半岛bd体育手机客户端 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 Y?Spec. 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 (SO?)≤ 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

基本信息

分子量	181.19
MDL编号	MFCD00002606
EC索引号	200-460-4

半岛bd体育手机客户端 性质

质量水平	500
agency	JP Ph. Eur. USP
半岛bd体育手机客户端 线	EMPROVE?EXPERT
效能	>5110 mg/kg LD50, oral (Rat)
pH值(酸碱度)	6.5 (0.1 g/L in H2O)
mp	297-298 ℃ (decomposition)
溶解性	0.38 g/L
密度	1.46 g/cm3at 20 ℃
堆积密度	300 kg/m3
储存温度	2-30℃
InChI	1S/C9H11NO3/c10-8(9(12)13)5-6-1-3-7(11)4-2-6/h1-4,8,11H,5,10H2,(H,12,13)
InChI key	OUYCCCASQSFEME-UHFFFAOYSA-N

安全信息

储存分类代码	13 - Non Combustible Solids
WGK	WGK 1