BS ISO 15819-2014 Cosmetics Analytical methods Nitrosamines Detection and determination of N-nitrosodiethanolamine (NDELA) in cosmetics by HPLC-MS-MS《化妆品 分析方法 亚硝胺 使用液相色谱-质谱串联(HPLC-.pdf
《BS ISO 15819-2014 Cosmetics Analytical methods Nitrosamines Detection and determination of N-nitrosodiethanolamine (NDELA) in cosmetics by HPLC-MS-MS《化妆品 分析方法 亚硝胺 使用液相色谱-质谱串联(HPLC-.pdf》由会员分享,可在线阅读,更多相关《BS ISO 15819-2014 Cosmetics Analytical methods Nitrosamines Detection and determination of N-nitrosodiethanolamine (NDELA) in cosmetics by HPLC-MS-MS《化妆品 分析方法 亚硝胺 使用液相色谱-质谱串联(HPLC-.pdf(22页珍藏版)》请在麦多课文档分享上搜索。
1、BSI Standards PublicationBS ISO 15819:2014Cosmetics Analyticalmethods Nitrosamines:Detection and determinationof N-nitrosodiethanolamine(NDELA) in cosmetics by HPLC-MS-MSBS ISO 15819:2014 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of ISO 15819:2014. Itsupersedes
2、BS ISO 15819:2008 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CW/217, Cosmetics.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions
3、 of a contract. Users are responsible for its correctapplication. The British Standards Institution 2014. Published by BSI StandardsLimited 2014ISBN 978 0 580 82029 8ICS 71.100.70Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under
4、 the authority of theStandards Policy and Strategy Committee on 30 November 2014.Amendments issued since publicationDate Text affectedBS ISO 15819:2014 ISO 2014Cosmetics Analytical methods Nitrosamines: Detection and determination of N-nitrosodiethanolamine (NDELA) in cosmetics by HPLC-MS-MSCosmtiqu
5、es Mthodes analytiques Nitrosamines: Recherche et dosage de la N-nitrosodithanolamine (NDELA) dans les produits cosmtiques par CLHP-SM-SMINTERNATIONAL STANDARDISO15819Second edition2014-10-15Reference numberISO 15819:2014(E)BS ISO 15819:2014ISO 15819:2014(E)ii ISO 2014 All rights reservedCOPYRIGHT P
6、ROTECTED DOCUMENT ISO 2014All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission. P
7、ermission can be requested from either ISO at the address below or ISOs member body in the country of the requester.ISO copyright officeCase postale 56 CH-1211 Geneva 20Tel. + 41 22 749 01 11Fax + 41 22 749 09 47E-mail copyrightiso.orgWeb www.iso.orgPublished in SwitzerlandBS ISO 15819:2014ISO 15819
8、:2014(E)Contents PageForeword vIntroduction vi1 Scope . 12 Normative references 13 Principle 14 Reagents 25 Apparatus . 26 Sample preparation and conservation 36.1 General . 36.2 Standard solutions preparation . 36.3 Sample preparation 47 Procedure. 57.1 General . 57.2 Chromatographic conditions 57.
9、3 HPLC-MS-MS conditions . 68 Calculation of results . 78.1 Determination of the R value 78.2 Calibration curve . 78.3 Validity check procedure and its criteria . 78.4 Calculation of concentrations . 79 Test report . 8Annex A (informative) Examples of a calibration curve and of chromatograms 9Bibliog
10、raphy .11 ISO 2014 All rights reserved iiiBS ISO 15819:2014ISO 15819:2014(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO t
11、echnical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates clos
12、ely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria n
13、eeded for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives). Attention is drawn to the possibility that some of the elements of this document may be the subject of pate
14、nt rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents). Any trade name used
15、 in this document is information given for the convenience of users and does not constitute an endorsement.For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barr
16、iers to Trade (TBT) see the following URL: Foreword - Supplementary informationThe committee responsible for this document is ISO/TC 217, Cosmetics.This second edition cancels and replaces the first edition (ISO 15819:2008), which has been technically revised.iv ISO 2014 All rights reservedBS ISO 15
17、819:2014ISO 15819:2014(E)IntroductionHuman exposure to N-nitrosamines can occur through diverse sources such as environment, food, or personal care products. As a result of their perceived carcinogenic potential on several animal species, minimization of exposure to N-nitrosamines is recognized as i
18、mportant to the preservation of human health. Among N-nitrosamines, N-nitrosodiethanolamine (NDELA) has been recognized as a potential contaminant of cosmetics.In this context, several analytical methods have been developed to detect and determine its presence in cosmetics, such as gas chromatograph
19、y/thermal energy analysis, high performance liquid chromatography (HPLC) coupled either with photolysis and colourimetric quantification or with mass spectrometry (MS) determination. This latter method uses advanced technology to ensure the maximum specificity towards NDELA, to minimize the risk of
20、artefactual formation of the analyte of interest and to allow precise quantification.This analytical method uses high performance liquid chromatography coupled with mass spectrometry to separate and detect trace levels of NDELA from a cosmetic ingredient or product matrix with maximum specificity fo
21、r NDELA. ISO 2014 All rights reserved vBS ISO 15819:2014BS ISO 15819:2014Cosmetics Analytical methods Nitrosamines: Detection and determination of N-nitrosodiethanolamine (NDELA) in cosmetics by HPLC-MS-MS1 ScopeThis International Standard describes a method for the detection and quantification of N
22、-nitrosodiethanolamine (NDELA) in cosmetics and raw materials used in cosmetics.This method is not applicable to the detection and/or quantification of nitrosamines other than NDELA nor to the detection and/or quantification of NDELA in products other than cosmetics or raw materials used in cosmetic
23、s.If a product has a possibility of either NDELA contamination from ingredients or NDELA formation by the composition of ingredients, the method is intended to be applied for quantitative determination of NDELA. Accordingly, the method does not apply to routine testing of cosmetic products. Because
24、of the large variety of cosmetic products within this field of application, this method might need to be adapted for certain matrices (refer to ISO 12787).Therefore, International Standards dedicated to alternative methods for testing nitrosamines in cosmetic products are being developed separately.
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