European Pharmacopoeia 8.0 34
EUROPEAN PHARMACOPOEIA 8.0 1.General
notices
the preamble to the speci?cation.The use of materials with different formulations,and the test methods and limits applied to them,are subject to agreement by the competent authority.The speci?cations for containers in general chapter 3.2have been developed for general application to containers of the stated category,but in view of the wide variety of containers available and possible new developments,the publication of a speci?cation does not exclude the use,in justi?ed circumstances,of containers that comply with other speci?cations,subject to agreement by the competent authority.Reference may be made within the monographs of the Pharmacopoeia to the de?nitions and speci?cations for containers provided in chapter 3.2.Containers .The general monographs for pharmaceutical dosage forms may,under the heading De?nition/Production,require the use of certain types of container;certain other monographs may,under the heading Storage,indicate the type of container that is recommended for use.1.4.MONOGRAPHS TITLES Monograph titles are in English and French in the respective versions and there is a Latin subtitle.RELATIVE ATOMIC AND MOLECULAR MASSES The relative atomic mass (A r )or the relative molecular mass (M r )is shown,as and where appropriate,at the beginning of each monograph.The relative atomic and molecular masses and the molecular and graphic formulae do not constitute analytical standards for the substances described.CHEMICAL ABSTRACTS SERVICE (CAS)REGISTRY NUMBER CAS registry numbers are included for information in monographs,where applicable,to provide convenient access to useful information for users.CAS Registry Number?is a registered trademark of the American Chemical Society.DEFINITION
Statements under the heading De?nition constitute an of?cial de?nition of the substance,preparation or other article that is the subject of the monograph.
Limits of content .Where limits of content are prescribed,they are those determined by the method described under Assay.
Herbal drugs .In monographs on herbal drugs,the de?nition indicates whether the subject of the monograph is,for example,the whole drug or the drug in powdered form.Where a monograph applies to the drug in several states,for example both to the whole drug and the drug in powdered form,the de?nition states this.
PRODUCTION
Statements under the heading Production draw attention to particular aspects of the manufacturing process but are not necessarily comprehensive.They constitute mandatory requirements for manufacturers,unless otherwise stated.They may relate,for example,to source materials;to the manufacturing process itself and its validation and control;to in-process testing;or to testing that is to be carried out by the manufacturer on the ?nal article,either on selected batches or on each batch prior to release.These statements cannot necessarily be veri?ed on a sample of the ?nal article by an independent analyst.The competent authority may establish that the instructions have been followed,for example,by examination of data received from the manufacturer,by inspection of manufacture or by testing appropriate samples.
The absence of a Production section does not imply that attention to features such as those referred to above is not required.
Choice of vaccine strain,Choice of vaccine composition .The Production section of a monograph may de?ne the characteristics of a vaccine strain or vaccine composition.Unless otherwise stated,test methods given for veri?cation of these characteristics are provided for information as examples of suitable methods.Subject to approval by the competent authority,other test methods may be used without validation against the method shown in the monograph.POTENTIAL ADULTERATION Due to the increasing number of fraudulent activities and cases of adulteration,information may be made available to https://www.sodocs.net/doc/258724286.html,ers to help detect adulterated materials (i.e.active substances,excipients,intermediate products,bulk products and ?nished products).To this purpose,a method for the detection of potential adulterants and relevant limits,together with a reminder that all stages of production and sourcing are subjected to a suitable quality system,may be included in this section of monographs on substances for which an incident has occurred or that present a risk of deliberate contamination.The frequency of testing by manufacturers or by users (e.g.manufacturers of intermediate products,bulk products and ?nished products,where relevant)depends on a risk assessment,taking into account the level of knowledge of the whole supply chain and national requirements.This section constitutes requirements for the whole supply chain,from manufacturers to users (e.g.manufacturers of intermediate products,bulk products and ?nished products,where relevant).The absence of this section does not imply
that attention to features such as those referred to above is not required.CHARACTERS
The statements under the heading Characters are not to be interpreted in a strict sense and are not requirements.Solubility .In statements of solubility in the Characters section,the terms used have the following signi?cance,referred to a temperature between 15°C and 25°C.Descriptive term Approximate volume of solvent in millilitres per gram of solute Very soluble less than 1Freely soluble from 1to 10Soluble from 10to 30Sparingly soluble from 30to 100Slightly soluble from 100to 1000Very slightly soluble from 1000to 10000Practically insoluble more than 10000The term ‘partly soluble’is used to describe a mixture where only some of the components dissolve.The term ‘miscible’is used to describe a liquid that is miscible in all proportions with the stated solvent.IDENTIFICATION Scope .The tests given in the Identi?cation section are not designed to give a full con?rmation of the chemical structure or composition of the product;they are intended to give con?rmation,with an acceptable degree of assurance,that the article conforms to the description on the label.First and second identi?cations .Certain monographs have subdivisions entitled ‘First identi?cation’and ‘Second identi?cation’.The test or tests that constitute the ‘First identi?cation’may be used in all circumstances.The test or tests that constitute the ‘Second identi?cation’may be used in pharmacies provided it can be demonstrated that the substance or preparation is fully traceable to a batch certi?ed to comply with all the other requirements of the monograph.Certain monographs give two or more sets of tests for the purpose of the ?rst identi?cation,which are equivalent General Notices (1)apply to all monographs and other texts 5