Style Guide of the European Pharmacopoeia

1 2017 European PharmacopoeiaPharmacop e Europ enneStyle Guide of the European PharmacopoeiaGuide de r daction de la Pharmacop e Europ enne Council of Europe, 67075 Strasbourg Cedex, France - 2017 All rights reservedMaking copies of this file for commercial purposes or posting this file on a website that is open to public consultation is strictly Pharmacopoeia Style Guide 2017 3 Table of contentsIntroduction 5 General notes 6 Name of product 6 Name of impurities 6 General chapters 7 Analytical procedures 7 Proper names 7 Trade names 7 Footnotes

2 7 Dimensions of apparatus 8 References to texts 8 Examples 8 Notes on drafting Style 9 Numbers 10 Significant figures in the expression of a limit 10 System of units 10 Writing of units 11 Writing of quantities and symbols 11 Mathematical formulae 12 Use of the terms Reference solution, Blank assay, Blank titration, Blank test, Compensation liquid 12 Reagents 13 Chemical Reference Substances (CRSs), Biological Reference Preparations (BRPs)

3 And International Reference Prepara-tions 14 Living organisms 14 Phrases frequently used in drafting identifications, tests and assays 15 Drafting of monographs 19 Monograph titles 19 English title 19 Latin title 19 Degree of hydration 21 Formulae, masses and CAS numbers 22 Graphic formula (for organic compounds) 22 Molecular formula 22 Relative atomic masses (Ar ) 22 Relative molecular masses (Mr )

4 23 CAS numbers 23 Definition 24 Production 26 Characters 28 Table des mati resIntroduction 5G n ralit s 6 Intitul du produit 6 Intitul des impuret s 6 Chapitres g n raux 7 Proc dures analytiques 7 Noms propres 7 Noms de marque 7 Notes de bas de page 7 Dimensions de l appareillage 8 Renvoi un texte 8 Exemples 8 Principes g n raux de r daction 9 Ecriture des nombres 10 Chiffres significatifs pour l expression des limites 10 Syst me d unit s 10 Ecriture des unit s 11 Ecriture des grandeurs et symboles

5 11 Expressions math matiques 12 Utilisation des expressions Solution t moin, Solution de r f rence, Dosage blanc, Titrage blanc, Essai blanc, Liquide de compensation 12R actifs 13 Substances chimiques de r f rence (SCR), pr parations bio-logiques de r f rence (PBR) et pr parations internationales de r f rence 14 Organismes vivants 14 Expressions couramment utilis es dans la r daction des identifications, des essais et du dosage. 15R daction des monographies 19 Titres des monographies 19 Titre fran ais 19 Titre latin 19 Degr d hydratation 21 Formules, masses et num ros CAS 22 Formule d velopp e (pour les substances organiques) 22 Formule brute 22 Masses atomiques relatives (Ar ) 22 Masses mol culaires relatives (Mr )

6 23 Num ros CAS 23D finition 24 Production 26 Caract res 28 4 Pharmacop e Europ enne Guide de r daction 2017 Physical characters 28 Solubility 29 Instability 30 Polymorphism 30 Physical constants 30 Others 30 Identification 31 Identification by physical methods 32 Identification by physico-chemical methods 35 Identification by chemical methods 39 Identification of hydrate 39 Tests 40 Physical and physico-chemical methods 43 Chemical methods 45 Chromatographic methods 46 Size-exclusion chromatography 62 Electrophoresis 63 Nuclear magnetic resonance spectrometry

7 66 Residual solvents 66 Organic impurities 66 Anions, cations, metals 67 Other tests 71 Biological methods 72 Special grade of a substance 73 Assay 75 Storage 78 Labelling 79 impurities 80 Functionality-related characteristics 83 Chromatograms 84 Glossary

8 86 Reagents 87 Annex 89 Quantitative expression of acceptance criteria in the test for related substances 89 Caract res organoleptiques 28 Solubilit 29 Instabilit 30 Polymorphisme 30 Constantes physiques 30 Autres 30 Identification 31 Identification par des proc d s physiques 32 Identification par des proc d s physicochimiques 35 Identification par voie chimique 39 Identification de l hydrate 39 Essai 40M thodes physiques et physicochimiques 43M thodes chimiques 45 Proc d s chromatographiques 46 Chromatographie d exclusion 62 Electrophor se 63 Spectrom trie de r sonance magn tique nucl aire 66 Solvants r siduels 66 Substances organiques

9 66 Anions, cations, m taux 67 Autres essais 71M thodes biologiques 72 Qualit s sp ciales d un produit 73 Dosage 75 Conservation 78 Etiquetage 79 Impuret s 80 Caract ristiques li es la fonctionnalit 83 Chromatogrammes 84 Glossaire 86R

10 Actifs 87 Annexe 89 Expression quantitative des crit res d acceptation pour l essai des substances apparent es 89 European Pharmacopoeia Style Guide 2017 5 Introduction Introduction INTRODUCTIONThe Style Guide has been produced to help all those involved in the preparation of monographs for the European Pharmacopoeia (Ph. Eur.): the groups of experts, secretaries of these groups, translators, national aim of the Style Guide is to provide the means of drafting clear unambiguous texts, with similar requirements presented in the same way in every monograph. A uniform Style is of great help in conveying information in an easily understandable and unambiguous manner. An analyst who has already carried out a test prescribed in the Ph.