| 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 |
| Al (Aluminium) |
≤ 5 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 |
| 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 (*). |
|
| Corresponds to the Ph. Eur., BP and NF. The sulfite contentconforms to the requirements according to European directive 95/2/EC. |
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