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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Synonyms:
Monopotassiumphosphate, prim.-Potassium phosphate, Monopotassium phosphate, Potassium phosphate monobasic, Monobasic Potassium Phosphate, Potassium dihydrogen orthophosphate
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.
Certifications: Meets NF requirements and EP and BP chemical specifications.
Caution: 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].
Formula:
KH₂PO₄ MW: 136,09 g/mol Boiling Pt: ∼100 °C (1013 hPa) Melting Pt: 253 °C Density: 2,3 g/cm³ (20 °C) Storage Temperature: Ambient |
MDL Number:
MFCD00011401 CAS Number: 7778-77-0 EINECS: 231-913-4 REACH: 01-2119490224-41 Merck Index: 13,07744 |
Specification Test Results
Meets N.F. Requirements | |
Meets E.P. Chemical Specifications | |
Meets B.P. Chemical Specifications | |
GMP Manufactured Product | |
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. | |
Metallic Residues: No metal catalysts or metal reagents, as defined by | |
EMA Guideline EMEA/CHMP/SWP/4446/2000 , are used in the production of | |
this material. | |
This product has been filled to +/- 1% of the stated net weight. |
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