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100494 Parteck® M 100 (甘露醇)

EMPROVE® ESSENTIAL Ph Eur,BP,ChP,JP,USP,E 421

Parteck® M 100 (甘露醇) MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
CAS号: 69-65-8 EC号: 200-711-8 摩尔质量: 182.17 g/mol Hill配方: C₆H₁₄O₆ 级别: Ph Eur,BP,ChP,JP,USP,E 421
100494
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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
69-65-8200-711-8C₆H₁₄O₆182.17 g/molPh Eur,BP,ChP,JP,USP,E 421

Products

产品目录编号包装 数量 / 包装
1.00494.2500 塑胶瓶 2.5 kg
1.00494.9025 纤维纸箱 25 kg
描述
产品目录编号100494
参考
产品信息
CAS号69-65-8
EC号200-711-8
级别Ph Eur,BP,ChP,JP,USP,E 421
Hill配方C₆H₁₄O₆
Molar Mass182.17 g/mol
HS代码2905 43 00
Quality LevelMQ500
应用
生物信息
理化信息
沸点290 - 295 °C (4 hPa)
密度1.52 g/cm3 (20 °C)
燃点410 °C
熔点166 - 168 °C
pH值5.0 - 6.5 (182 g/l, H₂O, 25 °C)
容积密度400 - 500 kg/m3
溶解度213 g/l
尺寸
材料信息
毒性学信息
LD 50口服LD50 Rat 13500 mg/kg
GHS安全信息
RTECSOP2060000
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
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 dried substance)98.0 - 101.0 %
Identity (IR-spectrum)passes test
Identity (wet chemistry)passes test
Appearance of solution (13 %; water)passes test
Free acidpasses test
pH-value (10 %; water)4.5 - 7.5
Melting point166 - 169
Spec. rotation (α 25/D; 1 %; molybdate complex, calc. on anhydrous substance)137 - 145 °
Conductivity (25°C) (20 %; water)≤ 20
Arsenic (As)≤ 2
Ni (Nickel) (#)≤ 1
Pb (Lead)≤ 0.5
Chloride (Cl)≤ 0.003 %
Sulfate (SO₄)≤ 0.01 %
Heavy metals (as Pb)≤ 5 ppm
Oxalate (C₂O₄)≤ 0.02 %
Related substances (HPLC) (Sorbitol (Impurity A))≤ 2.0 %
Related substances (HPLC) (Sum of Maltitol and Isomalt (Impurities B and C))≤ 2.0
Related substances (HPLC) (Major unspecified impurity)≤ 0.10 %
Residual solvents (ICH Q3C)excluded by manufacturing process
Related substances (HPLC) (Sum of all impurities)≤ 2.0 %
Reducing sugars after hydrolysis/total sugar (as glucose)≤ 1
Reducing sugars (as glucose)≤ 0.05
Sulfated ash≤ 0.1
Loss on Drying (105 °C)≤ 0.5
Water≤ 0.5 %
Particle size (> 212 µm)≤ 20 %
Microbiological testpasses test
Colony count (aerobic bacteria (TAMC))≤ 10³
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., ChP, BP, JP, USP, E 421
Conforms to the purity criteria on food additives according to the current European Commission Regulation.
Corresponds to Ph. Eur., ChP, BP, JP, USP, E 421
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
1.00494.2500 04027269048778
1.00494.9025 04027269146832

Documentation

Material Qualification Dossier

标题版本
10.1

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Parteck® M 100 (甘露醇) MSDS

职位

物料安全数据表 (MSDS) 

Parteck® M 100 (甘露醇) 分析证书

产品货号 包装规格批号
1.00494.2500 塑胶瓶PDF文档规格
1.00494.9025 纤维纸箱PDF文档规格

证书

标题