di-Natriumhydrogenphosphat, wasserfrei 98,0-100,5% (Trockenmasse) USP, Multikompendial, J.T.Baker®

Lieferant: Avantor
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Synonyms: Natriumorthophosphat dibasischdi-Natriumorthophosphatsek. Natriumphosphat

Veränderungsmanagement-Kategorie= R

CH05-07EA 0 CHF
CH05-07
di-Natriumhydrogenphosphat, wasserfrei 98,0-100,5% (Trockenmasse) USP, Multikompendial, J.T.Baker®
di-Natriumhydrogenphosphat
Formel: Na₂HPO₄
MW: 141,96 g/mol
MDL Number: MFCD00003496
CAS-Nummer: 7558-79-4

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Spezifikation Testergebnisse

Meets U.S.P Requirements
Meets ChP Chemical Specifications
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 - Arsenic (As) ≤ 2 ppm
JPE - Identification Passes Test
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
ChP - Identification Passes Test
ChP - Alkalinity (pH) 9.0 - 9.4
ChP - Clarity and Color of Solution Passes Test
ChP - Chloride ≤ 0.001 %
ChP - Sulfate ≤ 0.01 %
ChP - Carbonate Passes Test
ChP - Water-insoluble substances ≤ 0.05 %
ChP - Reducing substances Passes Test
ChP - Loss on drying @ 130 C ≤ 1.0 %
ChP - Heavy metals ≤ 0.001 %
ChP - Arsenic ≤ 0.0002 %
ChP - Assay (dried basis) ≥ 99.0 %
ChP - Sodium dihydrogen phosphate ≤ 2.5 %
ChP - Iron (Fe) ≤ 0.002 %
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.

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