ISO-15819-2008.pdf
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1、 Reference number ISO 15819:2008(E) ISO 2008 INTERNATIONAL STANDARD ISO 15819 First edition 2008-06-01 Cosmetics Analytical methods Nitrosamines: Detection and determination of N-nitrosodiethanolamine (NDELA) in cosmetics by HPLC-MS-MS Cosmtiques Mthodes analytiques Nitrosamines: Recherche et dosage
2、 des N-nitrosodithanolamines (NDELA) dans les produits cosmtiques par CLHP-SM-SM ISO 15819:2008(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobes licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedd
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5、m relating to it is found, please inform the Central Secretariat at the address given below. COPYRIGHT PROTECTED DOCUMENT ISO 2008 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, includi
6、ng photocopying and microfilm, without permission in writing from either ISO at the address below or ISOs member body in the country of the requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published
7、 in Switzerland ii ISO 2008 All rights reserved ISO 15819:2008(E) ISO 2008 All rights reserved iii Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally c
8、arried out through ISO technical 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 wor
9、k. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare Inter
10、national Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of th
11、e elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 15819 was prepared by Technical Committee ISO/TC 217, Cosmetics. -,-,- ISO 15819:2008(E) iv ISO 2008 All rights reserved Introduction Human exposure t
12、o 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 recognised as important to the preservation of human health. Among N-
13、nitrosamines, N-nitrosodiethanolamine (NDELA) has been recognised 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 chromatography/thermal energy analysis, high performance liquid chr
14、omatography (HPLC) coupled either with photolysis and colorimetric 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 artifactual formation of the analyte of interest and to
15、 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 for NDELA. INTERNATIONAL STANDARD ISO 15819:2008(E) ISO
16、2008 All rights reserved 1 Cosmetics Analytical methods Nitrosamines: Detection and determination of N-nitrosodiethanolamine (NDELA) in cosmetics by HPLC-MS-MS 1 Scope This International Standard describes a method for the detection and quantification of NDELA in cosmetics and raw materials used in
17、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 cosmetics. If a product has a possibility of either NDELA contamination from
18、ingredients or NDELA formation by the composition of ingredients, the method shall be applied for quantitative determination of NDELA. Accordingly the method would not be applied in routine testing of cosmetic products. Because of the large variety of cosmetic products within this field of applicati
19、on, this method might need to be adapted for certain matrices. Therefore, International Standards dedicated to alternative methods for testing nitrosamines in cosmetic products are being developed separately. Other methods can be employed provided that they are verified as to their detection of NDEL
20、A and validated in terms of recovery and quantification of the analyte. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced
21、 document (including any amendments) applies. ISO 3696:1987, Water for analytical laboratory use Specification and test methods 3 Principle Extraction of the nitrosamine NDELA in cosmetic samples is carried out with water in the presence of deuterated d8-NDELA used as internal standard. Clean-up is
22、performed either using solid phase extraction (SPE clean-up, see 6.3.1) with a C18 cartridge or liquidliquid extraction using dichloromethane (DCM clean-up, see 6.3.2) when the samples are not dispersible in water. The extracts are analysed by HPLC-MS- MS (high performance liquid chromatography coup
23、led with tandem mass spectrometric detection). NDELA quantification is done by comparing the ratio of the major fragment ions of NDELA and d8-NDELA with the calibration curve. Confirmation of the presence of NDELA is carried out by using the molecular ion and two diagnostic ions. -,-,- ISO 15819:200
24、8(E) 2 ISO 2008 All rights reserved 4 Reagents During the analysis, unless otherwise stated, use only reagents of recognized analytical grade and only distilled water or water of grade 1 in accordance with ISO 3696:1987. Solvent shall be of quality for HPLC analysis. 4.1 Methanol (MeOH), HPLC grade.
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