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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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Replacement Information

Key Spec Table

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

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1006610250
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      		 Plastic bottle 250 g
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      1006619020
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          		 Fibre carton 20 kg
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          CO1E1006619020
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              		 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
              1006610250 04027269028299
              1006619020 04022536757650
              CO1E1006619020 04061839008939

              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
              1006610250 Plastic bottlePDF Specification Document
              1006619020 Fibre cartonPDF Specification Document
              CO1E1006619020 PDF Specification Document

              Certificates

              Title

              Brochure

              Title
              Brochure: Parteck® LUB Excipient - A smooth operation