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 |
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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