半岛bd体育手机客户端 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 BY?Spec. 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, CO?-free water)5.5 - 7.0Chloride (Cl)≤ 200 ppmSulfate (SO?)≤ 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

基本信息

分子量	131.17
MDL编号	MFCD00064222
EC索引号	200-798-2

半岛bd体育手机客户端 性质

agency	Ph. Eur. USP
质量水平	500
半岛bd体育手机客户端 线	EMPROVE?ESSENTIAL
pH值(酸碱度)	5.5-6.5 (20 ℃, 40 g/L in H2O)
mp	279-280 ℃ (decomposition)
溶解性	40 g/L
堆积密度	470 kg/m3
储存温度	2-30℃
InChI	1S/C6H13NO2/c1-3-4(2)5(7)6(8)9/h4-5H,3,7H2,1-2H3,(H,8,9)/t4-,5-/m0/s1
InChI key	AGPKZVBTJJNPAG-WHFBIAKZSA-N

安全信息

储存分类代码	13 - Non Combustible Solids
WGK	WGK 1
闪点(F)	Not applicable
闪点(C)	Not applicable