Annex to the Accreditation Certificate D-RM according to ISO Guide 34:2009 and DIN EN ISO/IEC 17025:2005

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1 Deutsche Akkreditierungsstelle GmbH Annex to the Accreditation Certificate D-RM according to ISO Guide 34:2009 and DIN EN ISO/IEC 17025:2005 Period of validity: to date of issue: Holder of certificate: LGC GmbH on the sites Im Biotechnologiepark TGZ II, Luckenwalde Louis-Pasteur-Straße 30, Luckenwalde Reference material producing in the fields: certified reference materials for organic neat compounds and salts thereof (e. g. pharmaceutically or forensically relevant substances); reference materials for organic neat compounds and salts thereof (e. g. pharmaceutically or forensically relevant substances); reference materials in form of solutions (e. g. pharmaceutically or forensically relevant substances) Abbreviations used: see last page The laboratory is permitted within the specified testing areas marked with *, without being required to inform and obtain prior approval from DAkkS: the modification, development and refinement of test methods. The listed test methods are exemplary. The laboratory maintains a current list of all test methods in a flexible scope of accreditation. This document is a translation. The definitive version is the original German annex to the accreditation certificate. 1/6

2 1 Certified reference materials for organic neat compounds and salts thereof (e. g. pharmaceutically or forensically relevant substances) Product Characteristic Range Pure Organic Substances Identity Relative uncertainty in % Method At least 4 of the following methods: FTIR-ATR, 1H NMR, 13C NMR, MS, melting point (capillary method, DSC), elemental analysis Assay > 95 % m/m 0,3 % Conformity of the test results within the limits of the measurement uncertainty of at least two methods: Titration, 100%-Method HPLC, 100%-Method DSC, carbon titration of the elemental analysis 2 Reference materials for organic neat compounds and salts thereof (e. g. pharmaceutically or forensically relevant substances) Product Characteristic Range Pure Organic Substances Relative uncertainty in % Identity Method Thorough identity checking by several of the following methods or comparison to an international accepted standard: FTIR-ATR, 1H NMR, 13C NMR, MS, melting point (capillary method, DSC), elementary analysis Assay > 90 % m/m < 2 % Assay detection by accredited absolute method or 100%- method (mass balance) with accredited (validated) testing methods Additional assay verification by an independent testing method Period of validity: to Translation 2/6

3 3 Reference materials in form of solutions of organic neat compounds and salts thereof (e. g. pharmaceutically or forensically relevant substances) Product Characteristic Range Method Solutions of pure organic substances Assay 0, g/l Gravimetric production with high precision weighing, on the basis of highly pure starting materials (characterised by quantitative analysis with accredited testing method like e.g. carbon titration of the elemental analysis, examined by 100% - impurities), verified by quantitative analysis (HPLC/GC) against external standard, contamination-free homogenisation and filling The determination of the reference values is based on the following test methods 1 Identity tests of organic compounds with melting point analysis (capillary method)* SOP EXAMPLES Product LGCQUANT Product LGCQUANT Melting Point Identity test of solid, organic pure substances by melting point measurement (capillary method) Identity test of Ethinylestradiol Identity test of Brotizolam 2 Identity tests and assay determinations of organic compounds with elementary analysis * SOP SOP Elemental Analysis Determination of C-, H- and N-content of liquid and solid organic pure substances using elemental analysis for the test on identity Elemental Analysis Content determination of liquid and solid organic pure substances using carbon titration of the elemental analysis Period of validity: to Translation 3/6

4 3 Identity tests and purity determinations of organic compounds with spectroscopy * SOP SOP IR Identity test of solid and liquid organic pure substances by infrared spectroscopy (FTIR-ATR) NMR Identity test of liquid and solid organic pure substances by 1H NMR spectroscopy and by 13C NMR spectroscopy 4 Purity and assay determinations of organic compounds with quantitative nuclear magnetic resonance (qnmr) * SOP SOP Quantitative NMR - Assay determination of solid and liquid organic pure substances Quantitative NMR Determination of residual solvent contents in pure organic compounds 5 Assay determinations of organic compounds with UV-Vis spectroscopy * SOP SOP , Annex 4 UV-Vis Spectrophotometry - Assay determination of organic substances Assay determination of ethanol in aqueous solution with UV/VIS Spectrophotometry via derivatisation with ADH and comparison to a standard 6 Identity tests and purity determinations of organic compounds with mass spectrometry* SOP SOP , Annex 3 MS Identity test of solid and liquid organic pure substances by mass spectrometry (ESI) Determination of the degree of deuteration of organic compounds with HRMS 7 Purity determinations of organic compounds with gravimetry * SOP TGA Determination of residual solvent content of solid organic pure substances by thermal gravimetric analysis Period of validity: to Translation 4/6

5 SOP SOP LOD Determination of residual solvent content of solid organic pure substances by Loss On Drying (LOD) Sulfated Ash Determination of inorganic components in organic pure substances as limit test by Sulphated Ash in a microwave oven 8 Purity and assay determinations of organic compounds in solution with titration * SOP SOP Titration Assay determination of solid and liquid organic pure substances (in solution) by potentiometric titration KFT Determination of water content up to a content of 20% in solid and liquid organic pure substances by Karl-Fischer-Titration - Testing Procedure 9 Purity and assay determinations of organic compounds with gas chromatographie (GC)* SOP SOP EXAMPLES Product LGCAMP Product LGCAMP GCMS-Headspace Residual solvent content in wt% in organic pure substances Purity and assay determinations of organic compounds with GC-MS Purity determination of 7-Aminonitrazepam 1.0 mg/ml in Acetonitrile Purity determination of Chlorpromazine Hydrochloride 1.0 mg/ml in Methanol (as free base) Period of validity: to Translation 5/6

6 10 Purity and assay determinations of organic compounds with HPLC * SOP EXAMPLES Produkt LGCQUANT Produkt LGCQUANT HPLC Purity determination of solid and liquid organic pure substances by HPLC (HPLC with UV-Detector) - Testing Procedure Purity determination of Methyl Parahydroxybenzoate Purity determination of Propyl Parahydroxybenzoate 11 Identity tests and purity determinations of organic compounds with differential scanning calorimetry (DSC) * SOP SOP DSC Purity determination of solid, temperature-stable, organic pure substances with a content >98.5% by DSC Melting Point Identity test of solid organic pure substances by melting point measurement (DSC) Abbreviations used: DSC ESI FTIR-ATR GCMS HPLC NMR SOP Differential Scanning Calorimetry Electrospray-Ionisation Fourier Transform Infrared Spectroscopy Attenuated Total Reflectance Gas Chromatography-Mass Spectrometry High-Performance Liquid Chromatography Nuclear magnetic resonance Standard operation procedure at LGC GmbH Period of validity: to Translation 6/6

Period of validity: to date of issue:

Period of validity: to date of issue: Deutsche Akkreditierungsstelle GmbH Annex to the Accreditation Certificate D-RM-14176-01-00 according to the relevant clauses of ISO Guide 34: and DIN EN ISO/IEC 17025:2005 Period of validity: 11.01.2016