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141350 聚乙烯醇 4-88

概述

Replacement Information

重要规格表

CAS #Hill配方级别值
9002-89-5(C₂H₄O)nPh Eur,ChP,USP,JPE

价格及供货情况

产品目录编号 库存情况包装 数量 / 包装 价格 数量
1.41350.1000
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      塑胶瓶 1 kg
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      描述
      产品目录编号141350
      同义词PVA, PVOH
      参考
      产品信息
      CAS号9002-89-5
      级别Ph Eur,ChP,USP,JPE
      Hill配方(C₂H₄O)n
      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)3.4 - 4.6 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, ChP)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
      1.41350.1000 04027269063689

      Documentation

      Material Qualification Dossier

      标题版本
      10.0

      Quality Management Dossier (Open Access)

      Title

      Operational Excellence Dossier

      Title

      聚乙烯醇 4-88 MSDS

      职位

      物料安全数据表 (MSDS) 

      聚乙烯醇 4-88 分析证书

      产品货号 包装规格批号
      1.41350.1000 塑胶瓶PDF文档规格

      证书

      标题

      技术信息

      标题
      Use of Polyvinyl Alcohol as an effective Binder in Continuous Twin-Screw Granulation

      相关产品和应用

      种类

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      Biopharmaceutical Manufacturing > Formulation > Liquid Dosage > Surfactants and Stabilizers
      Small Molecule Pharmaceuticals > Formulation > Semisolid Dosage Form > Thickeners
      Small Molecule Pharmaceuticals > Formulation > Liquid Dosage Form > Thickeners
      Small Molecule Pharmaceuticals > Formulation > Solid Dosage Form > Binders and Fillers
      Small Molecule Pharmaceuticals > Formulation > Solid Dosage Form > Coatings
      Small Molecule Pharmaceuticals > Formulation > Liquid Dosage Form > Surfactants and Stabilizers