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100661 Parteck® LUB STA 50

New100661
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Overview

Replacement Information

Key Specifications Table

CAS #Molar MassGrade Value
67701-03-5 284.48 g/mol Ph Eur,BP,JP,NF

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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
          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)
          Flash point196 °C
          Ignition temperature395 °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
          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)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