JT Baker® 3803-R Sodium Phosphate Dibasic 7-Hydrate, USP Grade, 200Lb Poly Drum
- 200Lb Poly Drum
- Manufacturer Part No: JT-3803-R
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Details
Product Specifications
| TEST | SPECIFICATION |
| Meets U.S.P Requirements | |
| GMP Manufactured Product | |
| CAUTION: For Manufacturing, processing or repackaging | |
| Bulk Pharmaceutical Chemical | |
| Appearance (Colorless or translucent crystals or granules) | Passes Test |
| USP - Assay (Na₂HPO₄) (dried basis) | 98.0 - 100.5 % |
| USP - Arsenic (As) | <= 16 ppm |
| USP - Chloride (Cl) | <= 0.06 % |
| USP - Endotoxin Concentration (EU/g) | <= 2.5 |
| USP - Heavy Metals (as Pb) | <= 0.002 % |
| USP - Identification | Passes Test |
| USP - Insoluble Substances | <= 0.4 % |
| USP - Loss on Drying | 43.0 - 50.0 % |
| USP - Sulfate (SO₄) | <= 0.2 % |
| EP - Identification A | Passes Test |
| EP - Identification C | Passes Test |
| EP - Identification D | Passes Test |
| EP - Reducing Substances | Passes Test |
| EP - Monosodium Phosphate | <= 2.5 % |
| EP - Arsenic (As) | <= 2 ppm |
| EP - Chloride (Cl) | <= 200 ppm |
| EP - Sulfate (SO₄) | <= 500 ppm |
| EP - Heavy Metals (as Pb) | <= 10 ppm |
| EP - Appearance of Solution | Passes Test |
| EP - Iron (Fe) | <= 20 ppm |
| EP - Assay (anhydrous basis) | 98.0 - 101.0 % |
| JP - Arsenic (As) | <= 2 ppm |
| JP - Assay (Na₂HPO₄) (dried basis) | 98.0 - 101.0 % |
| JP - Carbonate (CO₃) | Passes Test |
| JP - Chloride (Cl) | <= 0.014 % |
| JP - Clarity and Color of Solution | Passes Test |
| JP - Heavy Metals | <= 10 ppm |
| JP - Identification | Passes Test |
| JP - pH (1 in 50) | 9.0 - 9.4 |
| JP - Sulfate (SO₄) | <= 0.038 % |
| No Class 1,2,3 or other solvents are used or produced in the | |
| manufacturing or purification of the product. | |
| The EP results are derived from testing Sodium Phosphate, Dibasic, | |
| 7-Hydrate, U.S.P. to the EP chemical specifications derived from | |
| Disodium Phosphate Dihydrate and Disodium Phosphate Dodecahydrate. | |
| The JP results are derived from testing Sodium Phosphate, Dibasic, | |
| 7-Hydrate, U.S.P. to the JP chemical specifications derived from Dibasic | |
| Sodium Phosphate Hydrate. | |
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Product Specifications
| TEST | SPECIFICATION |
| Meets U.S.P Requirements | |
| GMP Manufactured Product | |
| CAUTION: For Manufacturing, processing or repackaging | |
| Bulk Pharmaceutical Chemical | |
| Appearance (Colorless or translucent crystals or granules) | Passes Test |
| USP - Assay (Na₂HPO₄) (dried basis) | 98.0 - 100.5 % |
| USP - Arsenic (As) | <= 16 ppm |
| USP - Chloride (Cl) | <= 0.06 % |
| USP - Endotoxin Concentration (EU/g) | <= 2.5 |
| USP - Heavy Metals (as Pb) | <= 0.002 % |
| USP - Identification | Passes Test |
| USP - Insoluble Substances | <= 0.4 % |
| USP - Loss on Drying | 43.0 - 50.0 % |
| USP - Sulfate (SO₄) | <= 0.2 % |
| EP - Identification A | Passes Test |
| EP - Identification C | Passes Test |
| EP - Identification D | Passes Test |
| EP - Reducing Substances | Passes Test |
| EP - Monosodium Phosphate | <= 2.5 % |
| EP - Arsenic (As) | <= 2 ppm |
| EP - Chloride (Cl) | <= 200 ppm |
| EP - Sulfate (SO₄) | <= 500 ppm |
| EP - Heavy Metals (as Pb) | <= 10 ppm |
| EP - Appearance of Solution | Passes Test |
| EP - Iron (Fe) | <= 20 ppm |
| EP - Assay (anhydrous basis) | 98.0 - 101.0 % |
| JP - Arsenic (As) | <= 2 ppm |
| JP - Assay (Na₂HPO₄) (dried basis) | 98.0 - 101.0 % |
| JP - Carbonate (CO₃) | Passes Test |
| JP - Chloride (Cl) | <= 0.014 % |
| JP - Clarity and Color of Solution | Passes Test |
| JP - Heavy Metals | <= 10 ppm |
| JP - Identification | Passes Test |
| JP - pH (1 in 50) | 9.0 - 9.4 |
| JP - Sulfate (SO₄) | <= 0.038 % |
| No Class 1,2,3 or other solvents are used or produced in the | |
| manufacturing or purification of the product. | |
| The EP results are derived from testing Sodium Phosphate, Dibasic, | |
| 7-Hydrate, U.S.P. to the EP chemical specifications derived from | |
| Disodium Phosphate Dihydrate and Disodium Phosphate Dodecahydrate. | |
| The JP results are derived from testing Sodium Phosphate, Dibasic, | |
| 7-Hydrate, U.S.P. to the JP chemical specifications derived from Dibasic | |
| Sodium Phosphate Hydrate. | |