cysteine hydrochloride monohydrate (0895)
Botulinum toxin type B for injection (2581) Cytarabine (0760)
Brimonidine tartrate (2760) Dacarbazine (1691)
Bromhexine hydrochloride (0706) Danaparoid sodium (2090)
Brompheniramine maleate (0977) Daunorubicin hydrochloride (0662)
Bupivacaine hydrochloride (0541) Deferiprone oral solution (2987)
Buserelin (1077) Deferoxamine mesilate (0896)
Calcitonin (salmon) (0471) Demeclocycline hydrochloride (0176)
Calcium folinate hydrate (0978) Desflurane (1666)
Calcium glucoheptonate (1399) Desloratadine (2570)
Calcium levofolinate hydrate (1606) Desmopressin (0712)
Captopril (1079) Detomidine hydrochloride for veterinary use (1414)
Carbimazole (0884) Dexchlorpheniramine maleate (1196)
Cefalotin sodium (0987) Dibutyl phthalate (0762)
Cefamandole nafate (1402) Diclofenac potassium (1508)
Cefapirin sodium (1650) Diclofenac sodium (1002)
Cefazolin sodium (0988) Dicloxacillin sodium (0663)
Cefepime dihydrochloride monohydrate (2126) Dicycloverine hydrochloride (1197)
Cefoperazone sodium (1404) Diethyl phthalate (0897)
Cefotaxime sodium (0989) Diethylene glycol monoethyl ether (1198)
Cefoxitin sodium (0990) Dihydrostreptomycin sulfate for veterinary use (0485)
Ceftazidime pentahydrate (1405) Dimetindene maleate (1417)
Ceftazidime pentahydrate with sodium carbonate for injection Docusate sodium (1418)
(2344) Doxorubicin hydrochloride (0714)
Ceftriaxone sodium (0991) Doxycycline hyclate (0272)
Cefuroxime axetil (1300) Doxycycline monohydrate (0820)
Cefuroxime sodium (0992) Doxylamine hydrogen succinate (1589)
Cetostearyl alcohol (0702) Duloxetine hydrochloride (2594)
Cetostearyl alcohol (type A), emulsifying (0801) Edrophonium chloride (2106)
Cetostearyl alcohol (type B), emulsifying (0802) Enalapril maleate (1420)
Cetyl alcohol (0540) Enilconazole for veterinary use (1720)
Chloramphenicol (0071) Enrofloxacin for veterinary use (2229)
Chloramphenicol palmitate (0473) Epirubicin hydrochloride (1590)
Chloramphenicol sodium succinate (0709) Erythromycin lactobionate (1098)
Chlorobutanol (0382) Erythropoietin concentrated solution (1316)
Chlorobutanol hemihydrate (0383) Estrogens, conjugated (1512)
Chlorocresol (0384) Ethacridine lactate monohydrate (1591)
Chlortetracycline hydrochloride (0173) Ethanol (96 per cent) (1317)
Cholesterol (0993) Ethanol, anhydrous (1318)
Ciclopirox (1407) Ethylcellulose (0822)
Ciclosporin (0994) Etofenamate (1513)
Cilastatin sodium (1408) Eugenol (1100)
Cladribine (2174) Everolimus (2918)
Clemastine fumarate (1190) Felypressin (1634)
Clindamycin phosphate (0996) Fentanyl citrate (1103)
Clioquinol (2111) Fenticonazole nitrate (1211)
Clodronate disodium tetrahydrate (1777) Filgrastim concentrated solution (2206)
Clofibrate (0318) Filgrastim injection (2848)
Clonidine hydrochloride (0477) Flucloxacillin sodium (0668)
Clopidogrel besilate (2790) Folic acid hydrate (0067)
Clopidogrel hydrochloride (2791) Foscarnet sodium hexahydrate (1520)
Clopidogrel hydrogen sulfate (2531) Fosfomycin sodium (1329)
Cloxacillin sodium (0661) Framycetin sulfate (0180)
Codeine hydrochloride dihydrate (1412) Fulvestrant (2443)
Codeine monohydrate (0076) Gadobutrol monohydrate (2735)

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Gadodiamide hydrate (2225) Magnesium aspartate dihydrate (1445)

Gemcitabine hydrochloride (2306) Magnesium stearate (0229)
Gentamicin sulfate (0331) Maize starch (0344)
Glipizide (0906) Meldonium dihydrate (2624)
Glucagon, human (1635) Menadione (0507)
Glycerol (0496) Mepivacaine hydrochloride (1242)
Glycerol (85 per cent) (0497) Mepyramine maleate (0278)
Glycerol monocaprylate (2213) Meropenem trihydrate (2234)
Glycerol monocaprylocaprate (2392) Metacresol (2077)
Gonadorelin acetate (0827) Methadone hydrochloride (0408)
Gonadotrophin, equine serum, for veterinary use (0719) Methanol (1989)
Gramicidin (0907) Methyl salicylate (0230)
Guaiacol (1978) Methylcellulose (0345)
Halothane (0393) Methylene chloride (0932)
Heparins, low-molecular-mass (0828) N-Methylpyrrolidone (1675)
Heptaminol hydrochloride (1980) Metoclopramide hydrochloride monohydrate (0674)
Histidine hydrochloride monohydrate (0910) Mianserin hydrochloride (0846)
Human coagulation factor VIIa (rDNA) concentrated solution Minocycline hydrochloride dihydrate (1030)
(2534) Molgramostim concentrated solution (1641)
Human coagulation factor IX (rDNA) concentrated solution Naftidrofuryl hydrogen oxalate (1594)
(2522) Nandrolone decanoate (1992)
Hyaluronidase (0912) Naphazoline hydrochloride (0730)
Hydroxychloroquine sulfate (2849) Naphazoline nitrate (0147)
Hydroxyethylcellulose (0336) Neomycin sulfate (0197)
Hydroxypropylcellulose (0337) Neostigmine bromide (0046)
Hydroxypropylcellulose, low-substituted (2083) Neostigmine metilsulfate (0626)
Hyoscyamine sulfate (0501) Netilmicin sulfate (1351)
Hypromellose (0348) Nevirapine hemihydrate (2479)
Imipenem monohydrate (1226) Nicardipine hydrochloride (2776)
Insulin aspart (2084) Norflurane (2257)
Insulin, bovine (1637) Nystatin (0517)
Insulin glargine (2571) Octyldodecanol (1136)
Insulin, human (0838) Oleyl alcohol (2073)
Insulin lispro (2085) Olsalazine sodium (1457)
Insulin, porcine (1638) Orphenadrine citrate (1759)
Insulin preparations, injectable (0854) Orphenadrine hydrochloride (1760)
Interferon alfa-2 concentrated solution (1110) Oseltamivir phosphate (2422)
Interferon beta-1a concentrated solution (1639) Oxacillin sodium monohydrate (2260)
Interferon gamma-1b concentrated solution (1440) Oxeladin hydrogen citrate (1761)
Iohexol (1114) Oxolinic acid (1353)
Iopamidol (1115) Oxytetracycline dihydrate (0199)
Irinotecan hydrochloride trihydrate (2675) Oxytocin (0780)
Isoprenaline sulfate (0502) Oxytocin concentrated solution (0779)
Isopropyl alcohol (0970) Paclitaxel (1794)
Isopropyl myristate (0725) Papaverine hydrochloride (0102)
Isopropyl palmitate (0839) Pemetrexed disodium heptahydrate (2637)
Isosorbide dinitrate, diluted (1117) Permethrin (25:75) (1762)
Isoxsuprine hydrochloride (1119) Phentolamine mesilate (1138)
Kanamycin acid sulfate (0033) Phytosterol (1911)
Kanamycin monosulfate (0032) Piperacillin sodium (1168)
Labetalol hydrochloride (0923) Piperazine hydrate (0425)
Lactose (1061) Poloxamers (1464)
Leuprorelin (1442) Polymyxin B sulfate (0203)
Levocabastine hydrochloride (1484) Polyoxypropylene stearyl ether (2602)
Lincomycin hydrochloride (0583) Polysorbate 80 (0428)
Lomustine (0928) Poly(vinyl acetate) (1962)
Loratadine (2124) Poly(vinyl acetate) dispersion 30 per cent (2152)
Lynestrenol (0558) Potassium clavulanate (1140)
Macrogol isotridecyl ether (2730) Potassium dihydrogen phosphate (0920)
Macrogol lauryl ether (1124) Pramipexole dihydrochloride monohydrate (2416)
Macrogol poly(vinyl alcohol) grafted copolymer (2523) Praziquantel (0855)

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Propanol (2036) Tacalcitol monohydrate (2272)

Propofol (1558) Tacrolimus monohydrate (2244)
Protirelin (1144) Tadalafil (2606)
Pyrantel embonate (1680) Tamsulosin hydrochloride (2131)
Pyridostigmine bromide (1255) Teriparatide (2829)
Pyrrolidone (2180) Terpin monohydrate (2940)
Rabeprazole sodium (2868) Testosterone decanoate (1736)
Rabeprazole sodium hydrate (2331) Testosterone enantate (1048)
Raltegravir potassium (2887) Testosterone isocaproate (1737)
Ranitidine hydrochloride (0946) Tetracycline hydrochloride (0210)
Remifentanil hydrochloride (2644) Tetryzoline hydrochloride (2101)
Reserpine (0528) Thiamazole (1706)
Rifamycin sodium (0432) Thiamine hydrochloride (0303)
Rilmenidine dihydrogen phosphate (2020) Thiamine nitrate (0531)
Rivastigmine hydrogen tartrate (2630) Thiocolchicoside crystallised from ethanol (2896)
Rupatadine fumarate (2888) Thiocolchicoside hydrate (2814)
Saccharin (0947) Thiomersal (1625)
Saccharin sodium (0787) Tianeptine sodium (2022)
Salmeterol xinafoate (1765) Tiapride hydrochloride (1575)
Sertraline hydrochloride (1705) Ticarcillin sodium (0956)
Sevoflurane (2269) Tigecycline (2825)
Sildenafil citrate (2270) Tizanidine hydrochloride (2578)
Sitagliptin phosphate monohydrate (2778) Tobramycin (0645)
Sitagliptin tablets (2927) all-rac-α-Tocopherol (0692)
Sodium aminosalicylate dihydrate (1993) RRR-α-Tocopherol (1256)
Sodium aurothiomalate (1994) all-rac-α-Tocopheryl acetate (0439)
Sodium cetostearyl sulfate (0847) RRR-α-Tocopheryl acetate (1257)
Sodium cyclamate (0774) α-Tocopheryl acetate concentrate (powder form) (0691)
Sodium hyaluronate (1472) DL-α-Tocopheryl hydrogen succinate (1258)
Sodium (S)-lactate solution (2033) RRR-α-Tocopheryl hydrogen succinate (1259)
Sodium phenylbutyrate (2183) Tolterodine tartrate (2781)
Sodium propionate (2041) Tosylchloramide sodium (0381)
Sodium stearyl fumarate (1567) Tributyl acetylcitrate (1770)
Solifenacin succinate (2779) Tri-n-butyl phosphate (1682)
Somatostatin (0949) Triethyl citrate (1479)
Somatropin (0951) Trimebutine maleate (2182)
Somatropin concentrated solution (0950) Trimetazidine dihydrochloride (1741)
Somatropin for injection (0952) Trimethoprim (0060)
Somatropin solution for injection (2370) Trolamine (1577)
Spectinomycin dihydrochloride pentahydrate (1152) Troxerutin (2133)
Spectinomycin sulfate tetrahydrate for veterinary use (1658) Tuberculin purified protein derivative, avian (0535)
Spiramycin (0293) Tuberculin purified protein derivative, bovine (0536)
Starch, hydroxypropyl (2165) Tylosin for veterinary use (1273)
Starch, hydroxypropyl, pregelatinised (2645) Tylosin phosphate for veterinary use (2802)
Starches, hydroxyethyl (1785) Tylosin tartrate for veterinary use (1274)
Stearyl alcohol (0753) Vancomycin hydrochloride (1058)
Streptokinase concentrated solution (0356) Vardenafil hydrochloride trihydrate (2782)
Streptomycin sulfate (0053) Vecuronium bromide (1769)
Sufentanil citrate (1269) Vinblastine sulfate (0748)
Sulbactam sodium (2209) Vincristine sulfate (0749)
Sulfadimethoxine sodium for veterinary use (2745) Vindesine sulfate (1276)
Sulfaguanidine (1476) Voriconazole (2576)
Sulfamerazine (0358) Wool alcohols (0593)
Sulfobutylbetadex sodium (2804) Wool fat (0134)
Sultamicillin (2211) Wool fat, hydrogenated (0969)
Sultamicillin tosilate dihydrate (2212) Xylitol (1381)
Sumatriptan succinate (1573) Ziprasidone mesilate trihydrate (2649)

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Contents of the 10th Edition EUROPEAN PHARMACOPOEIA 10.0

TEXTS WHOSE TITLE HAS CHANGED

The titles of the following texts have been changed for the 10th Edition.
GENERAL CHAPTERS
2.6.33. Residual pertussis toxin (previously Residual pertussis toxin and irreversibility of pertussis toxoid)

MONOGRAPHS Herbal drugs and herbal drug preparations

Vaccines for veterinary use Herbal drugs : introduction (90029) (previously Introduction)
Enteric redmouth disease vaccine (inactivated) for rainbow Homoeopathic preparations
trout (1950) (previously Yersiniosis vaccine (inactivated) for Homoeopathic preparations : introduction (90006) (previously
salmonids) Introduction)
Sutures for human use
Sutures for human use : introduction (90004) (previously
Introduction)

TEXTS WHOSE NUMBERING HAS CHANGED

The numbering of the following texts has been changed for the 10th Edition following the modification of the structure of section 3
and the creation of chapter 3.3. Containers for human blood and blood components, and materials used in their manufacture ;
transfusion sets and materials used in their manufacture ; syringes. Chapter 3.3 contains the following texts, which were
previously in chapters 3.1. Materials used for the manufacture of containers and 3.2. Containers.
GENERAL CHAPTERS
3.3.1. Materials for containers for human blood and blood components (previously 3.1.1)
3.3.2. Materials based on plasticised poly(vinyl chloride) for containers for human blood and blood components (previously
3.1.1.1)
3.3.3. Materials based on plasticised poly(vinyl chloride) for tubing used in sets for the transfusion of blood and blood
components (previously 3.1.1.2)
3.3.4. Sterile plastic containers for human blood and blood components (previously 3.2.3)
3.3.5. Empty sterile containers of plasticised poly(vinyl chloride) for human blood and blood components (previously 3.2.4)
3.3.6. Sterile containers of plasticised poly(vinyl chloride) for human blood containing anticoagulant solution (previously
3.2.5)
3.3.7. Sets for the transfusion of blood and blood components (previously 3.2.6)
3.3.8. Sterile single-use plastic syringes (previously 3.2.8)

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