JT Baker® 8995-01 Edetate Disodium, USP Grade, Multi-Compendial Grade, 500g Glass Bottle (Case of 4)
- Case of 4 x 500g Glass Bottles
- Manufacturer Part No: JT-8995-01
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Details
Product Specifications
TEST | SPECIFICATION |
GMP Manufactured Product | |
Meets B.P. Chemical Specifications | |
Meets E.P. Chemical Specifications | |
Meets J.P. Chemical Specifications | |
Meets U.S.P Requirements | |
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 - pH (1 in 20) | 4.0 - 6.0 |
USP - Loss on Drying | 8.7 - 11.4 % |
USP - Calcium (Ca) | Passes Test |
USP - Heavy Metals (as Pb) | <= 0.005 % |
USP - Nitrilotriacetic Acid | <= 0.1 % |
USP - Assay (C₁₀H₁₄N₂Na₂O₈) (dried basis) | 99.0 - 101.0 % |
Endotoxin Concentration (EU/g) | <= 5 |
EP/BP - Assay | 98.5 - 101.0 % |
EP/BP - Identification A | Passes Test |
EP/BP - Identification B | Passes Test |
EP/BP - Identification D | Passes Test |
EP/BP - Impurity A | <= 0.1 % |
EP/BP - Appearance of Solution | Passes Test |
EP/BP - pH (1 in 20) | 4.0 - 5.5 |
EP/BP - Heavy Metals (as Pb) | <= 20 ppm |
EP/BP - Iron (Fe) | <= 80 ppm |
JP - Assay | 99.0 - 101.0 % |
JP - Identification A | Passes Test |
JP - Identification B | Passes Test |
JP - Identification C | Passes Test |
JP - pH of 1% Solution at 25°C | 4.3 - 4.7 |
JP - Clarity and Color of Solution | Passes Test |
JP - Cyanide (CN) | Passes Test |
JP - Heavy Metals (as Pb) | <= 10 ppm |
JP - Arsenic (As) | <= 2 ppm |
JP - Residue after Ignition | 37.0 - 39.0 % |
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 |
GMP Manufactured Product | |
Meets B.P. Chemical Specifications | |
Meets E.P. Chemical Specifications | |
Meets J.P. Chemical Specifications | |
Meets U.S.P Requirements | |
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 - pH (1 in 20) | 4.0 - 6.0 |
USP - Loss on Drying | 8.7 - 11.4 % |
USP - Calcium (Ca) | Passes Test |
USP - Heavy Metals (as Pb) | <= 0.005 % |
USP - Nitrilotriacetic Acid | <= 0.1 % |
USP - Assay (C₁₀H₁₄N₂Na₂O₈) (dried basis) | 99.0 - 101.0 % |
Endotoxin Concentration (EU/g) | <= 5 |
EP/BP - Assay | 98.5 - 101.0 % |
EP/BP - Identification A | Passes Test |
EP/BP - Identification B | Passes Test |
EP/BP - Identification D | Passes Test |
EP/BP - Impurity A | <= 0.1 % |
EP/BP - Appearance of Solution | Passes Test |
EP/BP - pH (1 in 20) | 4.0 - 5.5 |
EP/BP - Heavy Metals (as Pb) | <= 20 ppm |
EP/BP - Iron (Fe) | <= 80 ppm |
JP - Assay | 99.0 - 101.0 % |
JP - Identification A | Passes Test |
JP - Identification B | Passes Test |
JP - Identification C | Passes Test |
JP - pH of 1% Solution at 25°C | 4.3 - 4.7 |
JP - Clarity and Color of Solution | Passes Test |
JP - Cyanide (CN) | Passes Test |
JP - Heavy Metals (as Pb) | <= 10 ppm |
JP - Arsenic (As) | <= 2 ppm |
JP - Residue after Ignition | 37.0 - 39.0 % |
No Class 1,2,3 or other solvents are used or produced in the manufacturing or purification of the product. |