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115079 Parteck® SI 200 （山梨醇）

EMPROVE® ESSENTIAL Ph Eur,BP,JP,NF,E 420

Parteck® SI 200 （山梨醇） MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.

同义词: D-Glucitol

摩尔质量: 182.17 g/mol 级别: Ph Eur,BP,JP,NF,E 420
115079
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概述

Replacement Information

重要规格表

摩尔质量级别值
182.17 g/molPh Eur,BP,JP,NF,E 420

Products

产品目录编号包装 数量 / 包装
1.15079.2500 塑胶瓶 2.5 kg
1.15079.9028 纤维纸箱 25 kg
描述
产品目录编号115079
同义词D-Glucitol
参考
产品信息
级别Ph Eur,BP,JP,NF,E 420
Molar Mass182.17 g/mol
HS代码2905 44 00
Quality LevelMQ500
应用
生物信息
理化信息
密度1.49 g/cm3 (20 °C)
燃点420 °C
熔点94 - 96 °C
pH值5.0 - 7 (182 g/l, H₂O, 25 °C)
蒸汽压力<0.1 hPa (25 °C)
容积密度450 kg/m3
溶解度2350 g/l
尺寸
材料信息
毒性学信息
LD 50口服LD50 Rat 15900 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
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
申报（铁路和陆路）ADR、RIDKein Gefahrgut
申报（空运）IATA-DGRNo Dangerous Good
申报（海运）IMDG-代码No Dangerous Good
补充信息
规格
Assay (HPLC, calc.on anhydrous substance)97.0 - 100.5 %
Identitypasses test
pH-value (10 %; water)3.5 - 7.0
Appearance of solution (25 %; water)passes test
Spec. rotation (α20/D, 10 %, borate complex, calc. on anhydrous substance)4.0 - 7.0 °
Conductivity (25°C) (20 %; water)≤ 20
Chloride (Cl)≤ 0.002 %
Sulfate (SO₄)≤ 0.005 %
Heavy metals (as Pb)≤ 5 ppm
As (Arsenic)≤ 1.0 ppm
Ni (Nickel) (#)≤ 1 ppm
Pb (Lead)≤ 0.5 ppm
Ru (Ruthenium) (#)≤ 1 ppm
Related substances (HPLC, Ph. Eur.) (major impurity)≤ 2.0 %
Related substances (HPLC, EP) (Sum of all impurities)≤ 3.0 %
Reducing sugars after hydrolysis/total sugar (as glucose)≤ 0.8
Reducing sugars (as glucose)≤ 0.11 %
Sulfated ash≤ 0.02 %
Loss on drying≤ 2.0 %
Water≤ 1.5 %
Particle size (< 100 µm)≤ 15 %
Particle size (> 200 µm)35 - 70 %
Particle size (> 500 µm)≤ 6 %
Residual solvents (ICH Q3C)excluded by manufacturing process
Microbiological testpasses test
Colony count (aerobic bacteria (TAMC))≤ 5*10²
Colony count (Yeasts and moulds (TYMC))≤ 10²
Salmonella spp.in 10g Substance not detectable
E.coliin 1g substance not detectable
Staphylococcus aureusin 1g substance not detectable
Pseudomonas aeruginosain 1g substance not detectable
Candida albicansIn 1g substance not detectable
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, E 420
Conforms to the purity criteria on food additives according to the current European Commission Regulation.
Global Trade Item Number
产品目录编号 GTIN
1.15079.2500 04027269130855
1.15079.9028 04022536936475

Documentation

Material Qualification Dossier

标题版本
9.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Parteck® SI 200 （山梨醇） MSDS

职位

物料安全数据表 (MSDS) 

Parteck® SI 200 （山梨醇） 分析证书

产品货号 包装规格批号
1.15079.2500 塑胶瓶PDF文档规格
1.15079.9028 纤维纸箱PDF文档规格

证书

标题