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Merck - 1004909025 - PARTECK ODT SUITABLE F (25KG) (Each)

  • MFR SKU: 1004909025
  • ITEM #: 19003565
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ITEM #: 19003565
Parteck* ODT suitable for use as excipient EMPROVE* exp^ 25kg
This listing is for Each

Merck - 1004909025 - PARTECK ODT SUITABLE F (25KG) (Each)

  • Item #: 19003565
  • MFR SKU: 1004909025
  • Catalogue Number 100490
  • HS Code 3824 99 93
  • Quality Level MQ500
  • Storage class 10 - 13 Other liquids and solids
  • WGK WGK 1 slightly hazardous to water
  • Disposal 3
  • 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 Store at +2° C to +30° C.
  • Identity passes 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 (*).

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