CertiPUR. A class of its own. Merck s ICP Laboratory now with ISO accreditation

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1 CertiPUR A class of its own. Merck s ICP Laboratory now with ISO accreditation

2 CertiPUR We are setting new standards What are your benefits of ISO accreditation? An interview with Dr. Dietmar Oeter, Senior Manager Quality Control Life Science & Analytics at Merck Darmstadt Dr. Oeter, which laboratory and which analytical method was accredited? Accreditation as a calibration laboratory covers the quality control of single element standards using the precision analysis method ICP-OES within our reference material laboratory. Why did Merck strive for accreditation of these reference materials? Reference materials for calibrating analytical instruments in elemental analysis are the fundamental basis in all trace analysis laboratories worldwide. The accreditation attests the technical correctness and validity of our quality control procedures for these reference materials. The accreditation also further corroborates the confidence in Merck as a manufacturer of reference materials. Moreover, the accreditation enables us to take on external orders as a calibration laboratory. Dr. Dietmar Oeter, Senior Manager Quality Control Life Science & Analytics at Merck Darmstadt, on the occasion of CertiPUR ISO accreditation. The accreditation as a calibration laboratory conforms to DIN EN ISO What does this mean? The main element of DIN EN ISO is the required analysis of the uncertainty of the measurement carried out. In order to fully determine the uncertainty, an uncertainty budget is set up, which considers all potential influencing variables and their effects on the uncertainty of the measurement. The resulting uncertainty must then be stated on the certificate of analysis with the valid measuring result. Does this satisfy your customers demands? DIN EN ISO accreditation covers requirements in Europe and Asia. In practice, we also gear our procedures to the requirements of ISO Guide 34, approving not only the quality control system, but in addition the stability and the homogeneity of the materials produced. ISO Guide 34 meets with a high level of acceptance among users in the United States and the Asia-Pacific region. Which member of the German Accreditation Council (DAR) carried out the inspection? Merck applied to the German Calibration Service (DKD) for accreditation as a calibration laboratory. Accreditation from the DKD gives the laboratory international recognition by the Multilateral Agreement of the EA (European Cooperation for Accreditation). The results of the relevant laboratories are thus mutually recognized on an international level by the Mutual Recognition Arrangement of the ILAC (International Laboratory Accreditation Cooperation). Furthermore, Merck already has a DKD-accredited laboratory for ph and conductivity measurement. We are thus able to meet the requirements specified for the quality management system in the second laboratory based on this experience. Merck is a pioneer in elemental analysis. Can you give us an example of your current activities? Merck is a partner in a joint project with German metrological institutions to provide traceability of standards for elemental analysis to the SI unit (kg). As an industrial company we make a significant contribution to the development of a German traceability as a basic parameter for our range of secondary reference materials.

3 Benefits for you: Traceable certified reference materials DIN EN ISO compliant element standard solutions Valid measuring results generated by an accredited calibration laboratory Measuring uncertainty included on the certificate of analysis as a GUM uncertainty budget CertiPUR Not all reference materials are the same.

4 CertiPUR ICP Single element standards ICP Standards are directly traceable to standard reference material from NIST. A certificate of analysis is enclosed in each package. It includes information of the calibration lab, exact data on content and uncertainty, trace element impurities, composition, traceability, date of release and minimum shelf life. A B C D E G H I L M N O Designation Element Composition ICP 1,000 mg/l ICP 10,000 mg/l Order No. [100 ml] Order No. [100 ml] Aluminium Al Al(NO 3 ) 3 in HNO 3 2 3% Antimony Sb Sb 2 O 3 in HCl 7% Arsen As H 3 AsO 4 in HNO 3 2 3% Barium Ba Ba(NO 3 ) 2 in HNO 3 2 3% Beryllium Be Be 4 O(C 2 H 3 O 2 ) 6 in HNO 3 2 3% Bismuth Bi Bi(NO 3 ) 3 in HNO 3 2 3% Boron B H 3 BO 3 in water Cadmium Cd Cd(NO 3 ) 2 in HNO 3 2 3% Calcium Ca Ca(NO 3 ) 2 in HNO 3 2 3% Cerium Ce Ce(NO 3 ) 3 in HNO 3 2 3% Cesium Cs CsNO 3 in HNO 3 2 3% Chromium Cr Cr(NO 3 ) 3 in HNO 3 2 3% Cobalt Co Co(NO 3 ) 2 in HNO 3 2 3% Copper Cu Cu(NO 3 ) 2 in HNO 3 2 3% Dysprosium Dy Dy 2 O 3 in HNO 3 2 3% Erbium Er Er 2 O 3 in HNO 3 2 3% Europium Eu Eu 2 O 3 in HNO 3 2 3% Gadolinium Gd Gd 2 O 3 in HNO 3 2 3% Gallium Ga Ga(NO 3 ) 3 in HNO 3 2 3% Germanium Ge (NH4) 2 GeF 6 in water Gold Au H(AuCl 4 ) in HCl 7% Hafnium Hf HfOCl 2 in HCl 7% Holmium Ho Ho 2 O 3 in HNO 3 2 3% Indium In In(NO 3 ) 3 in HNO 3 2 3% Iridium Ir IrCl 3 in HCl 7% Iron Fe Fe(NO 3 ) 3 in HNO Lanthanum La La(NO 3 ) 3 in HNO 3 2 3% Lead Pb Pb(NO 3 ) 2 in HNO 3 2 3% Lithium Li LiNO 3 in HNO 3 2 3% Luthetium Lu Lu 2 O 3 in HNO 3 2 3% Magnesium Mg Mg(NO 3 ) 2 in HNO 3 2 3% Manganese Mn Mn(NO 3 ) 2 in HNO 3 2 3% Mercury Hg Hg(NO 3 ) 2 in HNO 3 10% Molybdenum Mo (NH 4 ) 6 Mo 7 O 24 in water Neodymium Nd Nd 2 O 3 in HNO 3 2 3% Nickel Ni Ni(NO 3 ) 2 in HNO 3 2 3% Niobium Nb NH 4 NbF 6 in water Osmium Os (NH 4 ) 2 OsCl 6 in HCl 7%

5 CertiPUR ICP Single element standards P R S T V Y Z Designation Element Composition ICP 1,000 mg/l ICP 10,000 mg/l Order No. [100 ml] Order No. [100 ml] Palladium Pd Pd(NO 3 ) 2 in HNO 3 2 3% Phosphorous P H 3 PO 4 in water Platinum Pt H 2 PtCl 6 in HCl 7% Potassium K KNO 3 in HNO 3 2 3% Praseodymium Pr Pr 2 O 3 in HNO 3 2 3% Rhenium Re NH 4 ReO 4 in water Rhodium Rh Rh(NO 3 ) 3 in HNO 3 2 3% Rubidium Rb RbNO 3 in HNO 3 2 3% Ruthenium Ru RuCl 3 in HCl 7% Samarium Sm Sm 2 O 3 in HNO 3 2 3% Scandium Sc Sc 2 O 3 in HNO 3 7% Selenium Se SeO 2 in HNO 3 2 3% Silicon Si SiO 2 in NaOH Silver Ag AgNO 3 in HNO 3 2 3% Sodium Na NaNO 3 in HNO 3 2 3% Strontium Sr Sr(NO 3 ) 2 in HNO 3 2 3% Sulfur S H 2 SO 4 in water Tantalum Ta (NH 4 ) 2 TaF 7 in water Tellurium Te H 6 TeO 6 in HNO 3 2 3% Terbium Tb Tb(NO 3 ) 3 in HNO 3 2 3% Thallium Tl TlNO 3 in HNO 3 2 3% Thulium Tm Tm(NO 3 ) 3 in HNO 3 2 3% Tin Sn SnCl 4 in HCl 7% Titanium Ti (NH 4 ) 2 TiF 6 in water (trace HF) Tungsten W (NH 4 ) 2 WO 4 in water Vanadium V NH 4 VO 3 in HNO Ytterbium Yb Yb 2 O 3 in HNO 3 2 3% Yttrium Y Y(NO 3 ) 3 in HNO 3 2 3% Zinc Zn Zn(NO 3 ) 2 in HNO 3 2 3% Zirconium Zr ZrOCl 2 in HCl Designation Element Composition ICP 10 mg/l Order No. [100 ml] Rhodium Rh 10 mg/l Rh(NO 3 ) 3 in HNO 3 2 3% (internal standard for ICP) Mercury Hg 10 mg/l Hg(NO 3 ) 2 in HNO 3 2 3% CertiPUR by Merck now with ISO accreditation to give you reliable measuring results.

6 W /04 Merck KGaA Darmstadt, Germany Fax +49(0)6151/ We provide information and advice to our customers to the best of our knowledge and ability, but without obligation or liability. Existing laws and regulations are to be observed in all cases by our customers. This also applies in respect to any rights of third parties. Our information and advice do not relieve our customers of their own responsibility for checking the suitability of our products for the envisaged purpose. CertiPUR is a registered trademark of Merck KGaA, Darmstadt, Germany.