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 (calc. on anhydrous substance): 97.5 - 102.0 %Identity (IR): passes testIdentity (spec. rotation calc. on anhydrous substance): passes testIdentity (HPLC): passes testIdentity (water): passes testAppearance of solution: passes testColor and clarity of solution: passes testTitrable acid: ≤ 0.002 meq/gConductivity: ≤ 20 µS/cmSpec. rotation (α25/D): 52.5 - 53.0 °In water insoluble matter: ≤ 0.005 %Chloride (Cl): ≤ 0.01 %Sulfate (SO₄): ≤ 0.005 %Heavy metals (as Pb): ≤ 5 ppmFe (Iron): ≤ 5 ppmRelated substances [sum of impurities A (maltose) and B (isomaltose)!: ≤ 0.4 %Related substances [Impurity C (maltotriose)!: ≤ 0.2 %Related substances [Impurity D (fructose)!: ≤ 0.15 %Related substances (unspecified impurities): ≤ 0.10 %Related substances (Sum of all impurities): ≤ 0.5 %Dextrin: passes testSoluble starch, sulfite: ≤ 15 ppmStarch: passes testResidual solvents (ICH Q3C): excluded by the manufacturing processLoss on drying (105 °C): ≤ 0.2 %Water (according to Karl Fischer): ≤ 1.0 %Sulfated ash (600 °C): ≤ 0.02 %Microbiological purity(Total aerobic microbial count (TAMC)): ≤ 100 CFU/gMicrobiological purity(Total yeast and mould count (TYMC)): ≤ 100 CFU/gBile tolerant Gram negative Bacteria(absent in 1 g): passes testEscherichia coli (absent in 1 g): passes testPseudomonas aeruginosa (absent in 1 g): passes testStaphylococcus aureus (absent in 1 g): passes testCandida albicans (absent in 1 g): passes testSalmonella ssp (absent in 10 g): passes testEndotoxins: ≤ 10 I.U./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,BP,USP,ACS
• Legal Information: Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany