Merck Darmstadt (JA-536)

Audit # JA-536
Region Europe
Standards API/Excipients/Basic Chemicals/Raw Materials
Company Merck Darmstadt
Location Darmstadt, Germany
Date 28-30 May 2015
Materials EMPROVE® APIs: Potassium Iodide 105040 ; Mannitol 105303 ; Sodium Fluoride 106441 ; Urea cryst. 108432 ; Zinc Chloride 108815 ; di-Potassium Hydrogen Phosphate 109828 ; Calcium Chloride Dihydrate 102465 ; Magnesium Chloride 102367 ; EMPROVE® Excipients: ;Acetic Acid 100056 ; Adipic Acid 100090 ; Citric Acid Anhydride 100241 ; Citric Acid Monohydrate 100242 ; L-Glutamine 100286 ; Hydrochloric Acid 100314 ; (S)-Lactic Acid 100366 ; Phosphoric Acid 100563 ; Succinic Acid 100681 ; Tartaric Acid 100803 ; Titanium Oxide 100805 ; Benzyl Alcohol 100981 ; Ethanol absolute 100986 ; Benzyl Alcohol 100987 ; Isopropyl Alcohol 100995 ; L-Arginine 101587 ; Calcium Carbonate 102069 ; Chloroform 102431 ; Copper Sulphate anhydrous 102792 ; Iron-III-Chloride Hexahydrate 103814 ; Glycerol about 87% 104091 ; Potassium Dihyrdrogen Phosphate cryst. 104871 ; Potassium Chloride 104935 ; Potassium Sulphate 105150 ; Magnesium Chloride 105832 ; Magnesium Oxide heavy 105867 ; Manganese Sulphate Monohydrate 105999 ; Sodium Benzoate 106290 ; Sodium Bicarbonate 106323 ;Sodium Dihydrogen Phosphate Dihydrate 106345 ; Sodium Hydrogen Phosphate monohydrate 106349 ; Sodium Carbonate monohydrate 106386 ; Sodium Chloride 106400 ; tri-Sodium Citrate Dihydrate, cryst. 106432 ; tri-Sodium Citrate Dihydrate 106447 ; Sodium Hydroxide Pellets 106482 ; Sodium Phosphate Dodecahydrate 106573 ; di-Sodium Hydrogen Phosphate Dihydrate 106576 ; di-Sodium Hydrogen Phosphate anhydrous 106585 ; Stannous Chloride Dihydrate 107813 ; Talc, purified 108070 ; D-Glucose Monohydrate 108346 ; Di-Sodium Edetate (manuf. at Merck Spain) 108421 ; Zinc Sulphate Heptahydrate 108881 ; Zinc Sulphate Monohydrate 108882 ; D(-) Mannitol 112635 ; Sodium Chloride low in Endotoxins 116224 ; Poly 10% solution (PDADMAC) 137069 ; Glycine cryst. 500190 ; Glycine cryst. 100590 ; Polysorbate, TWEEN 20 ;Calcium Chloride Dihydrate 817072 ;142002 ;Material without pharmaceutical quality marker (continued): Sodium Phosphate Monobasic 104873 ; Sodium Carbonate 106392 ; Sodium Chloride 106404 ; Bibasic Sodium Phosphate Dihydrate 106580 ; Disodium Hydrogen Phosphate anhydrous 106586 ; Nickel Sulfate dried 106727 ; Meat Peptone 107224 ; D-Glucose for microbiology 108342 ; Sucrose, beet derived low Endotoxin 108992 ; Isopropylic Alcohol 109634 ; Sodium Hydroxide 1N 109956 ; Hydrochloric Acid 1N 109970 ; Nicotinamide Adenine Dinucleotide 124542 ; Benzalkonium Chlroide 817032 ; Polysorbate Tween 80 817061 ;

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