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100490 Parteck® ODT

EMPROVE® ESSENTIAL

Parteck® ODT MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
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100490
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1004901000
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      		 Plastic bottle 1 kg
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      1004909025
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          		 Fibre carton 25 kg
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          Description
          Catalogue Number100490
          References
          Product Information
          HS Code3824 99 89
          Quality SegmentMQ500
          Applications
          Biological Information
          Physicochemical Information
          Dimensions
          Materials Information
          Toxicological Information
          Safety Information according to GHS
          Storage class10 - 13 Other liquids and solids
          WGKWGK 1 slightly hazardous to water
          Disposal3
          Relatively unreactive organic reagents should be collected in container A. If halogenated, they should be collected in container B. For solid residues use container C.
          Safety Information
          Product Usage Statements
          Storage and Shipping Information
          StorageStore at +2°C to +30°C.
          Packaging Information
          Transport Information
          Supplemental Information
          Specifications
          Identitypasses test
          Appearance (description)fine powder
          Appearance (color)white
          Assay (mannitol)90.0 - 95.0 %
          Assay (Croscarmellose-Sodium)3.0 - 7.0 %
          Ni (Nickel)*≤ 0.0001 %
          Heavy metals (as Pb)≤ 0.0005 %
          Ethanol (HS-GC)≤ 5000 ppm
          Other residual solvents (ICH Q3C)excluded by manufacturing process
          Water (according to Karl Fischer)≤ 2 %
          Microbiological purity (Total aerobic microbial count (TAMC))≤ 2000 CFU/g
          Microbiological purity (Total yeast and mould count (TYMC))≤ 200 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
          Particle size (laser diffraction) (d10)30 - 90 µm
          Particle size (laser diffraction) (d50)80 - 220 µm
          Particle size (laser diffraction) (d90)170 - 520 µm
          The Mannit and Croscarmellose-Na used for the production correspond to Ph Eur, USP/NF and JP.
          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 (*).
          Global Trade ITEM Number
          Catalogue Number GTIN
          1004901000 04027269144531
          1004909025 04027269144548

          Documentation

          Material Qualification Dossier

          TitleVersion
          9.0

          Quality Management Dossier (Open Access)

          Title

          Operational Excellence Dossier

          Title

          Parteck® ODT SDS

          Title

          Safety Data Sheet (SDS) 

          Parteck® ODT Certificates of Analysis

          Product Number PackagingSpecificationLot Number
          1004901000 Plastic bottlePDF Specification Document
          1004909025 Fibre cartonPDF Specification Document

          Certificates

          Title