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100661 Parteck® LUB STA 50

(Stearic acid 50 vegetable grade) EMPROVE® ESSENTIAL Ph Eur,BP,JP,NF

Parteck® LUB STA 50 MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
CAS #: 67701-03-5 Molar Mass: 284.48 g/mol Grade: Ph Eur,BP,JP,NF
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100661
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Key Spec Table

CAS #Molar MassGrade Value
67701-03-5284.48 g/molPh Eur,BP,JP,NF

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      		 Plastic bottle 250 g
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      Description
      Catalogue Number100661
      DescriptionParteck® LUB STA 50
      References
      Product Information
      CAS number67701-03-5
      GradePh Eur,BP,JP,NF
      Molar Mass284.48 g/mol
      HS Code3823 11 00
      Structure formula ImageStructure formula Image
      Quality LevelMQ500
      Applications
      Biological Information
      Physicochemical Information
      Boiling point370 °C (1013 hPa)
      Ignition temperature395 °C
      Vapor pressure<0.01 hPa (20 °C)
      Bulk density400 - 500 kg/m3
      Dimensions
      Materials Information
      Toxicological Information
      LD 50 oralLD50 Rat > 5000 mg/kg
      LD 50 dermalLD50 Rabbit > 5000 mg/kg
      Safety Information according to GHS
      Storage class10 - 13 Other liquids and solids
      WGKNWG not water endangering
      Safety Information
      Product Usage Statements
      Storage and Shipping Information
      StorageStore at +15°C to +25°C.
      Packaging Information
      Transport Information
      Supplemental Information
      Specifications
      Stearic acid (GC)40.0 - 60.0 %
      Assay (Stearic acid and palmitinic acid) (GC)≥ 90.0 %
      Identity (IR)passes test
      Identity (Solidification point)passes test
      Identity (acid value)passes test
      Identity (GC)passes test
      Appearance of melt (Ph Eur, BP)passes test
      Color of solution (NF)passes test
      Aciditypasses test
      Solidification point53 - 59 °C
      Heavy metals (as Pb)≤ 20 ppm
      Ni (Nickel)*≤ 1 ppm
      Residual solvents (ICH Q3C)excluded by production process
      Iodine number≤ 4.0
      Acid value194 - 212
      Sulfated ash≤ 0.1 %
      Particle Size (d10)≥ 5 µm
      Particle Size (d50)15 - 45 µm
      Particle Size (d90)≤ 200 µm
      Specific surface area (BET, volumetric)0.90 - 1.40 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)conforms
      Escherichia coli (absent in 1 g)conforms
      Pseudomonas aeruginosa (absent in 1 g)conforms
      Staphylococcus aureus (absent in 1 g)conforms
      Candida albicans (absent in 1 g)conforms
      Salmonella ssp (absent in 10 g)conforms
      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
      Global Trade Item Number
      Catalogue Number GTIN
      1.00661.0250 04027269028299

      Documentation

      Material Qualification Dossier

      TitleVersion
      9.0

      Quality Management Dossier (Open Access)

      Title

      Operational Excellence Dossier

      Title

      Parteck® LUB STA 50 SDS

      Title

      Safety Data Sheet (SDS) 

      Parteck® LUB STA 50 Certificates of Analysis

      Product Number PackagingSpecificationLot Number
      1.00661.0250 Plastic bottlePDF Specification Document

      Certificates

      Title

      Brochure

      Title
      Brochure: Parteck® LUB Excipient - A smooth operation