Parteck® ODT, EMPROVE® ESSENTIAL, SAFC®
Lieferant: MERCK PRODUCTION CHEMICALS
1.00490.9025EA
0
CHF
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.
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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