Parteck® ODT, EMPROVE® ESSENTIAL, SAFC®

Lieferant: MERCK PRODUCTION CHEMICALS

1.00490.9025EA 0 EUR
1.00490.9025
Parteck® ODT, EMPROVE® ESSENTIAL, SAFC®
Parteck®

Parteck® ODT is a superior directly compressible excipient for fast disintegrating oral preparations. These solid dosage forms rapidly disintegrate on contact with saliva, thus eliminating the need for water and the difficulties some consumers have with swallowing tablets. This fast disintegration is a prerequisite for rapid dissolution of the active ingredients.

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Spezifikation Testergebnisse

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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