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100661 工业硬脂酸

概述

Replacement Information

重要规格表

CAS #摩尔质量级别值
67701-03-5284.48 g/molPh Eur,BP,JP,NF

Products

产品目录编号包装 数量 / 包装
1.00661.0250 塑胶瓶 250 g
1.00661.9020 纤维纸箱 20 kg
描述
产品目录编号100661
描述Parteck® LUB STA 50
参考
产品信息
CAS号67701-03-5
级别Ph Eur,BP,JP,NF
Molar Mass284.48 g/mol
HS代码3823 11 00
结构配方图像结构配方图像
Quality LevelMQ500
应用
生物信息
理化信息
沸点370 °C (1013 hPa)
燃点395 °C
蒸汽压力<0.01 hPa (20 °C)
容积密度400 - 500 kg/m3
尺寸
材料信息
毒性学信息
LD 50口服LD50 Rat > 5000 mg/kg
LD 50皮下注射LD50 Rabbit > 5000 mg/kg
GHS安全信息
储存类别10 - 13 其它液体及固体
WGKNWG 没有使水遭到危害
安全信息
产品使用声明
储存和货运信息
储存于 +15°C 到 +25°C储存.
包装信息
运输信息
补充信息
规格
Stearic acid (GC)40.0 - 60.0 %
Assay (Stearic acid and palmitinic acid) (GC)≥ 90.0 %
Identity (IR)passes test
Identity (Solidification point)passes test
Identity (acid value)passes test
Identity (GC)passes test
Appearance of melt (Ph Eur, BP)passes test
Color of solution (NF)passes test
Aciditypasses test
Solidification point53 - 59 °C
Heavy metals (as Pb)≤ 20 ppm
Ni (Nickel)*≤ 1 ppm
Residual solvents (ICH Q3C)excluded by production process
Iodine number≤ 4.0
Acid value194 - 212
Sulfated ash≤ 0.1 %
Particle Size (d10)≥ 5 µm
Particle Size (d50)15 - 45 µm
Particle Size (d90)≤ 200 µm
Specific surface area (BET, volumetric)0.90 - 1.40 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)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
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, JP, NF
Global Trade Item Number
产品目录编号 GTIN
1.00661.0250 04027269028299
1.00661.9020 04022536757650

Documentation

Material Qualification Dossier

标题版本
9.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

工业硬脂酸 MSDS

职位

物料安全数据表 (MSDS) 

工业硬脂酸 分析证书

产品货号 包装规格批号
1.00661.0250 塑胶瓶PDF文档规格
1.00661.9020 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