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500859 维生素 E 干粉(100 g 物质中含 50 g 生育酚乙酸酯)

概述

Replacement Information

重要规格表

级别值
Ph Eur,BP,USP

Products

产品目录编号包装 数量 / 包装
5.00859.2500 塑胶瓶 2.5 kg
描述
产品目录编号500859
参考
产品信息
级别Ph Eur,BP,USP
HS代码2106 90 90
Quality LevelMQ500
应用
生物信息
理化信息
pH值7 (50 g/l, H₂O, 20 °C) (残渣)
容积密度360 kg/m3
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 +25°C储存.
包装信息
运输信息
补充信息
规格
all-rac-α-Tocopheryl acetate content (GC, Ph Eur)50.0 - 57.5 %
all-rac-α-Tocopheryl acetate content (GC, USP)49.0 - 57.5 %
Identity (TLC)conforms
Identity (GC)passes test
Identity (wet chemistry)passes test
Identity (optical rotation)passes test
Optical rotation α 25/D (all-rac-α-Tocopheryl acetate)-0.01 - 0.01 °
Heptane (HS-GC)≤ 5000 ppm
Methanol (HS-GC)≤ 3000 ppm
Other residual solvents (ICH Q3C)excluded by production process
Loss on drying (130 °C, vacuum, 4 h)≤ 5.0 %
Total aerobic microbial count (TAMC)≤ 100 CFU/g
Total combined yeasts/moulds count (TYMC)≤ 100 CFU/g
Bile-tolerant gram-negative bacteria (absent in 1 g)passes test
Candida albicans (absent in 1 g)passes test
Escherichia coli (absent in 1 g)passes test
Pseudomonas aeruginosa (absent in 1 g)passes test
Salmonella (absent in 10 g)passes test
Staphylococcus aureus (absent in 1 g)passes test
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, BP, USP.
1 g of Vitamin E dry powder = 227,5 mg of α-Tocopherol equivalent (USP)
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, BP, USP
Global Trade Item Number
产品目录编号 GTIN
5.00859.2500 04022536257037

Documentation

Material Qualification Dossier

标题版本
5.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

维生素 E 干粉(100 g 物质中含 50 g 生育酚乙酸酯) MSDS

职位

物料安全数据表 (MSDS) 

维生素 E 干粉(100 g 物质中含 50 g 生育酚乙酸酯) 分析证书

产品货号 包装规格批号
5.00859.2500 塑胶瓶PDF文档规格

证书

标题