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108197 药片辅助剂 K（纤维素粉）

EMPROVE® ESSENTIAL Ph Eur,BP,JP,NF

药片辅助剂 K（纤维素粉） MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
CAS号: 9004-34-6 EC号: 232-674-9 化学配方: (C₆H₁₀O₅)n 级别: Ph Eur,BP,JP,NF
108197
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概述

Replacement Information

重要规格表

CAS #EC号化学配方级别值
9004-34-6232-674-9(C₆H₁₀O₅)nPh Eur,BP,JP,NF

Products

产品目录编号包装 数量 / 包装
1.08197.9020 塑胶滚桶;塑胶鼓桶 20 kg
描述
产品目录编号108197
参考
产品信息
CAS号9004-34-6
EC号232-674-9
级别Ph Eur,BP,JP,NF
化学配方(C₆H₁₀O₅)n
HS代码3912 90 90
Quality LevelMQ500
应用
生物信息
理化信息
密度1.5 g/cm3 (20 °C)
燃点232 °C
pH值5 - 7.5 (100 g/l, H₂O, 20 °C) (残渣)
容积密度70 - 400 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 > 2000 mg/kg
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 +15°C 到 +25°C储存.
包装信息
运输信息
补充信息
规格
Identity (wet chemistry)passes test
Identity (suspension test)passes test
Identity (degree of polymerization)440 - 2250
Ether-soluble substances≤ 0.15 %
Water-soluble substances≤ 1.5 %
Solubilitypasses test
pH-value5.0 - 7.5
Al (Aluminium)≤ 10 ppm
Organic impuritiespasses test
Residual solvents (ICH Q3C)excluded by production process
Bulk density0.070 - 0.100 g/cm³
Sulfated ash≤ 0.3 %
Loss on Drying (105 °C)≤ 6.0 %
Particle size (> 32 µm)≤ 90 %
Particle size (> 90 µm)≤ 35 %
Particle size (> 400 µm)≤ 1 %
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 (*).
Conforms to the purity criteria on food additives according to the current European Commission Regulation.
Corresponds to Ph Eur, BP, JP, NF
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 (*).
Conforms to the purity criteria on food additives according to the current European Commission Regulation.
Corresponds to Ph Eur, BP, JP, NF
Global Trade Item Number
产品目录编号 GTIN
1.08197.9020 04022536101576

Documentation

Material Qualification Dossier

标题版本
9.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

药片辅助剂 K（纤维素粉） MSDS

职位

物料安全数据表 (MSDS) 

药片辅助剂 K（纤维素粉） 分析证书

产品货号 包装规格批号
1.08197.9020 塑胶滚桶;塑胶鼓桶PDF文档规格

证书

标题