JT Baker® 3648-07 Sodium Citrate, Dihydrate, Granular, USP Grade, Multi-Compendial Grade, 12Kg Poly Pail
- 12Kg Poly Pail
- Manufacturer Part No: JT-3648-07
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Details
Product Specifications
TEST | SPECIFICATION |
Meets E.P. Chemical Specifications | |
Meets U.S.P Requirements | |
Meets B.P. Chemical Specifications | |
Meets J.P. Chemical Specifications | |
GMP Manufactured Product | |
CAUTION: For Manufacturing, processing or repackaging | |
Bulk Pharmaceutical Chemical | |
USP - Identification A | Passes Test |
USP - Identification B | Passes Test |
USP - Identification C | Passes Test |
USP - Alkalinity | Passes Test |
USP - Water (H₂O) | 10.0 - 13.0 % |
USP - Tartrate | Passes Test |
USP - Heavy Metals (as Pb) | <= 0.001 % |
USP - Assay (C₆H₅Na₃O₇) (calculated on the anhydrous basis) | 99.0 - 100.5 % |
EP/BP - Identification A | Passes Test |
EP/BP - Identification B | Passes Test |
EP/BP - Appearance of Solution | Passes Test |
EP/BP - Acidity or Alkalinity | Passes Test |
EP/BP - Readily Carbonizable Substances | Passes Test |
EP/BP - Chloride (Cl) | <= 50 ppm |
EP/BP - Oxalate (C₂O₄) | <= 300 ppm |
EP/BP - Sulfate (SO₄) | <= 150 ppm |
EP/BP - Heavy Metals (as Pb) | <= 10 ppm |
EP/BP - Water (H₂O) | 11.0 - 13.0 % |
EP/BP - Assay (C₆H₅Na₃O₇) (calculated on the anhydrous basis) | 99.0 - 101.0 % |
EP/BP - Endotoxin Concentration (EU/g) | <= 2.5 |
JP - Assay (C₆H₅Na₃O₇) (calculated on the anhydrous basis) | 99.0 - 101.0 % |
JP - pH (1 in 20) | 7.5 - 8.5 |
JP - Clarity and Color of Solution | Passes Test |
JP - Chloride (Cl) | <= 0.015 % |
JP - Identification | Passes Test |
JP - Sulfate (SO₄) | <= 0.048 % |
JP - Heavy Metals (as Pb) | <= 10 ppm |
JP - Arsenic (As) | <= 2 ppm |
JP - Tartrate | Passes Test |
JP - Oxalate (C₂O₄) | Passes Test |
JP - Readily Carbonizable Substances | Passes Test |
JP - Loss on Drying at 180°C | 10.0 - 13.0 % |
Calcium (Ca) | <= 0.005 % |
Iron (Fe) | <= 5 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 E.P. Chemical Specifications | |
Meets U.S.P Requirements | |
Meets B.P. Chemical Specifications | |
Meets J.P. Chemical Specifications | |
GMP Manufactured Product | |
CAUTION: For Manufacturing, processing or repackaging | |
Bulk Pharmaceutical Chemical | |
USP - Identification A | Passes Test |
USP - Identification B | Passes Test |
USP - Identification C | Passes Test |
USP - Alkalinity | Passes Test |
USP - Water (H₂O) | 10.0 - 13.0 % |
USP - Tartrate | Passes Test |
USP - Heavy Metals (as Pb) | <= 0.001 % |
USP - Assay (C₆H₅Na₃O₇) (calculated on the anhydrous basis) | 99.0 - 100.5 % |
EP/BP - Identification A | Passes Test |
EP/BP - Identification B | Passes Test |
EP/BP - Appearance of Solution | Passes Test |
EP/BP - Acidity or Alkalinity | Passes Test |
EP/BP - Readily Carbonizable Substances | Passes Test |
EP/BP - Chloride (Cl) | <= 50 ppm |
EP/BP - Oxalate (C₂O₄) | <= 300 ppm |
EP/BP - Sulfate (SO₄) | <= 150 ppm |
EP/BP - Heavy Metals (as Pb) | <= 10 ppm |
EP/BP - Water (H₂O) | 11.0 - 13.0 % |
EP/BP - Assay (C₆H₅Na₃O₇) (calculated on the anhydrous basis) | 99.0 - 101.0 % |
EP/BP - Endotoxin Concentration (EU/g) | <= 2.5 |
JP - Assay (C₆H₅Na₃O₇) (calculated on the anhydrous basis) | 99.0 - 101.0 % |
JP - pH (1 in 20) | 7.5 - 8.5 |
JP - Clarity and Color of Solution | Passes Test |
JP - Chloride (Cl) | <= 0.015 % |
JP - Identification | Passes Test |
JP - Sulfate (SO₄) | <= 0.048 % |
JP - Heavy Metals (as Pb) | <= 10 ppm |
JP - Arsenic (As) | <= 2 ppm |
JP - Tartrate | Passes Test |
JP - Oxalate (C₂O₄) | Passes Test |
JP - Readily Carbonizable Substances | Passes Test |
JP - Loss on Drying at 180°C | 10.0 - 13.0 % |
Calcium (Ca) | <= 0.005 % |
Iron (Fe) | <= 5 ppm |
No Class 1,2,3 or other solvents are used or produced in the manufacturing or purification of the product. |