产品说明

一般描述

EMPROVE^® ESSENTIAL Ph Eur,USP

分析说明

Assay (perchloric acid titration, calculated on dried substance)98.5 - 101.0 %Identity (IR-spectrum)passes testAppearancewhite to almost white, crystalline powder or flakesAppearance of solution (50 g/l, hydrochloric acid 1 mol/l)clear and not more intense in color than reference solution BY₆Spec. rotation (α 20/D, 40 g/l, Hydrochloric acid 250 g/l, calc. on dried substance)+40.0 to +43.0Spec. rotation (α 25/D, 40 g/l, hydrochloric acid 6 mol/l, calc. on dried substance)+38.9 to +41.8pH (10 g/l, CO₂-free water)5.5 - 7.0Chloride (Cl)≤ 200 ppmSulfate (SO₄)≤ 300 ppmHeavy metals (as Pb)≤ 10 ppmFe (Iron)≤ 10 ppmFe (Iron) (ICP)≤ 10 ppmMn (Manganese)≤ 25 ppmRelated substances (TLC)≤ 0.5 %Related compounds (HPLC) (Leucine)≤ 0.5 %Related compounds (HPLC) (any unspecified impurity)≤ 0.2 %Related compounds (HPLC) (total unspecified impurities)≤ 1.0 %Ninhydrin-positive substances (LC)(impurity A (570 nm))≤ 0.3 %Ninhydrin-positive substances (LC)(impurity C (570 nm))≤ 0.3 %Ninhydrin-positive substances (LC)(any ninhydrin-positive impurity)≤ 0.2 %Ninhydrin-positive substances (LC) (ammonium (570 nm))≤ 0.02 %Ninhydrin-positive substances (LC)(total impurities)≤ 1.0 %Methanol (HS-GC)≤ 3000 ppmOther residual solvents (ICH Q3C)excluded by manufacturing processSulfated ash (600 °C)≤ 0.1 %Loss on drying (105 °C; 3 h)≤ 0.3 %Elemental impurity specifications have been set considering ICH Q3D (Guideline for Elemental Impurities). Class 1-3 elements are not likely to be present above the ICH Q3D option 1 limit, unless specified and indicated (*).Corresponds to Ph. Eur., USP.

法律信息

Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany

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