蔗糖（低内毒素，JXFL1300025国）Sucrose 100892

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

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

蔗糖 （低内毒素，JXFL1300025国）Sucrose 100892