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 dihydrateEthylenediaminetetra-acetic acid disodium salt dihydrateEdetate disodium dihydrateEthylenediaminetetraacetic acid, disodium salt, dihydrateEthylenediaminetetraacetic acid disodium salt dihydrateKestranal® 2S 2 H2OEthylenedinitrilotetra-acetic acid disodium salt dihydrateTitriplex IIIKestranal® 2S dihydrateEdetic acid disodium salt dihydrateDisodium dihydrogen ethylenediaminetetraacetate dihydrateSequestrene Na₂

Management of Change (MOC) category = R

7727-06 MACR7727-04 MACR7727-06 7727-88 MACR7727-88 7727-04
CAMK772706EA 969.68 CAD
MK772704 MK772788 CAMK772706 CAMK772704 MK772706 CAMK772788
EDTA disodium salt dihydrate 99.0-101.0% (dried basis), GenAR® USP for biotechnology, Macron Fine Chemicals™
EDTA disodium salt dihydrate
Formula: C₁₀H₁₄N₂Na₂O₈·2H₂O
MW: 372.24 g/mol
Melting Pt: 255 °C
MDL Number: MFCD00150037
CAS Number: 6381-92-6
Merck Index: 13,03543
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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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