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100663 PARTECK LUB MST

(MAGNESIUM STEARATE VEGETABLE GRADE) EMPROVE® ESSENTIAL Ph Eur,BP,JP,NF,FCC

PARTECK LUB MST MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
CAS #: 557-04-0 EC Number: 209-150-3 Molar Mass: 591.24 g/mol Hill Formula: C₃₆H₇₀Mg O₄ Grade: Ph Eur,BP,JP,NF,FCC
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100663
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Overview

Replacement Information

Key Spec Table

CAS #EC NumberHill FormulaMolar MassGrade Value
557-04-0209-150-3C₃₆H₇₀Mg O₄591.24 g/molPh Eur,BP,JP,NF,FCC

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      		 Fibre carton 20 kg
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      Description
      Catalogue Number100663
      References
      Product Information
      CAS number557-04-0
      EC number209-150-3
      GradePh Eur,BP,JP,NF,FCC
      Hill FormulaC₃₆H₇₀Mg O₄
      Molar Mass591.24 g/mol
      HS Code3824 99 89
      Structure formula ImageStructure formula Image
      Quality LevelMQ500
      Applications
      Biological Information
      Physicochemical Information
      Melting Point140 °C
      pH value7 (H₂O) (slurry)
      Bulk density250 kg/m3
      Dimensions
      Materials Information
      Toxicological Information
      LD 50 oralLD50 Rat > 2000 mg/kg
      Safety Information according to GHS
      RTECSWI4390000
      Storage class10 - 13 Other liquids and solids
      WGKNWG not water endangering
      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 +30°C.
      Packaging Information
      Transport Information
      Supplemental Information
      Specifications
      Assay (Mg; calculated on dried substance)4.0 - 5.0 %
      Identity (GC)passes test
      Identity (Solidification point)passes test
      Identity (Magnesium)passes test
      Identity (acid value)195 - 210
      Palmitic- stearic acid components of fatty acids≥ 95 %
      Stearic acid component of fatty acids60 - 70 %
      Acidity or alkalinitypasses test
      Chloride (Cl)≤ 0.1 %
      Sulfate (SO₄)≤ 0.3 %
      Heavy metals (as Pb)≤ 20 ppm
      Al (Aluminium)≤ 50 ppm
      Cd (Cadmium)≤ 0.2 ppm
      Fe (Iron)≤ 100 ppm
      Mn (Manganese)≤ 25 ppm
      Ni (Nickel)*≤ 2 ppm
      Pb (Lead)≤ 0.5 ppm
      V (Vanadium)*≤ 2 ppm
      Zn (Zinc)≤ 20 ppm
      Residual solvents (ICH Q3C)excluded by the production process
      Loss on Drying (105 °C)≤ 4.0 %
      Particle Size (d10)≥ 1 µm
      Particle Size (d50)3 - 7 µm
      Particle Size (d90)≤ 30 µm
      Specific surface area (BET, volumetric)5 - 12 m²/g
      Microbiological purity (Total aerobic microbial count (TAMC))≤ 1E+03 CFU/g
      Microbiological purity (Total yeast and mould count (TYMC))≤ 1E+02 CFU/g
      Bile tolerant Gram negative Bacteria (absent in 1 g)passes test
      Escherichia coli (absent in 1 g)passes test
      Pseudomonas aeruginosa (absent in 1 g)passes test
      Staphylococcus aureus (absent in 1 g)passes test
      Candida albicans (absent in 1 g)passes test
      Salmonella ssp (absent in 10 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, JP, NF, FCC
      Global Trade Item Number
      Catalogue Number GTIN
      1006639020 04022536742151

      Documentation

      Material Qualification Dossier

      TitleVersion
      9.0

      Quality Management Dossier (Open Access)

      Title

      Operational Excellence Dossier

      Title

      PARTECK LUB MST SDS

      Title

      Safety Data Sheet (SDS) 

      PARTECK LUB MST Certificates of Analysis

      Product Number PackagingSpecificationLot Number
      1006639020 Fibre cartonPDF Specification Document

      Certificates

      Title

      Brochure

      Title
      Brochure: Parteck® LUB Excipient - A smooth operation