EDTA disodium salt dihydrate 99.0-101.0% (dried basis), GenAR® USP for biotechnology, 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 |
MDL Number:
MFCD00150037 CAS Number: 6381-92-6 Merck Index: 13,03543 |
Specification Test Results
GMP Manufactured Product | |
Meets B.P. Chemical Specifications | |
Meets E.P. Chemical Specifications | |
Food GMP Manufactured Product | |
Meets U.S.P Requirements | |
Meets F.C.C. Requirements | |
CAUTION: For Manufacturing, processing or repackaging | |
Bulk Pharmaceutical Chemical | |
Bulk Food Chemical | |
USP - Assay (dried basis) | 99.0 - 101.0 % |
USP - Identification A | Passes Test |
USP - Identification B | Passes Test |
USP - Identification C | Passes Test |
USP - pH (1 in 20) | 4.0 - 5.5 |
USP - Loss on Drying (by wt) | 8.7 - 11.4 % |
USP - Calcium (Ca) | Passes Test |
USP - Limit of Nitrilotriacetic Acid (by wt) | ≤0.1 % |
EP/BP - Appearance of Solution | Passes Test |
EP/BP - Identification A | Passes Test |
EP/BP - Assay | 98.5 - 101.0 % |
EP/BP - Identification B | Passes Test |
EP/BP - Identification D | Passes Test |
EP/BP - Impurity A and Related Substances - Impurity A | ≤0.1 % |
EP/BP - Iron (Fe) | ≤80 ppm |
EP/BP - pH (1 in 20) | 4.0 - 5.5 |
Endotoxin Concentration (EU/g) | ≤5 |
FCC - Assay (anhydrous basis) | 99.0 - 101.0 % |
FCC - Identification A | Passes Test |
FCC - Identification B | Passes Test |
FCC - Identification C | Passes Test |
FCC - Lead (Pb) | ≤10 mg/kg |
FCC - pH (1 in 100) | 4.3 - 4.7 |
FCC - Calcium (Ca) | Passes Test |
FCC - Limit of Nitrilotriacetic Acid (by wt) | ≤0.1 % |
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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