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100663 硬脂酸镁(含软脂酸镁)

硬脂酸镁(含软脂酸镁) EMPROVE® ESSENTIAL Ph Eur,BP,ChP,JP,NF,FCC

硬脂酸镁(含软脂酸镁) MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
CAS号: 557-04-0 EC号: 209-150-3 摩尔质量: 591.24 g/mol Hill配方: C₃₆H₇₀Mg O₄ 级别: Ph Eur,BP,ChP,JP,NF,FCC
100663
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概述

Replacement Information

重要规格表

CAS #EC号Hill配方摩尔质量级别值
557-04-0209-150-3C₃₆H₇₀Mg O₄591.24 g/molPh Eur,BP,ChP,JP,NF,FCC

Products

产品目录编号包装 数量 / 包装
1.00663.0250 塑胶瓶 250 g
1.00663.9020 纤维纸箱 20 kg
描述
产品目录编号100663
参考
产品信息
CAS号557-04-0
EC号209-150-3
级别Ph Eur,BP,ChP,JP,NF,FCC
Hill配方C₃₆H₇₀Mg O₄
Molar Mass591.24 g/mol
HS代码3824 99 89
结构配方图像结构配方图像
Quality LevelMQ500
应用
生物信息
理化信息
熔点140 °C
pH值7 (H₂O) (残渣)
容积密度250 kg/m3
尺寸
材料信息
毒性学信息
LD 50口服LD50 Rat > 2000 mg/kg
GHS安全信息
RTECSWI4390000
储存类别10 - 13 其它液体及固体
WGKNWG 没有使水遭到危害
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
Assay (Mg; calculated on dried substance)4.0 - 5.0 %
Assay (Mg; calculated on dried substance) (ChP)4.0 - 5.0 %
Identity (GC)passes test
Identity (Solidification point)passes test
Identity (wet chemistry)passes test
Identity (acid value)195 - 210
Palmitic- stearic acid components of fatty acids≥ 95 %
Stearic acid component of fatty acids60 - 70 %
Acidity or alkalinitypasses test
Chloride (Cl)≤ 0.10 %
Sulfate (SO₄)≤ 0.3 %
Heavy metals (as Pb)≤ 10 ppm
Al (Aluminium)≤ 50 ppm
Cd (Cadmium)≤ 0.2 ppm
Fe (Iron)≤ 100 ppm
Mn (Manganese)≤ 25 ppm
Ni (Nickel)*≤ 2 ppm
Pb (Lead)≤ 0.5 ppm
V (Vanadium)*≤ 2 ppm
Zn (Zinc)≤ 20 ppm
Residual solvents (ICH Q3C)excluded by the production process
Loss on Drying (105 °C)≤ 4.0 %
Loss on Drying (ChP)≤ 5.0 %
Particle Size (d10)≥ 1 µm
Particle Size (d50)3 - 7 µm
Particle Size (d90)≤ 30 µm
Specific surface area (BET, volumetric)5 - 12 m²/g
Microbiological purity (Total aerobic microbial count (TAMC))≤ 1E+03 CFU/g
Microbiological purity (Total yeast and mould count (TYMC))≤ 1E+02 CFU/g
Bile tolerant Gram negative Bacteria (absent in 1 g)passes test
Escherichia coli (absent in 1 g)passes test
Pseudomonas aeruginosa (absent in 1 g)passes test
Staphylococcus aureus (absent in 1 g)passes test
Candida albicans (absent in 1 g)passes test
Salmonella ssp (absent in 10 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, ChP, JP, NF, FCC
Global Trade Item Number
产品目录编号 GTIN
1.00663.0250 04027269027919
1.00663.9020 04022536742151

Documentation

Material Qualification Dossier

标题版本
9.1

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

硬脂酸镁(含软脂酸镁) MSDS

职位

物料安全数据表 (MSDS) 

硬脂酸镁(含软脂酸镁) 分析证书

产品货号 包装规格批号
1.00663.0250 塑胶瓶PDF文档规格
1.00663.9020 纤维纸箱PDF文档规格

证书

标题

小册子

标题
Brochure: Parteck® LUB Excipient - A smooth operation