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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
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Key Spec Table

Grade Value
Ph Eur,BP,USP

Pricing & Availability

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5008592500
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      		 Plastic bottle 2.5 kg
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      5008599029
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          		 Double PE Sack 25 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
          Catalogue Number GTIN
          5008592500 04022536257037
          5008599029 04022536938844

          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) SDS

          Title

          Safety Data Sheet (SDS) 

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

          Product Number PackagingSpecificationLot Number
          5008592500 Plastic bottlePDF Specification Document
          5008599029 Double PE SackPDF Specification Document

          Certificates

          Title