货号:100892

品名:Sucrose low in endotoxins suitable for use as excipient EMPROVE® Essential Ph Eur,BP,JP,NF

中文名:蔗糖(低内毒素, JXFL1300025 国)

内毒素:2.0I.U./g

TAMC(总菌):500 CFU/g

TYMC(霉菌/酵母):100 CFU/g

蔗糖 (低内毒素,JXFL1300025国)Sucrose 100892
规格
Identity passes test
Appearance of solution (50 %; water) passes test
Colour number ≤ 45
Acidity or alkalinity passes test
Spec. rotation (α 20/D; 26 %; water) +66.3 - +67.0 °
Electrical conductivity ≤ 35 µS/cm
Sulfite (as SO₂) ≤ 10 ppm
As (Arsenic) ≤ 0.0001 %
Pb (Lead) ≤ 0.00005 %
Dextrins passes test
Reducing sugars passes test
Residual solvents (ICH Q3C) excluded by production process
Loss on Drying (105°C) ≤ 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, JP, NF