EDTA disodium salt dihydrate 99.0-101.0% (dried basis), crystals USP, Multi-Compendial, J.T.Baker®
Supplier: Avantor
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8995-01EA
245
GBP
8995-01
8995-07
8995-20
EDTA disodium salt dihydrate 99.0-101.0% (dried basis), crystals USP, Multi-Compendial, J.T.Baker®
EDTA disodium salt dihydrate
GMP Manufactured Product
Meets B.P. Chemical Specifications
Meets E.P. Chemical Specifications
Meets J.P. Chemical Specifications
Meets U.S.P Requirements
Formula:
C₁₀H₁₄N₂Na₂O₈·2H₂O Melting Pt: 255 °C Storage Temperature: Ambient |
MDL Number:
MFCD00150037 CAS Number: 6381-92-6 EINECS: 205-358-3 Merck Index: 13,03543 |
Specification Test Results
Meets J.P. Chemical Specifications | — |
Meets U.S.P Requirements | — |
Meets B.P. Chemical Specifications | — |
Meets E.P. Chemical Specifications | — |
GMP Manufactured Product | — |
CAUTION: For Manufacturing, processing or repackaging | — |
Bulk Pharmaceutical Chemical | Passes Test |
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 - 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 - 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 | 37.0 - 39.0 % |
manufacturing or purification of the product. | |
Elemental Impurities (USP 232, EP 5.20) - Information on elemental | |
impurities for this product is available on the associated Product | |
Regulatory Data Sheet and elemental impurity profile report. |
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