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500859 Vitamin E dry powder (50 g all-rac-α-tocopheryl acetate in 100 g substance)

EMPROVE® ESSENTIAL Ph Eur,BP,USP

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
Grade: Ph Eur,BP,USP
500859
가격 및 재고 조회
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개요

Replacement Information

주요 사양표

Grade Value
Ph Eur,BP,USP

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5.00859.2500
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      		 Plastic bottle 2.5 kg
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      Description
      Catalogue Number500859
      References
      Product Information
      GradePh Eur,BP,USP
      HS Code2106 90 90
      Quality LevelMQ500
      Applications
      Biological Information
      Physicochemical Information
      pH value7 (50 g/l, H₂O, 20 °C) (slurry)
      Bulk density360 kg/m3
      Dimensions
      Materials Information
      Toxicological Information
      Safety Information according to GHS
      Storage class10 - 13 Other liquids and solids
      WGKWGK 1 slightly hazardous to water
      Disposal3
      Relatively unreactive organic reagents should be collected in container A. If halogenated, they should be collected in container B. For solid residues use container C.
      Safety Information
      Product Usage Statements
      Storage and Shipping Information
      StorageStore at +2°C to +25°C.
      Packaging Information
      Transport Information
      Supplemental Information
      Specifications
      all-rac-α-Tocopheryl acetate content (GC, Ph Eur)50.0 - 57.5 %
      all-rac-α-Tocopheryl acetate content (GC, USP)49.0 - 57.5 %
      Identity (TLC)conforms
      Identity (GC)passes test
      Identity (wet chemistry)passes test
      Identity (optical rotation)passes test
      Optical rotation α 25/D (all-rac-α-Tocopheryl acetate)-0.01 - 0.01 °
      Heptane (HS-GC)≤ 5000 ppm
      Methanol (HS-GC)≤ 3000 ppm
      Other residual solvents (ICH Q3C)excluded by production process
      Loss on drying (130 °C, vacuum, 4 h)≤ 5.0 %
      Total aerobic microbial count (TAMC)≤ 100 CFU/g
      Total combined yeasts/moulds count (TYMC)≤ 100 CFU/g
      Bile-tolerant gram-negative bacteria (absent in 1 g)passes test
      Candida albicans (absent in 1 g)passes test
      Escherichia coli (absent in 1 g)passes test
      Pseudomonas aeruginosa (absent in 1 g)passes test
      Salmonella (absent in 10 g)passes test
      Staphylococcus aureus (absent in 1 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 (*).
      Corresponds to Ph Eur, BP, USP.
      1 g of Vitamin E dry powder = 227,5 mg of α-Tocopherol equivalent (USP)
      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, USP
      Global Trade Item Number
      카탈로그 번호 GTIN
      5.00859.2500 04022536257037

      Documentation

      Material Qualification Dossier

      TitleVersion
      5.0

      Quality Management Dossier (Open Access)

      Title

      Operational Excellence Dossier

      Title

      Vitamin E dry powder (50 g all-rac-α-tocopheryl acetate in 100 g substance) MSDS

      타이틀

      물질안전보건자료(MSDS) 

      Vitamin E dry powder (50 g all-rac-α-tocopheryl acetate in 100 g substance) Certificates of Analysis

      제품 번호 패킹스펙로트(lot) 번호
      5.00859.2500 Plastic bottlePDF 사양 문건

      Certificates

      Title