品名:Citric acid monohydrate cryst., suitable for use as excipient EMPROVE® Essential Ph Eur,BP,JP,USP,E 330,FCC
中文名:柠檬酸(一水,晶体,JXFL1300021国)
内毒素:<0.5 I.U./mg
规格
Assay (alkalimetric, calculated on anhydrous substance)
99.5 - 100.5 %
Identity (IR-spectrum)
passes test
Appearance
white to almost white or colorless crystals
Appearance of solution (200 g/l; water)
clear (≤ 3 NTU) and not more intense in color than reference solution Y₇, BY₇ or GY₇
Sulphate (SO₄)
≤ 50 ppm
Heavy metals (as Pb)
≤ 5 ppm
Al (Aluminium)
≤ 0.2 ppm
As (Arsenic)
≤ 1 ppm
Hg (Mercury)
≤ 1 ppm
Pb (Lead)
≤ 0.5 ppm
Oxalates (as C₂H₂O₄)
≤ 100 ppm
Residual solvents (ICH (Q3C))
excluded by manufacturing process
Readily carbonisable substance
passes test
Sulfated ash (600 °C)
≤ 0.05 %
Water (according to Karl Fischer)
7.5 - 8.8 %
Bacterial endotoxins
< 0.5
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, USP, E 330, FCC Conforms to the purity criteria on food additives according to the current European Commission Regulation.