Parteck® ODT, EMPROVE® ESSENTIAL, SAFC®
1.00490.9025
:
- Pk:25 kg
- Seq:4283
- 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
:
:Ambient