产品说明

一般描述

EMPROVE^® EXPERT Ph Eur,JP,USP

分析说明

Assay (perchloric acid titration, calculated on dried substance)99.0 - 101.0 %Identity (IR-spectrum)passes testIdentity (specific rotation)passes testAppearancewhite to almost white, crystalline powder or colorless crystalsAppearance of solution(25 g/l, Hydrochloric acid 2 mol/l)clear and not more intense in color than reference solution Y₇Spec. rotation (α 20/D, 50 g/l, hydrochloric acid 1 mol/l, calc. on dried substance)-11.0 to -12.3Spec. rotation (α 25/D, 50 g/l, hydrochloric acid 1 mol/l, calc. on dried substance)-9.8 to -11.2Chloride (Cl)≤ 200 ppmSulfate (SO₄)≤ 300 ppmFe (Iron)≤ 10 ppmRelated Compounds, total (TLC)≤ 0.5 %Ninhydrin-positive substances (LC)(impurity A (570 nm))≤ 0.5 %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)≤ 0.6 %Residual solvents (ICH (Q3C))excluded by manufacturing processSulfated ash (600 °C)≤ 0.1 %Loss on drying (105 °C; 3 h)≤ 0.3 %Bacterial endotoxins≤ 20 I.U./gMicrobiological test (total aerobic microbial count (TAMC))≤ 100 CFU/gMicrobiological test (total yeast and mould count (TYMC))≤ 100 CFU/gElemental 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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