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

リン酸カリウム 二塩基性(無水)/Disodium hydrogen phosphate, anhydrous 98.0-100.5% (dried basis)（JT3804-1 リン酸カリウム 二塩基性(無水)）の特徴

試験結果

Meets JPE Specifications
Meets E.P. Chemical Specifications
Meets U.S.P Requirements
GMP Manufactured Product
CAUTION: For Manufacturing, processing or repackaging
Bulk Pharmaceutical Chemical
USP - Assay (Na₂HPO₄) (dried basis) 98.0 - 100.5 %
USP - Identification Passes Test
USP - Loss on Drying at 130°C ≤ 5.0 %
USP - Insoluble Substances ≤ 0.4 %
USP - Chloride (Cl) ≤ 0.06 %
USP - Sulfate (SO₄) ≤ 0.2 %
USP - Arsenic (As) ≤ 16 ppm
USP - Endotoxin Concentration (2.5 EU/g max.) Passes Test
JPE - Assay (dried basis) ≥ 99.0 %
JPE - Identification Passes Test
JPE - Arsenic (As) ≤ 2 ppm
JPE - Carbonate Passes Test
JPE - Chloride (Cl) ≤ 0.011 %
JPE - Clarity and Color of Solution Passes Test
JPE - Heavy Metals ≤ 10 ppm
JPE - pH (1-100) 9.0 - 9.4
JPE - Sulfate (SO₄) ≤ 0.038 %
JPE - Loss on Drying ≤ 2.0 %
EP - Assay (Na₂HPO₄) (dried basis) 98.0 - 101.0 %
EP - Appearance of Solution Passes Test
EP - Identification A Passes Test
EP - Identification B Passes Test
EP - Identification C Passes Test
EP - Identification D Passes Test
EP - Reducing Substances Passes Test
EP - Chloride (Cl) ≤ 200 ppm
EP - Iron (Fe) ≤ 20 ppm
EP - Loss on Drying ≤ 1.0 %
EP - Monosodium Phosphate ≤ 2.5 %
EP - Sulfate (SO₄) ≤ 500 ppm
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.