Potassium dihydrogen phosphate 98.0-100.5% (dried basis), crystals NF, Multi-Compendial, J.T.Baker®
Supplier: Avantor
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Warning
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Management of Change (MOC) category = R
Maximise the stability of your pharmaceutical formulations and get predictable pH control with reliable, proven buffering agents from Avantor™ Performance Materials.
- GMP manufactured product
No Class 1,2,3 or other solvents are used or produced in the manufacturing or purification of the product.
Certifikace: Meets NF requirements and EP and BP chemical specifications.
Upozornení: Store at 20° to 25°C (68° to 77°F), excursion permitted to 15° to 30°C (59° to 86°F) [see USP controlled Room Temperature].
Specification Test Results
Meets N.F. Requirements | |
Meets E.P. Chemical Specifications | |
Meets B.P. Chemical Specifications | |
GMP Manufactured Product | |
Preserve in Tight Containers | |
Preserve in well-closed containers. | |
CAUTION: For Manufacturing, processing or repackaging | |
Bulk Pharmaceutical Chemical | |
NF - Assay (KH₂PO₄) (dried basis) | 98.0 - 100.5 % |
NF - Arsenic (As) | ≤ 3 ppm |
NF - Endotoxin Concentration (2.5 EU/g max.) | Passes Test |
NF - Fluoride (F) | ≤ 0.001 % |
NF - Identification | Passes Test |
NF - Insoluble Substances | ≤ 0.2 % |
NF - Lead (Pb) | ≤ 2 ppm |
NF - Loss on Drying at 105°C | ≤ 1.0 % |
EP/BP - Assay (KH₂PO₄) (dried basis) | 98.0 - 100.5 % |
EP/BP - Appearance of Solution | Passes Test |
EP/BP - Chloride (Cl) | ≤ 200 ppm |
EP/BP - Identification A | Passes Test |
EP/BP - Identification B | Passes Test |
EP/BP - Identification C | Passes Test |
EP/BP - Iron (Fe) | ≤ 10 ppm |
EP/BP - Loss on Drying at 125 - 130°C | ≤ 2.0 % |
EP/BP - Reducing Substances | Passes Test |
EP/BP - pH | 4.2 - 4.5 |
EP/BP - Sulfate (SO₄) | ≤ 300 ppm |
EP/BP - Arsenic (As) | ≤ 2 ppm |
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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