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141353 聚乙烯醇 40-88

suitable for use as excipient EMPROVE® ESSENTIAL Ph Eur,ChP,USP,JPE

聚乙烯醇 40-88 MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.

同义词: PVA, PVOH

CAS号: 9002-89-5 级别: Ph Eur,ChP,USP,JPE
141353
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概述

Replacement Information

重要规格表

CAS #级别值
9002-89-5Ph Eur,ChP,USP,JPE

Products

产品目录编号包装 数量 / 包装
1.41353.1000 塑胶瓶 1 kg
1.41353.9029 双层聚乙烯袋 25 kg
描述
产品目录编号141353
同义词PVA, PVOH
参考
产品信息
CAS号9002-89-5
级别Ph Eur,ChP,USP,JPE
HS代码3905 30 00
Quality LevelMQ500
应用
生物信息
理化信息
熔点160 - 240 °C
容积密度400 - 670 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
RTECSTR8100000
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 (IR spectrum)passes test
Identity (Viscosity)passes test
Identity (Reaction with iodine)passes test
Identity (Reaction with iodine and boric acid)passes test
Identity (Reaction with ethanol)passes test
Appearance of solution (40 g/l, water)passes test
Appearance of solution (50 g/l, water)passes test
Water-insoluble matter (40 g/l, water)≤ 0.1 %
pH-Value (40 g/l; water)5.0 - 6.5
Viscosity (40 g/l; water)34.0 - 46.0 mPa∙s
As (Arsenic)≤ 2 ppm
As (Arsenic) (ChP)≤ 2 ppm
Heavy metals (as Pb)≤ 10 ppm
Heavy metals (as Pb) (ChP)≤ 10 ppm
Crotonaldehyde (GC)≤ 10 ppm
Acetic acid (alkalimetric)≤ 0.5 %
Methanol (GC)≤ 1.0 %
Methanol (GC) (JPE)¹≤ 1.0 %
Methyl acetate (GC)≤ 1.0 %
Other residual solvents (ICH Q3C)excluded by production process
Ester value130 - 150
Degree of hydrolysis (USP)85 - 89 %
Degree of hydrolysis (JPE)78 - 96 %
Acid value≤ 3.0
Saponification value132 - 152
Residue on ignition≤ 1.0 %
Sulfated ash≤ 1.0 %
Loss on Drying (105 °C)≤ 5.0 %
Microbiological purity (Total aerobic microbial count (TAMC))≤ 100 CFU/g
Microbiological purity (Total yeast and mould count (TYMC))≤ 100 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 (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 (*).
¹ Value measured in qualified external laboratory
Corresponds to Ph Eur,ChP,USP,JPE
Global Trade Item Number
产品目录编号 GTIN
1.41353.1000 04027269063740
1.41353.9029 04027269074968

Documentation

Material Qualification Dossier

标题版本
9.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

聚乙烯醇 40-88 MSDS

职位

物料安全数据表 (MSDS) 

聚乙烯醇 40-88 分析证书

产品货号 包装规格批号
1.41353.1000 塑胶瓶PDF文档规格
1.41353.9029 双层聚乙烯袋PDF文档规格

证书

标题

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