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

リン酸ナトリウム 二塩基性 7水和物/Disodium hydrogen phosphate heptahydrate 98.0-100.5% (dried basis)（3803-01 リン酸ナトリウム 二塩基性 7水和物）の特徴

試験結果

GMP Manufactured Product
Meets U.S.P Requirements
CAUTION: For Manufacturing, processing or repackaging
Bulk Pharmaceutical Chemical
Appearance (Colorless or translucent crystals or granules) Passes Test
USP - Assay (Na₂HPO₄) (dried basis) 98.0 - 100.5 %
USP - Arsenic (As) ≤ 16 ppm
USP - Chloride (Cl) ≤ 0.06 %
USP - Endotoxin Concentration (EU/g) ≤ 2.5
USP - Identification Passes Test
USP - Insoluble Substances ≤ 0.4 %
USP - Loss on Drying 43.0 - 50.0 %
USP - Sulfate (SO₄) ≤ 0.2 %
EP - Identification A Passes Test
EP - Identification C Passes Test
EP - Identification D Passes Test
EP - Reducing Substances Passes Test
EP - Monosodium Phosphate ≤ 2.5 %
EP - Chloride (Cl) ≤ 200 ppm
EP - Sulfate (SO₄) ≤ 500 ppm
EP - Appearance of Solution Passes Test
EP - Iron (Fe) ≤ 20 ppm
EP - Assay (dried basis) 98.0 - 101.0 %
JP - Arsenic (As) ≤ 2 ppm
JP - Assay (Na₂HPO₄) (dried basis) 98.0 - 101.0 %
JP - Carbonate (CO₃) Passes Test
JP - Chloride (Cl) ≤ 0.014 %
JP - Clarity and Color of Solution Passes Test
JP - Heavy Metals ≤ 10 ppm
JP - Identification Passes Test
JP - pH (1 in 50) 9.0 - 9.4
JP - Sulfate (SO₄) ≤ 0.038 %
No Class 1,2,3 or other solvents are used or produced in the
manufacturing or purification of the product.
The EP results are derived from testing Sodium Phosphate, Dibasic,
7-Hydrate, U.S.P. to the EP chemical specifications derived from
Disodium Phosphate Dihydrate and Disodium Phosphate Dodecahydrate.
The JP results are derived from testing Sodium Phosphate, Dibasic,
7-Hydrate, U.S.P. to the JP chemical specifications derived from Dibasic
Sodium Phosphate Hydrate.
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.