مشخصات فنی محصول | |
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Appearance | faintly yellow to light yellowish-brown granular powder |
Identity (A: coloring) | passes test |
Identity (B: gelatinizing property) | passes test |
pH (10 g/l, CO₂-free water) | 3.8 - 7.6 |
Conductivity (1.0 %, 30 °C) | ≤ 1 mS/cm |
Sulfur dioxide (SO₂) | ≤ 50 ppm |
Cr (Chromium) | ≤ 10 ppm |
Fe (Iron) | ≤ 30 ppm |
Zn (Zinc) | ≤ 30 ppm |
Peroxide (as H₂O₂) | ≤ 10 ppm |
Residual solvents (ICH (Q3C)) | excluded by manufacturing process |
Bloom value (about 110) | 90 - 130 |
Loss on drying (105 °C, 16h) | ≤ 15.0 % |
Particle size (< 800 µm) | ≥ 99 % |
Total aerobic microbial count (TAMC) | ≤ 1000 CFU/g |
Total combined yeasts/moulds count (TYMC) | ≤ 100 CFU/g |
Bile-tolerant gram-negative bacteria (absent in 1 g) | passes test |
Candida albicans (absent in 1 g) | passes test |
Escherichia coli (absent in 1 g) | passes test |
Pseudomonas aeruginosa (absent in 1 g) | passes test |
Salmonella (absent in 10 g) | passes test |
Staphylococcus aureus (absent in 1 g) | passes test |
Residues of metal catalysts or metal reagents acc. to EMEA/CHMP/SWP/4446/2000 are not likely to be present. |
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Corresponds to the Ph. Eur., BP and NF. The sulfite contentconforms to the requirements according to European directive 95/2/EC. |