Description

• General description: Our SAFC® portfolio of high-quality products for biopharmaceutical processing withstands strict quality control procedures and is produced according to MQ-500 requirements as defined by the M-Clarity program.M-Clarity ProgramAs part of our EMPROVE® Program, our raw materials are offered with EMPROVE® Dossiers which provide comprehensive, up-to-date documentation to help you navigate regulatory challenges, manage risks, and improve your manufacturing processes.Our comprehensive portfolio of downstream 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. Ranging from non-GMP grades for low-risk application, to IPEC-PQG GMP for higher-risk applications, we have products covering all your manufacturing needs.
• Analysis Note: Assay (iodometric, calc. on dried substance): 98.0 - 101.0 %Identity (IR-spectrum): passes testAppearance: white to almost white, slightly agglomerated, crystalline powderAppearance of solution (100 g/l, water): clear and colorless.Spec. rotation (α 20/D, 40 g/l, water, calc. on dried substance): -15.5° to -17.5°Chloride (Cl): ≤ 200 ppmSulfate (SO₄): ≤ 300 ppmAs (Arsenic): ≤ 1.5 ppmFe (Iron): ≤ 10 ppmFe (Iron) (ICP): ≤ 10 ppmNH₄ (Ammonium): ≤ 200 ppmCu (Copper)*: ≤ 25 ppmRelated substances (CE) (Impurity A (Cysteinylglycine)): ≤ 0.5 %Related substances (CE) (Impurity B (Cysteine)): ≤ 0.5 %Related substances (CE) (Impurity C (Glutathione oxidized)): ≤ 1.5 %Related substances (CE) (Impurity D (Glutamylcysteine)): ≤ 1.0 %Related substances (CE) (Impurity E): ≤ 0.5 %Related substances (CE) (Largest unspecified impurity): ≤ 0.2 %Related substances (CE) (Sum of all impurities): ≤ 2.5 %Acetic acid (HS-GC): ≤ 5000 ppmEthanol (HS-GC): ≤ 5000 ppmEthyl acetate (HS-GC): ≤ 5000 ppmOther residual solvents (ICH Q3C): passes testSulfated ash (600 °C): ≤ 0.1 %Loss on drying (105 °C; 3 h): ≤ 0.5 %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.
• Legal Information: Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany