Sucrose, EMPROVE® ESSENTIAL Ph. Eur., BP, JP, NF, ChP velegnet som hjælpestof lavt indhold af endotoksiner, SAFC®

Leverandør: MERCK PRODUCTION CHEMICALS
Ratings: Ingen bedømmelse

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M-Clarity™ quality level = MQ500

1.00892.9050EA 0 DKK
1.00892.9050 1.00892.9029 1.00892.5000
Sucrose, EMPROVE® ESSENTIAL Ph. Eur., BP, JP, NF, ChP velegnet som hjælpestof lavt indhold af endotoksiner, SAFC®
D(+)-Sucrose
Formel: C₁₂H₂₂O₁₁
Molekylvægt: 342,3 g/mol
Smeltepunkt: 169…170 °C
Massefylde: 1,59 g/cm³ (25 °C)
Opbevaringstemperatur: Stue temperatur
MDL Number: MFCD00006626
CAS-nummer: 57-50-1
EINECS: 200-334-9
Merck Index: 12,09051
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Specifikationer Testresultater

Identity (wet chemistry) passes test
Identity (IR) passes test
Appearance of solution (50 %; water) passes test
Color of solution passes test
Color number ≤ 45
Spec. rotation (α 20/D; 26 %; water) 66.3 - 67.0 °
Spec. rotation (α 20/D; 10 %; water) 66.3 - 67.0 °
Electrical conductivity ≤ 35 µS/cm
Sulfite (as SO₂) ≤ 10 ppm
Sulfate (SO₄) ≤ 0.05 %
Heavy metals (as Pb) ≤ 0.0005 %
Ca (Calcium) ≤ 0.05 %
Dextrins passes test
Reducing sugars passes test
Reducing sugars (ChP) ≤ 0.10 %
Residual solvents (ICH Q3C) excluded by production process
Loss on Drying (105 °C) ≤ 0.1 %
Sulfated ash ≤ 0.1 %
Endotoxins < 2
Microbiological purity (Total aerobic microbial count (TAMC)) ≤ 500 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
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, ChP, JP, NF

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