Working with ACS specified products. Merck validates the»gr for Analysis«reagent range according to actual ACS standards

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1 Working with ACS specified products Merck validates the»gr for Analysis«reagent range according to actual ACS standards

Monitoring the quality of our reagents, we follow the specifications of the monographs published in Reagent Chemicals from the American Chemical Society (ACS). As our customers know, Merck has a Dr.

2 Monitoring the quality of our reagents, we follow the specifications of the monographs published in Reagent Chemicals from the American Chemical Society (ACS). As our customers know, Merck has a Dr. Dietmar Oeter, Head of Quality Control at Merck Darmstadt:»Validating the range of»gr for Analysis«products were very extensive. But now we are sure to meet our customers needs.«special regard concerning quality and reliability of its products. We take an in-depth approach to the ACS specifications, comparing them with our own in-house requirements. Consequently, we verify a range of the most representative reagents. The result is no surprise: In most cases, our state-of-the-art For more information about the 9th edition of ACS source book please refer to» analytical methods verify that»gr for Analysis«grade chemicals meet or exceed the ACS requirements in the last edition of»reagent Chemicals«. 2

Most of our reagent chemicals meet the ACS specifications almost all out perform ACS Sometimes, in our opinion, the ACS specifications are limited in scope.

3 Most of our reagent chemicals meet the ACS specifications almost all out perform ACS Sometimes, in our opinion, the ACS specifications are limited in scope. Thus, we analyse additional parameters than required by ACS. In addition to these specifications Merck follows their own quality standards resulting from more than 300 years of experience as a global producer of lab chemicals. Other parameters not requested by ACS are tested according to the Specifications of the European based»international Organization for Standardization«(ISO). Our Validation plan for ACS reagents has been carried out according to the very strict validation instructions for pharmaceutical starting materials (e.g. according to USP and ICH Q2A Guideline for Industry, Text on Validation of Analytical Procedures (1995)). Validation plan Assay Anions* with Total Nitrogen ion chromatography (N) Comparison of methods yes yes yes Trueness yes no yes Repeatability yes yes yes Specificity yes yes yes Linearity yes yes yes Limit of determination no yes yes Limit of detection no yes yes Ruggedness yes no yes Example Sodium chloride: * Anions: Bromide (Br), Chlorate and Nitrate (as NO 3 ), Iodide (I), Phosphate (PO 4 ), Sulfate (SO 4 ). Dr. Matthias Ohm and Dr. Kerstin Reider, Quality control managers at Merck, Germany:»In our labs we are working with absolutely stateof-the-art technology.«

«we know what the ACS Reagent Committee requires Last but not least, because one of our quality control managers, Chuck Wilson, has been a member of the ACS Committee on Analytical Reagents since

4 Chuck Wilson, Quality Control Manager at EMD Chemicals Inc., USA:»Analysts may apply alternative methods of analysis but, these methods must be validated to assure that they produce results of at least equal reliability.«we know what the ACS Reagent Committee requires Last but not least, because one of our quality control managers, Chuck Wilson, has been a member of the ACS Committee on Analytical Reagents since Chuck has been with our subsidiary in the US since 1972 and Merck is proud that he is part of the team that»wrote the book«on analytical reagents. Our analytical specialists have valid reasons for using alternative methods There are some scientifically sound reasons to use an alternative method over an ACS monograph. Some analytical methods result in precisely quantified values not only a comparison to limiting values. In order to get more meaningful and precise results, Merck applies our own in-house methods with our quality control procedures. These leading-edge technologies are, for example, anion chromatography, photometry for ammonium determination vs. wet chemical comparison to a reference solution. This is our enduring commitment to the state-of-the-art standards of service and quality. Birgit Sauerbrey, Laboratory assistant at Merck, Germany:»Merck s products are tested to meet our customer s requirements. We perform analyses on every batch so the customer receives effective analysed data every time.«

5 Example: Validating sodium chloride [Item ] Parameter Specification ACS Specification Merck Method Merck vs. ACS Analytical method ACS Analytical method Merck Assay 99.0 % 99.5 % validated argentometric titration argentometric titration (visual indication) (potentiometer indication) ph-value (5 %, water) follows ACS ph potentiometry ph potentiometry Water insoluble substances max % % follows ACS gravimetric gravimetric Bromide (Br) max % % validated anion chromatography Chlorate and Nitrate (as NO 3 ) max % % validated and photometry anion chromatography Hexacyanoferrate [Fe(CN) 6 ] [no specification] % follows ISO Iodide (I) max % % validated anion chromatography Phosphate (PO 4 ) max % % validated colorimetry anion chromatography (direct molybdenum blue) Sulfate (SO 4 ) max % % validated anion chromatography Total Nitrogen (N) max % % validated Kjeldahl Kjeldahl (comparison of limiting values) (effective) Heavy metals (as Pb) max % % follows ACS As (Arsenic) [no specification] % In-house Ba (Barium) passes test passes test follows ACS Ba (Barium) [no specification] % follows ISO Ca (Calcium) max % % follows ACS flame AAS flame AAS Cu (Copper) [no specification] % In-house pulse polarography Fe (Iron) max % % follows ACS K (Potassium) max % % follows ACS flame AAS flame AAS Mg (Magnesium) max % % follows ACS flame AAS flame AAS Ca, Mg und Me 2 O 3 -precipitate [no specification] % In-house gravimetric method Sodium Chloride as an example shows, that a Merck product combines perfectly ACS, ISO and other important parameters. In summary you can fully rely on a Merck»GR for Analysis«graded product. 5

The»Merck GR for Analysis ACS range«: Our synonym for products of guaranteed purity Following Good Laboratory Practice (GLP) or other quality systems is now easier than before.

6 The»Merck GR for Analysis ACS range«: Our synonym for products of guaranteed purity Following Good Laboratory Practice (GLP) or other quality systems is now easier than before. Merck s»gr for Analysis«reagents meet ACS quality specifications ensuring the reliability, availability, convenience, packaging versatility and quality our customers need. Dr. Konrad Beckenkamp, Head of Quality Control at Merck, Germany:»Validated»GR for Analysis«products meet all requirements of demanding and critical customers.«6

7 ACS Products Designation Package size Cat. No.* Acetic acid (glacial) 100 % 2,5 l Acetic anhydride 2,5 l Acetone 2,5 l Acetonitrile 2,5 l Aluminium potassium sulfate dodecahydrate 1 kg Ammonia Solution 28 30% 1 l Ammonium acetate 1 kg Ammonium amidosulfonate (for detection of sulfonamide in blood) 100 g Ammonium bromide 1 kg Ammonium carbonate 250 g Ammonium cerium(iv) nitrate 1 kg Ammonium chloride 1 kg Ammonium dihydrogen phosphate 500 g Ammonium fluoride 250 g Ammonium heptamolybdate tetrahydrate 1 kg di-ammonium hydrogen citrate 500 g di-ammonium hydrogen phosphate 500 g Ammonium iodide 250 g Ammonium iron(iii) sulfate dodecahydrate 1 kg Ammonium nitrate 1 kg di-ammonium oxalate monohydrate 250 g Ammonium peroxodisulfate 1 kg Ammonium sulfate 1 kg Ammonium thiocyanate 500 g Anthrone 10 g Aurin tricarboxylic acid ammonium salt (reagent for aluminium) 25 g Barium acetate 500 g Barium carbonate 1 kg Barium chloride dihydrate 1 kg Barium hydroxide octahydrate 500 g Barium nitrate 500 g Benzene 2,5 l Benzoic acid 100 g Boric acid 1 l Bromine 250 g Bromocresol green (indicator) 25 g Bromophenol blue (indicator ph ) 25 g Bromophenol blue sodium salt (water-soluble indicator) 5 g Bromothymol blue (indicator) 25 g Bromthymol blue sodium salt (water-soluble indicator) 10 g Butanol 2,5 l tert-butanol 5 l Cadmium sulfate hydrate 100 g Calcium chloride dihydrate 1 kg Calcium hydroxide 1 kg * for further packsizes see the Merck Reagents Catalogue, ChemDAT the Merck Chemical Database on CD-ROM or ChemDAT -online on Internet under 7

8 ACS Products Designation Package size Cat. No.* Calcium nitrate tetrahydrate 500 g Carbon disulfide 1 l Chloramin T 250 g Chloroform 2,5 l Chromium(III) potassium sulfate dodecahydrate 250 g Citric acid monohydrate 1 kg Cobalt(II) chloride hexahydrate 250 g Cobalt(II) nitrate hexahydrate 250 g Copper oxide (wire about 0.65 x 6 mm for elementary analysis, surface: CuO, core: Cu 2 O) 250 g Copper oxide (wire fine about 0.65 x 3 mm for elementary analysis) 250 g Copper(I) chloride 250 g Copper(II) chloride dihydrate 1 kg Copper(II) sulfate pentahydrate 1 kg Cupferron 100 g Cyclohexane 2,5 l ,2-Dichlorethane 500 ml ,7 -Dichlorfluorescein 5 g Dichloromethane 2,5 l Diethyl ether 1 l Diisopropyl ether 2,5 l (Dimethylamino)benzaldehyde 100 g N,N-Dimethylformamide 2,5 l Dimethylglyoxime (reagent for nickel) 100 g Dimethyl sulfoxide 1 l ,4-Dioxan 2,5 l Diphenylamine 100 g ,5-Diphenylcarbazide 25 g ,5-Diphenylcarbazone 5 g Erichrom black T 25 g Ethanol 2,5 l Ethyl acetate 2,5 l Ethyl methyl ketone 2,5 l Ethylene glycol monomethyl ether 2,5 l Formaldehyde solution min. 37 % (stabilized with about 10 % methanol) 1 l Formamide 2,5 l Formic acid % 1 l Formic acid % 2,5 l Fufural 100 g Glycerol 2,5 l n-hexane 2,5 l n-hexane 2,5 l Hydrazinium sulfate 100 g Hydrochloric acid fuming 37% 2,5 l Hydrofluoric acid 48% 500 ml Hydroxylammonium chloride 250 g Hydroxylammonium chloride ( % Hg) 250 g

9 ACS Products Designation Package size Cat. No.* 8-Hydroxyquinoline 250 g Imidazole (buffer substance) 250 g Iodic acid 100 g Iodine (resublimed) 500 g Iron(II) sulfate heptahydrate 1 kg Iron(III) chloride hexahydrate 1 kg Iron(III) nitrate nonahydrate 1 kg Isoamyl alcohol 2,5 l Isobutanol 1 l Isobutyl methyl ketone (for extraction analysis) 2,5 l Isooctane 2,5 l Lead(II) acetate trihydrate 1 kg Lead(II) carbonate 250 g Lead(II) hydroxide acetate (anhydrous, for the analysis of sugar acc. to Horne) 1 kg Lead(II) nitrate 1 kg Lithium carbonate 250 g Lithium chloride 250 g Lithium sulfate monohydrate 250 g Magnesium acetate tetrahydrate 1 kg Magnesium chloride hexahydrate 1 kg Magnesium nitrate hexahydrate 500 g Magnesium oxide 500 g Magnesium sulfate heptahydrate 1 kg Manganese(II) chloride tetrahydrate 1 kg Manganese(II) sulfate monohydrate (spray-dried) 250 g Mercury(II) acetate 250 g Mercury(II) bromide 50 g Mercury(II) chloride 250 g Mercury(II) iodide (red) 250 g Mercury(II) nitrate monohydrate 50 g Mercury(II) sulfate 250 g Methanol 2,5 l Methyl orange (C.I.13025, indicator) 25 g Methyl red (C.I , indicator) 25 g Molybdatophosphoric acid hydrate 100 g Murexide (ammonium purpurate, metal indicator) 25 g Ninhydrin 100 g Nitric acid fuming 100 % 1 l Nitric acid 69% 2.5 l Oxalic acid dihydrate 1 kg Perchloric acid 60 % 2,5 l Perchloric acid % 2,5 l Perchloric acid 70 % (max. 0,000005% Hg) 1 l Petroleum benzine (boiling range C) 2,5 l Phenol 1 kg Phenol red (indicator) 25 g Phenol red sodium salt (indicator) 5 g

10 ACS Products Designation Package size Cat. No.* Phenolphthalein (indicator) 25 g Ortho-Phosphoric acid 85% 1 l di-phosphorus pentoxide 500 g Potassium bromate 250 g Potassium bromide 500 g Potassium carbonate 1 kg Potassium chloride 500 g Potassium chromate 1 kg Potassium cyanide 1 kg Potassium dichromate 500 g Potassium dichromate (max % Hg) 500 g Potassium dihydrogen phosphate 1 kg Potassium disulfate (Potassium pyrosulfate) 1 kg Potassium hexacyanoferrate(ii) trihydrate 500 g Potassium hexacyanoferrate(iii) 1 kg Potassium hydroxide pellets (max % Na) 1 kg Potassium hydroxide pellets (max. 0.05% Na) 1 kg Potassium iodate 500 g di-potassium oxalate monohydrate 1 kg Potassium perchlorate 1 kg Potassium permanganate 1 kg Potassium permanganate (max % Hg) 1 kg Potassium peroxodisulfate 250 g Potassium sodium tartrate tetrahydrate 1 kg Potassium sulfate 1 kg Potassium thiocyanate 1 kg Propanol 1 l Propanol 2,5 l Pyridine 2,5 l Pyrogallol (1,2,3-trihydroxybenzene) 50 g Silica gel with moisture indicator (blue gel, 0,2-1 mm, desiccant) 1 kg Silica gel with moisture indicator (blue gel, 1 3 mm, desiccant) 1 kg Silver diethyldithiocarbamate (reagent for arsenic and antimony) 5 g Silver sulfate 100 g Sodium acetate (anhydrous) 1 kg Sodium acetate trihydrate (indifferent to potassium permanganate) 1 kg Sodium carbonate (anhydrous) 1 kg Sodium chloride 1 kg tri-sodium citrate dihydrate 1 kg Sodium dichromate dihydrate 1 kg Sodium diethyldithiocarbamate trihydrate (reagent for copper) 100 g Sodium dihydrogen phosphate monohydrate 1 kg tetra-sodium diphosphate decahydrate 500 g Sodium disulfite (sodium metabisulfite) 1 kg

11 ACS Products Designation Package size Cat. No.* Sodium fluoride 1 kg Sodium formate 500 g Sodium hexanitrocobaltate(iii) (sodium cobalt(iii) nitrite) 100 g Sodium hydrogen carbonate 1 kg di-sodium hydrogen phosphate (anhydrous) 2,5 kg di-sodium hydrogen phosphate heptahydrate 1 kg Sodium hydroxide (pellets) (max. 0.02% K) 1 kg Sodium hydroxide (pellets) (max % K) 1 kg Sodium metaperiodate 250 g Sodium nitrate 1 kg Sodium nitrite 500 g Sodium nitroprusside dihydrate (disodium pentacyanonitrosyl ferrate(ii) dihydrate) 1 kg Sodium peroxide 500 g tri-sodium phosphate dodecahydrate 1 kg Sodium sulfate (anhydrous) 1 kg Sodium sulfate (anhydrous, coarse granules mm) 1 kg Sodium sulfate decahydrate 1 kg Sodium sulfite (anhydrous) 1 kg di-sodium tetraborate decahydrate 1 kg Sodium tetraphenyl borate 1 kg Sodium thiosulfate pentahydrate 1 kg Strontium chloride hexahydrate 1 kg Sulfanilic acid 100 g Sulfuric acid % 2,5 l L(+)-Tartaric acid 1 kg Tetrahydrofuran 2,5 l Thiourea 250 g Thymol blue (indicator) 25 g Thymol blue sodium salt (water-soluble indicator) 5 g Thymolphthalein (indicator) 25 g Tin(II) chloride dihydrate 1 kg Titriplex II (ethylenedinitrilotetraacetic acid) 1 kg Titriplex III (ethylenedinitrilotetraacetic acid, disodium salt dihydrate) 1 kg Toluene 2,5 l Trichloroacetic acid 1 kg Trichloroethylene 2,5 l ,1,2-Trichlorotrifluoroethane 2,5 l Tris(hydroxymethyl)aminomethane (buffer substance) 500 g Urea 1 kg Xylene 2,5 l Xylenol orange tetrasodium salt (metal (pm) indicator) 5 g Zinc chloride 1 kg Zinc oxide 1 kg Zinc sulfate heptahydrate 1 kg

12 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. W Release date: October 2005 Merck KGaA Darmstadt, Germany Fax 0049 (0)

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