JT Baker® 3804-65 Sodium Phosphate Dibasic Anhydrous, USP Grade, Multi-Compendial Grade, 50Kg Flowmor Container
- 50Kg Flowmor Drum
- Manufacturer Part No: JT-3804-65
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Details
Product Specifications
| TEST | SPECIFICATION |
| Meets JPE Specifications | |
| Meets E.P. Chemical Specifications | |
| Meets U.S.P Requirements | |
| GMP Manufactured Product | |
| CAUTION: For Manufacturing, processing or repackaging | |
| Bulk Pharmaceutical Chemical | |
| USP - Assay (Na₂HPO₄) (dried basis) | 98.0 - 100.5 % |
| USP - Identification | Passes Test |
| USP - Loss on Drying at 130°C | <= 5.0 % |
| USP - Insoluble Substances | <= 0.4 % |
| USP - Chloride (Cl) | <= 0.06 % |
| USP - Sulfate (SO₄) | <= 0.2 % |
| USP - Arsenic (As) | <= 16 ppm |
| USP - Heavy Metals (as Pb) | <= 0.002 % |
| USP - Endotoxin Concentration (2.5 EU/g max.) | Passes Test |
| JPE - Assay (dried basis) | >= 99.0 % |
| JPE - Arsenic (As) | <= 2 ppm |
| JPE - Carbonate | Passes Test |
| JPE - Chloride (Cl) | <= 0.011 % |
| JPE - Clarity and Color of Solution | Passes Test |
| JPE - Heavy Metals | <= 10 ppm |
| JPE - pH (1-100) | 9.0 - 9.4 |
| JPE - Sulfate (SO₄) | <= 0.038 % |
| JPE - Loss on Drying | <= 2.0 % |
| EP - Assay (Na₂HPO₄) (dried basis) | 98.0 - 101.0 % |
| EP - Appearance of Solution | Passes Test |
| EP - Identification A | Passes Test |
| EP - Identification B | Passes Test |
| EP - Identification C | Passes Test |
| EP - Identification D | Passes Test |
| EP - Reducing Substances | Passes Test |
| EP - Arsenic (As) | <= 2 ppm |
| EP - Chloride (Cl) | <= 200 ppm |
| EP - Heavy Metals (as Pb) | <= 10 ppm |
| EP - Iron (Fe) | <= 20 ppm |
| EP - Loss on Drying | <= 1.0 % |
| EP - Monosodium Phosphate | <= 2.5 % |
| EP - Sulfate (SO₄) | <= 500 ppm |
| No Class 1,2,3 or other solvents are used or produced in the | |
| manufacturing or purification of the product. | |
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Product Specifications
| TEST | SPECIFICATION |
| Meets JPE Specifications | |
| Meets E.P. Chemical Specifications | |
| Meets U.S.P Requirements | |
| GMP Manufactured Product | |
| CAUTION: For Manufacturing, processing or repackaging | |
| Bulk Pharmaceutical Chemical | |
| USP - Assay (Na₂HPO₄) (dried basis) | 98.0 - 100.5 % |
| USP - Identification | Passes Test |
| USP - Loss on Drying at 130°C | <= 5.0 % |
| USP - Insoluble Substances | <= 0.4 % |
| USP - Chloride (Cl) | <= 0.06 % |
| USP - Sulfate (SO₄) | <= 0.2 % |
| USP - Arsenic (As) | <= 16 ppm |
| USP - Heavy Metals (as Pb) | <= 0.002 % |
| USP - Endotoxin Concentration (2.5 EU/g max.) | Passes Test |
| JPE - Assay (dried basis) | >= 99.0 % |
| JPE - Arsenic (As) | <= 2 ppm |
| JPE - Carbonate | Passes Test |
| JPE - Chloride (Cl) | <= 0.011 % |
| JPE - Clarity and Color of Solution | Passes Test |
| JPE - Heavy Metals | <= 10 ppm |
| JPE - pH (1-100) | 9.0 - 9.4 |
| JPE - Sulfate (SO₄) | <= 0.038 % |
| JPE - Loss on Drying | <= 2.0 % |
| EP - Assay (Na₂HPO₄) (dried basis) | 98.0 - 101.0 % |
| EP - Appearance of Solution | Passes Test |
| EP - Identification A | Passes Test |
| EP - Identification B | Passes Test |
| EP - Identification C | Passes Test |
| EP - Identification D | Passes Test |
| EP - Reducing Substances | Passes Test |
| EP - Arsenic (As) | <= 2 ppm |
| EP - Chloride (Cl) | <= 200 ppm |
| EP - Heavy Metals (as Pb) | <= 10 ppm |
| EP - Iron (Fe) | <= 20 ppm |
| EP - Loss on Drying | <= 1.0 % |
| EP - Monosodium Phosphate | <= 2.5 % |
| EP - Sulfate (SO₄) | <= 500 ppm |
| No Class 1,2,3 or other solvents are used or produced in the | |
| manufacturing or purification of the product. | |