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 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 (perchloric acid titration, calculated on dried substance)98.5 - 101.0 %Identity (IR-spectrum)passes testIdentity (specific rotation)passes testAppearancewhite to almost white, crystalline powder or shiny flakesAppearance of solution (50 g/l; hydrochloric acid 1 mol/l)clear and not more intense in color than reference solution BY₆Spec. rotation (α 20/D, 40 g/l, hydrochloric acid 250 g/l, calc. on dried substance)+14.5 to +16.5Spec. rotation (α 25/D, 40 g/l, hydrochloric acid 6 mol/l, calc. on dried substance)+14.9 to +17.3pH (10 g/l, CO₂-free water)5.5 - 7.0Chloride (Cl)≤ 200 ppmSulfate (SO₄)≤ 300 ppmFe (Iron)≤ 10 ppmFe (Iron) (ICP)≤ 10 ppmRelated Compounds, total (TLC)≤ 0.5 %Related compounds (HPLC) (Isoleucine)≤ 0.8 %Related compounds (HPLC) (any unspecified impurity)≤ 0.2 %Related compounds (HPLC) (total unspecified impurities)≤ 1.0 %Ninhydrin-positive substances (LC)(impurity A (570 nm))≤ 0.8 %Ninhydrin-positive substances (LC)(any ninhydrin-positive impurity)≤ 0.2 %Ninhydrin-positive substances (LC) (ammonium (570 nm))≤ 0.02 %Ninhydrin-positive substances (LC)(total impurities)≤ 1.0 %Residual solvents (ICH Q3C)excluded by manufacturing processSulfated ash (600 °C)≤ 0.1 %Loss on drying (105 °C; 3 h)≤ 0.2 %Bacterial endotoxins≤ 3.0 I.U./gTotal aerobic microbial count (TAMC)≤ 100 CFU/gTotal combined yeasts/moulds count (TYMC)≤ 100 CFU/gElemental 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., USP
• Legal Information: Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany