Description

• General description: Our SAFC® portfolio of high-quality raw materials for use in biopharmaceutical processing withstands strict quality control procedures plus the documentation and expertise to help our customers meet requirements as defined by the M-Clarity Program.M-Clarity ProgramOur comprehensive portfolio of upstream process chemicals not only provides biopharmaceutical manufacturers with high-quality raw materials for production of classical and novel therapies, but also helps them get to market faster and simplify regulatory challenges. Trust us to deliver supply chain transparency and reliable sourcing around the globe, streamlining your product qualification with best-in-class regulatory support and service.
• Analysis Note: Assay (ex N, calc. on dried substance): 98.5 - 101.5 %Identity (IR-spectrum): passes testAppearance: white to almost white, fine-crystalline powderAppearance of solution (100 g/l, hydrochloric acid  2 mol/l): clear and colorlessSpec. rotation (α 20/D, 20 g/l, hydrochloric acid 1 mol/l, previously dried substance): -215 to -225Heavy metals (as Pb): ≤ 10 ppmPb (Lead): ≤ 5 ppmNinhydrin - positive substances (LC) (largest single impurity): ≤ 0.2 %Ninhydrin - positive substances (LC) (Sum of all impurities): ≤ 0.5 %Sulfated ash (800 °C): ≤ 0.1 %Loss on drying (105 °C; 3 h): ≤ 0.2 %Corresponds to FCC V
• Legal Information: SAFC is a registered trademark of Merck KGaA, Darmstadt, Germany