货号:100242

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

 

柠檬酸(一水,晶体,JXFL1300021 国)Citric acid monohydrate 100242
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.