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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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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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1006630250
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      1006639020
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          CO1E1006639020
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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
              CO1E1006639020 04061839008953

              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
              1006630250 Plastic bottlePDF Specification Document
              1006639020 Fibre cartonPDF Specification Document
              CO1E1006639020 PDF Specification Document

              Certificates

              Title

              Brochure

              Title
              Brochure: Parteck® LUB Excipient - A smooth operation