Sucrose, EMPROVE® ESSENTIAL Ph. Eur., BP, JP, NF, ChP suitable for use as excipient low in endotoxins, SAFC®
Supplier: MERCK PRODUCTION CHEMICALS
M-Clarity™ quality level = MQ500 (more info.)
1.00892.9050
1.00892.5000
1.00892.9029
1.00892.9050EA
0
GBP
1.00892.9050
1.00892.5000
1.00892.9029
Sucrose, EMPROVE® ESSENTIAL Ph. Eur., BP, JP, NF, ChP suitable for use as excipient low in endotoxins, SAFC®
D(+)-Sucrose
Formula:
C₁₂H₂₂O₁₁ Melting Pt: 185,5 °C Density: 1,59 g/cm³ (25 °C) Storage Temperature: Ambient |
MDL Number:
MFCD00006626 CAS Number: 57-50-1 EINECS: 200-334-9 Merck Index: 13,08966 |
Specification Test Results
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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