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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

Pricing & Availability

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1.00661.0250
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      		 Plastic bottle 250 g
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      1.00661.9020
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          		 Fibre carton 20 kg
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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
          1.00661.9020 04022536757650

          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
          1.00661.9020 Fibre cartonPDF Specification Document

          Certificates

          Title

          Brochure

          Title
          Brochure: Parteck® LUB Excipient - A smooth operation