| Assay (HPLC, calc. on dried substance) |
98.0 - 101.0 % |
| Identity (IR-spectrum) |
passes test |
| Appearance of solution (10 %; water) |
passes test |
| pH-value (10 %; water) |
4.5 - 7.5 |
| Melting point |
165 - 169 |
| Conductivity (25°C) (20 %; water) |
≤ 20 |
| Heavy metals (as Pb) |
≤ 5 ppm |
| Ni (Nickel) |
≤ 1 ppm |
| Pb (Lead) |
≤ 0.5 ppm |
| Ru (Ruthenium) (#) |
≤ 1 ppm |
| Related substances (HPLC) (Sorbitol (Impurity A)) |
≤ 2.0 % |
| Related substances (HPLC) (Sum of Maltitol and Isomalt (Impurities B and C)) |
≤ 2.0 |
| Related substances (HPLC) (Major unspecified impurity) |
≤ 0.10 % |
| Related substances (HPLC) (Sum of all impurities) |
≤ 2.0 % |
| Reducing sugars (as glucose) |
≤ 0.05 |
| Reducing sugars after hydrolysis/total sugar (as glucose) |
≤ 1 |
| Sulfated ash |
≤ 0.1 |
| Water |
≤ 0.5 |
| Loss on Drying (105°C) |
≤ 0.30 % |
| Residual solvents (ICH Q3C) |
excluded by manufacturing process |
| Microbiological test |
passes test |
| Colony count (aerobic bacteria (TAMC)) |
≤ 10² |
| Colony count (Yeasts and moulds (TYMC)) |
≤ 10² |
| Salmonella species |
In 10g substance not detectable |
| E.coli |
In 1g substance not detectable |
| Staphylococcus aureus |
In 1g substance not detectable |
| Pseudomonas aeruginosa |
In 1g substance not detectable |
| Candida albicans |
In 1g substance not detectable |
| Endotoxins (kinetic turbidimetric test) |
≤ 1 |
| 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, JP |
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