| Assay (calculated on dried substance according to Ph Eur) | 
                                98.0 - 101.0 % | 
                            
                                                                                                                                                    
                                | Assay (calculated on dried substance according to USP) | 
                                98.0 - 100.5 % | 
                            
                                                                                                                                                    
                                | Identity | 
                                passes test | 
                            
                                                                                                                                                    
                                | Appearance of solution | 
                                passes test | 
                            
                                                                                                                                                    
                                | In water insoluble matter | 
                                ≤ 0.3 % | 
                            
                                                                                                                                                    
                                | pH-value (5 %; water) | 
                                8.9 - 9.2 | 
                            
                                                                                                                                                    
                                | Chloride (Cl) | 
                                ≤ 0.005 % | 
                            
                                                                                                                                                    
                                | Sulfate (SO₄) | 
                                ≤ 0.02 % | 
                            
                                                                                                                                                    
                                | Heavy metals (as Pb) | 
                                ≤ 0.001 % | 
                            
                                                                                                                                                    
                                | As (Arsenic) | 
                                ≤ 0.0002 % | 
                            
                                                                                                                                                    
                                | Fe (Iron) | 
                                ≤ 0.001 % | 
                            
                                                                                                                                                    
                                | Sodium dihydrogen phosphate (NaH₂PO₄) | 
                                ≤ 1.7 % | 
                            
                                                                                                                                                    
                                | Residual solvents (ICH Q3C) | 
                                excluded by manufacturing process | 
                            
                                                                                                                                                    
                                | Substances reducing potassium permanganate (as O) | 
                                passes test | 
                            
                                                                                                                                                    
                                | Loss on drying (130 °C) | 
                                19.5 - 21.0 % | 
                            
                                                                                                                                                    
                                | 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, USP | 
                                 |