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D(+)-glukoza, bezwodny, EMPROVE® EXPERT ACS, Ph. Eur., BP, USP, SAFC®

Dostawca: MERCK PRODUCTION CHEMICALS

1.37048.5000 1.37048.9012 1.37048.9029
1.37048.5000EA 0 PLN
1.37048.5000 1.37048.9012 1.37048.9029
D(+)-glukoza, bezwodny, EMPROVE® EXPERT ACS, Ph. Eur., BP, USP, SAFC®
D(+)-glukoza
Formuła: C₆H₁₂O₆
Temp. topnienia: 146 °C
Gęstość: 1,54 g/cm³ (20 °C)
Temperatura przechowywania: Temperatura otoczenia
Numer MDL: MFCD00148912
Numer CAS: 50-99-7
Numer WE (dawny EINECS): 200-075-1
Klasyfikacja Merck : 14,04459
https://digitalassets.avantorsciences.com/adaptivemedia/rendition?id=47ec28c7fd4803097405f8eaef3171b3a40d40c5&vid=62627c96e2ae9f2a0cae732d0ddf0a100247298e&prid=web&clid=SAPDAM

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Wyniki testów specyfikacyjnych

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


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