100661 Parteck® LUB STA 50

100661
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      Overview

      Replacement Information

      Key Specifications Table

      Molar MassGrade Value
      284.48 g/mol Ph Eur,BP,JP,NF

      Pricing & Availability

      Catalog Number AvailabilityPackaging Qty/Pack Price Quantity
      1006610250
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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
              GradePh Eur,BP,JP,NF
              Molar Mass284.48 g/mol
              HS Code3823 11 00
              Structure formula ImageStructure formula Image
              Applications
              Biological Information
              Physicochemical Information
              Boiling point370 °C (1013 hPa)
              Flash point196 °C
              Ignition temperature395 °C
              Melting Point68 - 70 °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
              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 %
              Identitypasses 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)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

              Documentation

              Material Qualification Dossier

              Title

              Quality Management Dossier

              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
              1006610250 Plastic bottlePDF Specification Document
              1.00661.9020 Fibre cartonPDF Specification Document

              Certificates

              Title

              Brochure

              Title
              MultiPharmTM Minerals for Solid Dosage Forms