D(+)-GLUCOSE ANHYDROUS SUITABLE FOR THE BIOPHARMACEUTICAL PRODUCTION EMPROVE(R) BIO PH EUR BP USP ACS (C15-1244-950)

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 Program

As 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 test
Identity (spec. rotation calc. on anhydrous substance): passes test
Identity (HPLC): passes test
Identity (water): passes test
Appearance of solution: passes test
Color and clarity of solution: passes test
Titrable acid: ≤ 0.002 meq/g
Conductivity: ≤ 20 µS/cm
Spec. 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 ppm
Fe (Iron): ≤ 5 ppm
Related 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 test
Soluble starch, sulfite: ≤ 15 ppm
Starch: passes test
Residual solvents (ICH Q3C): excluded by the manufacturing process
Loss 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/g
Microbiological purity(Total yeast and mould count (TYMC)): ≤ 100 CFU/g
Bile tolerant Gram negative Bacteria(absent in 1 g): passes test
Escherichia coli (absent in 1 g): passes test
Pseudomonas aeruginosa (absent in 1 g): passes test
Staphylococcus aureus (absent in 1 g): passes test
Candida albicans (absent in 1 g): passes test
Salmonella ssp (absent in 10 g): passes test
Endotoxins: ≤ 10 I.U./g
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,BP,USP,ACS

Legal Information

Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany

SAFC is a registered trademark of Merck KGaA, Darmstadt, Germany