JT Baker® 3248-01 Potassium Phosphate, Monobasic, Crystal, NF Grade, Multi-Compendial Grade, 500g Glass Bottle (Case of 4)
Item Number:JTB-3248-01
Manufacturer Part No:JT-3248-01
Manufacturer:Avantor
Units:Case of 4 x 500g Glass Bottles
Details
- Case of 4 x 500g Glass Bottles
Product Specifications
| TEST | SPECIFICATION |
| GMP Manufactured Product | |
| Meets B.P. Chemical Specifications | |
| Meets E.P. Chemical Specifications | |
| Meets N.F. Requirements | |
| 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 - Heavy Metals (as Pb) | <= 0.002 % |
| 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 - Arsenic (As) | <= 2 ppm |
| EP/BP - Chloride (Cl) | <= 200 ppm |
| EP/BP - Heavy Metals (as Pb) | <= 10 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 |
| 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. | |
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Product Specifications
| TEST | SPECIFICATION |
| GMP Manufactured Product | |
| Meets B.P. Chemical Specifications | |
| Meets E.P. Chemical Specifications | |
| Meets N.F. Requirements | |
| 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 - Heavy Metals (as Pb) | <= 0.002 % |
| 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 - Arsenic (As) | <= 2 ppm |
| EP/BP - Chloride (Cl) | <= 200 ppm |
| EP/BP - Heavy Metals (as Pb) | <= 10 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 |
| 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. | |