Sodium dihydrogen phosphate monohydrate 98.0-103.0% (by anhydrous basis) USP, Multi-Compendial, J.T.Baker®

Supplier: Avantor


Management of Change (MOC) category = HR

3802-01EA 148.74 EUR
3802-01 3802-07 3802-05 3802-25 3802-60
Sodium dihydrogen phosphate monohydrate 98.0-103.0% (by anhydrous basis) USP, Multi-Compendial, J.T.Baker®
Sodium dihydrogen phosphate monohydrate

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

Formula: NaH₂PO₄·H₂O
Melting Pt: 100 °C
Density: 2,04 g/cm³
Storage Temperature: Ambient
MDL Number: MFCD00149208
CAS Number: 10049-21-5
EINECS: 231-449-2
REACH: 01-2119489796-13
Merck Index: 13,08734
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Specification Test Results

GMP Manufactured Product 98.0 - 103.0%
Meets U.S.P Requirements Passes Test
Meets B.P. Chemical Specifications ≤8 ppm
CAUTION: For Manufacturing, processing or repackaging ≤0.014%
Bulk Pharmaceutical Chemical Passes Test
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
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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