Sucrose, EMPROVE® ESSENTIAL Ph. Eur., BP, JP, NF, ChP adatto a essere utilizzato come eccipiente basso valore di endotossine, SAFC®
Fornitore: MERCK PRODUCTION CHEMICALS
Synonyms:
β-ᴅ-Fructofuranosyl-α-ᴅ-glucopyranoside, α-ᴅ-Glucopyranosyl β-ᴅ-fructofuranoside, D(+)-Saccharose, α-ᴅ-Glc-(1→2)-β-ᴅ-Fru, Sucrose
M-Clarity™ quality level = MQ500
1.00892.9050
1.00892.5000
1.00892.9029
1.00892.9050EA
0
EUR
1.00892.9050
1.00892.5000
1.00892.9029
Sucrose, EMPROVE® ESSENTIAL Ph. Eur., BP, JP, NF, ChP adatto a essere utilizzato come eccipiente basso valore di endotossine, SAFC®
D(+)-Saccarosio
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Formula:
C₁₂H₂₂O₁₁ Peso molecolare: 342,3 g/mol Punto di fusione: 185,5 °C Densità: 1,59 g/cm³ (25 °C) Temperatura di stoccaggio: Ambiente |
MDL Number:
MFCD00006626 CAS Number: 57-50-1 EINECS: 200-334-9 Merck Index: 13,08966 |
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Risultati del test di specificazione
| 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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