100490 Parteck® ODT

100490
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      Overview

      Replacement Information

      Key Specifications Table

      Pricing & Availability

      Catalog Number AvailabilityPackaging Qty/Pack Price Quantity
      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 93
              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
              StorageStorage temperature: no restrictions.
              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 (*).

              Documentation

              Material Qualification Dossier

              Title

              Quality Management Dossier

              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