Avantor社(アバンター)のグローバルスタンダードに 対応する試薬・溶媒

クエン酸ナトリウム 2水和物/tri-Sodium citrate dihydrate 99.0-105.0% (by anhydrous basis)（JT3647-1 クエン酸ナトリウム 2水和物）の特徴

試験結果

GMP Manufactured Product
Meets E.P. Chemical Specifications
Meets B.P. Chemical Specifications
Meets U.S.P Requirements
Meets J.P. Chemical Specifications
CAUTION: For Manufacturing, processing or repackaging
Bulk Pharmaceutical Chemical
USP - Identification A Passes Test
USP - Identification B Passes Test
USP - Identification C Passes Test
USP - Alkalinity Passes Test
USP - Water (H₂O) 10.0 - 13.0 %
USP - Tartrate Passes Test
USP - Assay (C₆H₅Na₃O₇) (calculated on the anhydrous basis) 99.0 - 100.5 %
EP/BP - Identification A Passes Test
EP/BP - Identification B Passes Test
EP/BP - Appearance of Solution Passes Test
EP/BP - Acidity or Alkalinity Passes Test
EP/BP - Readily Carbonizable Substances Passes Test
EP/BP - Chloride (Cl) ≤50 ppm
EP/BP - Oxalate (C₂O₄) ≤300 ppm
EP/BP - Sulfate (SO₄) ≤150 ppm
EP/BP - Water (H₂O) 11.0 - 13.0 %
EP/BP - Assay (C₆H₅Na₃O₇) (calculated on the anhydrous basis) 99.0 - 101.0 %
EP/BP - Endotoxin Concentration (EU/g) ≤2.5
JP - Assay (C₆H₅Na₃O₇) (calculated on the anhydrous basis) 99.0 - 101.0 %
JP - pH (1 in 20) 7.5 - 8.5
JP - Clarity and Color of Solution Passes Test
JP - Chloride (Cl) ≤0.015 %
JP - Identification Passes Test
JP - Sulfate (SO₄) ≤0.048 %
JP - Heavy Metals (as Pb) ≤10 ppm
JP - Arsenic (As) ≤2 ppm
JP - Tartrate Passes Test
JP - Oxalate (C₂O₄) Passes Test
JP - Readily Carbonizable Substances Passes Test
JP - Loss on Drying at 180°C 10.0 - 13.0 %
Total Aerobic Microbial Count, For Information Only
Total Yeasts and Molds Count, For Information Only
E. coli Negative
P. aureginosa Negative
No Class 1,2,3 or other solvents are used or produced in the
manufacturing or purification of the product.
Elemental Impurities (USP 232, EP 5.20) - Information on elemental
impurities for this product is available on the associated Product
Regulatory Data Sheet and elemental impurity profile report.