| Assay (alkalimetric, calculated on dried substance) |
98.0 - 100.5 % |
| Assay (alkalimetric; dried substance) |
≥ 99.0 % |
| Identity |
passes test |
| Appearance of solution |
passes test |
| Insoluble substances |
≤ 0.2 % |
| pH-value (2 %; water) |
4.2 - 4.6 |
| pH-value (5 %; water) |
4.2 - 4.5 |
| Carbonate |
passes test |
| Condensed phosphate |
passes test |
| Chloride (Cl) |
≤ 0.009 % |
| Fluoride (F) |
≤ 0.0010 % |
| Sulfate (SO₄) |
≤ 0.017 % |
| Heavy metals (as Pb) |
≤ 0.0010 % |
| Al (Aluminium) |
≤ 0.0005 % |
| As (Arsenic) |
≤ 0.0002 % |
| Fe (Iron) |
≤ 0.0010 % |
| Na (Sodium) |
≤ 0.1 % |
|
passes test |
| Pb (Lead) |
≤ 0.0004 % |
| Endotoxins |
≤ 2.5 I.U./g |
| Total aerobic microbial count |
≤ 100 CFU/g |
| Total yeast and mould count |
≤ 100 CFU/g |
| DNases (Exo- and endonucleases) (not detectable) |
passes test |
| RNases (not detectable) |
passes test |
| Proteases (not detectable) |
passes test |
| Residual solvents (ICH Q3C) |
excluded by manufacturing process |
| Reducing substances |
passes test |
| Loss on drying (105 °C) |
≤ 0.5 % |
| Loss on drying (130 °C) |
≤ 1.0 % |
| 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, JPC NF |
|
