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

产品大类:
默克原辅料

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.