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100490 有机混合物

概述

Replacement Information

Products

产品目录编号包装 数量 / 包装
1.00490.1000 塑胶瓶 1 kg
描述
产品目录编号100490
参考
产品信息
HS代码3824 99 89
Quality LevelMQ500
应用
生物信息
理化信息
尺寸
材料信息
毒性学信息
GHS安全信息
储存类别10 - 13 其它液体及固体
WGKWGK 1 轻度的水危害
一次性3
反应性相对较低的有机物必须被收集在第A类, 如果被卤化则在第B类, 如果为固体残留物则归在第C类.
安全信息
产品使用声明
储存和货运信息
储存于 +2°C 到 +30°C储存.
包装信息
运输信息
补充信息
规格
Identitypasses test
Appearance (description)fine powder
Appearance (color)white
Assay (mannitol)90.0 - 95.0 %
Assay (Croscarmellose-Sodium)3.0 - 7.0 %
Ni (Nickel)*≤ 0.0001 %
Heavy metals (as Pb)≤ 0.0005 %
Ethanol (HS-GC)≤ 5000 ppm
Other residual solvents (ICH Q3C)excluded by manufacturing process
Water (according to Karl Fischer)≤ 2 %
Microbiological purity (Total aerobic microbial count (TAMC))≤ 2000 CFU/g
Microbiological purity (Total yeast and mould count (TYMC))≤ 200 CFU/g
Bile tolerant Gram negative Bacteria (absent in 1 g)conforms
Escherichia coli (absent in 1 g)conforms
Pseudomonas aeruginosa (absent in 1 g)conforms
Staphylococcus aureus (absent in 1 g)conforms
Candida albicans (absent in 1 g)conforms
Salmonella ssp (absent in 10 g)conforms
Particle size (laser diffraction) (d10)30 - 90 µm
Particle size (laser diffraction) (d50)80 - 220 µm
Particle size (laser diffraction) (d90)170 - 520 µm
The Mannit and Croscarmellose-Na used for the production correspond to Ph Eur, USP/NF and JP.
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 (*).
Global Trade Item Number
产品目录编号 GTIN
1.00490.1000 04027269144531

Documentation

Material Qualification Dossier

标题版本
9.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

有机混合物 MSDS

职位

物料安全数据表 (MSDS) 

有机混合物 分析证书

产品货号 包装规格批号
1.00490.1000 塑胶瓶PDF文档规格

证书

标题