EDTA disodium salt dihydrate, GenAR® USP, Macron Fine Chemicals™
Supplier: AVANTOR PERFORMANCE MATERIAL LLC
Synonyms:
Ethylenediaminetetraacetic acid disodium dihydrate
, Ethylenediaminetetra-acetic acid disodium salt dihydrate
, Edetate disodium dihydrate
, Ethylenediaminetetraacetic acid, disodium salt, dihydrate
, Ethylenediaminetetraacetic acid disodium salt dihydrate
, Kestranal® 2S 2 H2O
, Ethylenedinitrilotetra-acetic acid disodium salt dihydrate
, Titriplex III
, Kestranal® 2S dihydrate
, Edetic acid disodium salt dihydrate
, Disodium dihydrogen ethylenediaminetetraacetate dihydrate
, Sequestrene Na₂
Management of Change (MOC) category = R
Formula:
C₁₀H₁₄N₂Na₂O₈·2H₂O MW: 372.24 g/mol 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 E.P. Chemical Specifications | |
GMP Manufactured Product | |
Meets J.P. Chemical Specifications | |
Meets U.S.P Requirements | |
CAUTION: For Manufacturing, processing or repackaging | |
Bulk Pharmaceutical Chemical | |
USP - Assay (Dried Basis) | 99.0 - 101.0 % |
Appearance (white crystals or white powder) | 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 - Limit of Nitrilotriacetic Acid | ≤0.1 % |
EP - Assay | 98.5 - 101.0 % |
EP - Appearance of Solution | Passes Test |
EP - Identification A | Passes Test |
EP - Identification B | Passes Test |
EP - Identification D | Passes Test |
EP - pH.... | 4.0 - 5.5 |
EP - Iron (Fe) | ≤80 ppm |
EP - Impurity A | ≤0.1 % |
JP - Assay | 99.0 - 101.0 % |
JP - Identification A | Passes Test |
JP - Identification B | Passes Test |
JP - Identification C | Passes Test |
JP - pH | 4.3 - 4.7 |
JP - Clarity and Color of Solution | Passes Test |
JP - Cyanide (CN) | Passes Test |
JP - Heavy Metals | ≤10 ppm |
JP - Arsenic (As) | ≤2 ppm |
JP - Residue on 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. | |
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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