Specifications | |
---|---|
Purity (HPLC) | ≥ 98.0 % |
Identity (IR) | conforms |
Spec. rotation [α²0/D (10 %; water; calc. on anhydrous substance) | +135 - +139 ° |
N (Nitrogen) | ≤ 0.1 % |
Heavy metals (as Pb) | ≤ 0.001 % |
Fe (Iron) | ≤ 0.0005 % |
Methanol (HS-GC) | ≤ 3000 ppm |
Residual solvents class 3 (Ph. Eur./ICH) | ≤ 0.5 % |
Other residual solvents (Ph. Eur./ICH) | excluded by production process |
Glucose (HPLC) | ≤ 0.5 % |
Sulfated ash | ≤ 0.1 % |
Water | 5.0 - 5.5 % |