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Dihydrogenfosforečnan sodný monohydrát 98.0-103.0% (by anhydrous basis) USP, Multi-Compendial, J.T.Baker®

Dodavatel: Avantor
Varování


Management of Change (MOC) category = HR

J.T. Baker®
3802-25EA 0 CZK
3802-25 3802-05 3802-07 3802-08 3802-60 3802-QM 3802-B1 3802-R 3802-01
Dihydrogenfosforečnan sodný monohydrát 98.0-103.0% (by anhydrous basis) USP, Multi-Compendial, J.T.Baker®
Dihydrogenfosforečnan sodný monohydrát

Maximise the stability of your pharmaceutical formulations and get predictable pH control with reliable, proven buffering agents from Avantor™ Performance Materials.

Vzorec: NaH₂PO₄·H₂O
MW: 137,99 g/mol
Bod tání: 100 °C
Hustota: 2,04 g/cm³
Storage Temperature: Ambient
MDL Number: MFCD00149208
CAS číslo: 10049-21-5
EINECS: 231-449-2
Merck Index: 12,08806
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Objednat

Výsledky specifikačního testu

GMP Manufactured Product
Meets U.S.P Requirements
Meets B.P. Chemical Specifications
CAUTION: For Manufacturing, processing or repackaging
Bulk Pharmaceutical Chemical
Appearance (White crystals or granules) Passes Test
USP - Assay (anhydrous basis) 98.0 - 103.0 %
USP - Aluminum, Calcium, and Related Elements Passes Test
USP - Arsenic (As) ≤ 8 ppm
USP - Chloride (Cl) ≤ 0.014 %
USP - Identification A Passes Test
USP - Identification B Passes Test
USP - Insoluble Substances ≤ 0.2 %
USP - pH (1 in 20) 4.1 - 4.5
USP - Sulfate (SO₄) ≤ 0.15 %
USP - Water (H₂O) 10.0 - 15.0 %
EP - Identification A Passes Test
EP - Identification B Passes Test
EP - Identification C Passes Test
EP - Assay (anhydrous basis) 98.0 - 100.5 %
EP - Chloride (Cl) ≤ 200 ppm
EP - Sulfate (SO₄) ≤ 300 ppm
EP - Reducing Substances Passes Test
Endotoxin Concentration (EU/g) ≤ 2.5
EP - Iron (Fe) ≤ 10 ppm
EP - Appearance of Solution Passes Test
EP - pH 4.2 - 4.5
BP - Identification A Passes Test
BP - Identification B Passes Test
BP - Identification C Passes Test
BP - Identification D Passes Test
BP - Acidity 4.2 - 4.5
BP - Clarity and Color of Solution Passes Test
BP - Arsenic (As) ≤ 2 ppm
BP - Iron (Fe) ≤ 10 ppm
BP - Chloride (Cl) ≤ 200 ppm
BP - Sulfate (SO₄) ≤ 300 ppm
BP - Reducing Substances Passes Test
BP - Loss on Drying at 130°C 11.5 - 14.5 %
BP - Assay (dried basis) 98.0 - 100.5 %
JPE - Assay (dried basis) ≥ 98.0 %
JPE - Identification Passes Test
JPE - pH 4.1 - 4.7
JPE - Clarity and Color of Solution Passes Test
JPE - Chloride (Cl) ≤ 0.005 %
JPE - Sulfate (SO4) ≤ 0.019 %
JPE - Heavy Metals ≤ 10 ppm
JPE - Arsenic (As) ≤ 2 ppm
For EP notated requirements, results are derived from testing Sodium
Phosphate, Monobasic Monohydrate, U.S.P. to the EP Chemical
specifications for Sodium Dihydrogen Phosphate Dihydrate.
For JPE notated requirements, results are derived from testing Sodium
Phosphate, Monobasic Monohydrate, U.S.P. to the JPE Chemical
specifications for Sodium Dihydrogen Phosphate Dihydrate.
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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