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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

Pricing & Availability

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1006630250
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      		 Plastic bottle 250 g
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      1006639020
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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
          1006630250 04027269027919
          1006639020 04022536742151

          Documentation

          Material Qualification Dossier

          TitleVersion
          9.0

          Quality Management Dossier (Open Access)

          Title

          Operational Excellence Dossier

          Title

          PARTECK LUB MST MSDS

          Title

          Safety Data Sheet (SDS) 

          PARTECK LUB MST Certificates of Analysis

          Product Number PackagingSpecificationLot Number
          1006630250 Plastic bottlePDF Specification Document
          1006639020 Fibre cartonPDF Specification Document

          Certificates

          Title

          Brochure

          Title
          Brochure: Parteck® LUB Excipient - A smooth operation