| Identity |
conforms |
| Glucose and fructose (TLC) |
conforms |
| Starch, dextrin and agar |
conforms |
| Sterculia gum |
conforms |
| Tannin |
conforms |
| Tragacantha |
conforms |
| Al (Aluminium) |
≤ 5 ppm |
| Ba (Barium)* |
≤ 70 ppm |
| Mn (Manganese) |
≤ 25 ppm |
| Residual solvents (ICH Q3C) |
excluded by production process |
| Ash |
≤ 4.0 % |
| Loss on Drying (105°C) |
≤ 10.0 % |
| Microbiological purity (Total aerobic microbial count (TAMC)) |
≤ 1E+03 CFU/g |
| Microbiological purity (Total yeast and mould count (TYMC)) |
≤ 1E+02 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 |
| 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 Ph Eur, BP |
|
