| Assay (calc. on anhydrous substance) |
97.5 - 102.0 % |
| Identity (IR) |
passes test |
| Identity (spec. rotation calc. on anhydrous substance) |
passes test |
| Identity (HPLC) |
passes test |
| Identity (water) |
passes test |
| Appearance of solution |
passes test |
| Color and clarity of solution |
passes test |
| Conductivity |
≤ 20 µS/cm |
| Heavy metals (as Pb) |
≤ 5 ppm |
| Cu (Copper) |
≤ 0.0025 % |
| Zn (Zinc) |
≤ 0.0025 % |
| Related substances [sum of impurities A (maltose) and B (isomaltose)! |
≤ 0.4 % |
| Related substances [Impurity C (maltotriose)! |
≤ 0.2 % |
| Related substances [Impurity D (fructose)! |
≤ 0.15 % |
| Related substances (unspecified impurities) |
≤ 0.10 % |
| Related substances (Sum of all impurities) |
≤ 0.5 % |
| Dextrin |
passes test |
| Soluble starch, sulfite |
≤ 15 ppm |
| Residual solvents (ICH Q3C) |
excluded by manucaturing process |
| Water (according to Karl Fischer) |
7.5 - 9.5 % |
| Endotoxins |
≤ 2.5 I.U./g |
| Microbiological purity (Total aerobic microbial count (TAMC)) |
≤ 1000 CFU/g |
| Microbiological purity (Total yeast and mould count (TYMC)) |
≤ 100 CFU/g |
| Gram negative Bacteria (absent in 1 g) |
passes test |
| Escherichia coli (absent in 1 g) |
passes test |
| Pseudomonas aeruginosa (absent in 1 g) |
passes test |
| Staphylococcus aureus (absent in 1 g) |
passes test |
| Candida albicans (absent in 1 g) |
passes test |
| Salmonella ssp (absent in 10 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 Ph Eur, BP, USP |
|
