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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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                      Description
                      Catalogue Number100490
                      Product Information
                      HS Code3824 99 89
                      Quality LevelMQ500
                      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.
                      Storage and Shipping Information
                      StorageStore at +2°C to +30°C.
                      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
                      CO1E1004901000 0
                      CO1E1004909025 04061839008854
                      CO1I1004901000 0