Résultats des tests de spécification
Assay (Compl.) (calc. A.A.S) |
99.0 - 100.5% |
Identity: Identity according to Pharmacopoeias |
Passes Test |
pH of 5% Solution |
5.0 - 9.2 |
Appearance of solution |
Passes Test |
Maximum Limit of Impurities, Acidity or Alkalinity |
Passes Test |
Maximum Limit of Impurities, Insoluble Matter In H₂O |
0.025 % |
Maximum Limit of Impurities, Loss on Drying at 450°C |
48.0 - 52.0 % |
Maximum Limit of Impurities, Chloride (Cl) |
0.014% |
Maximum Limit of Impurities, Ammonium (NH₄) |
0.005% |
Maximum Limit of Impurities, Phosphate (PO₄) |
0.002 % |
Maximum Limit of Impurities, Residual Solvents (Ph. Eur./USP) |
passes test |
Maximum Limit of Impurities, Heavy Metals (as Pb) |
0.001% |
Maximum Limit of Impurities, Fe |
0.002 % |
Maximum Limit of Impurities, Se |
0.0015 % |
Maximum Limit of Impurities, As |
0.00015 % |
Elemental Impurities (ICH Q3D), Class 1, Cd |
0.5 ppm |
Elemental Impurities (ICH Q3D), Class 1, Pb |
50 ppm |
Elemental Impurities (ICH Q3D), Class 1, As |
1.5 ppm |
Elemental Impurities (ICH Q3D), Class 1, Hg |
1.5 ppm |
Elemental Impurities (ICH Q3D), Class 2A, Co |
5 ppm |
Elemental Impurities (ICH Q3D), Class 2A, V |
10 ppm |
Elemental Impurities (ICH Q3D), Class 2A, Ni |
20 ppm |
Elemental Impurities (ICH Q3D), Class 2B, Au |
10 ppm |
Elemental Impurities (ICH Q3D), Class 2B, Pd |
10 ppm |
Elemental Impurities (ICH Q3D), Class 2B, Ir |
10 ppm |
Elemental Impurities (ICH Q3D), Class 2B, Os |
10 ppm |
Elemental Impurities (ICH Q3D), Class 2B, Rh |
10 ppm |
Elemental Impurities (ICH Q3D), Class 2B, Ru |
10 ppm |
Elemental Impurities (ICH Q3D), Class 2B, Se |
15 ppm |
Elemental Impurities (ICH Q3D), Class 2B, Ag |
15 ppm |
Elemental Impurities (ICH Q3D), Class 2B, Pt |
10 ppm |
Elemental Impurities (ICH Q3D), Class 3, Li |
55 ppm |
Elemental Impurities (ICH Q3D), Class 3, Sb |
120 ppm |
Elemental Impurities (ICH Q3D), Class 3, Ba |
140 ppm |
Elemental Impurities (ICH Q3D), Class 3, Mo |
25 ppm |
Elemental Impurities (ICH Q3D), Class 3, Cu |
250 ppm |
Elemental Impurities (ICH Q3D), Class 3, Sn |
600 ppm |
Elemental Impurities (ICH Q3D), Class 3, Cr |
25 ppm |