Disodium hydrogen phosphate heptahydrate 98.0-100.5% (dried basis) USP, J.T.Baker®

Supplier: Avantor
Warning

Synonyms: Sodium phosphate dibasic heptahydrate, Sodium hydrogen phosphate heptahydrate, Sodium monohydrogen phosphate heptahydrate

Management of Change (MOC) category = HR

3803-01EA 126 GBP
3803-01 3803-07 3803-R 3803-65
Disodium hydrogen phosphate heptahydrate 98.0-100.5% (dried basis) USP, J.T.Baker®
di-Sodium hydrogen phosphate heptahydrate
Formula: HNa₂O₄P·7H₂O
MW: 268,07 g/mol
Melting Pt: 48 °C
Density: 1,7 g/cm³ (20 °C)
Storage Temperature: Ambient
MDL Number: MFCD00149180
CAS Number: 7782-85-6
EINECS: 231-448-7

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Specification Test Results

GMP Manufactured Product 98.0 - 100.5%
Meets U.S.P Requirements ≤16 ppm
CAUTION: For Manufacturing, processing or repackaging ≤0.06%
Bulk Pharmaceutical Chemical ≤2.5
Appearance (Colorless or translucent crystals or granules) Passes Test
USP - Assay (Na₂HPO₄) (dried basis) 98.0 - 100.5 %
USP - Arsenic (As) ≤ 16 ppm
USP - Chloride (Cl) ≤ 0.06 %
USP - Endotoxin Concentration (EU/g) ≤ 2.5
USP - Identification Passes Test
USP - Insoluble Substances ≤ 0.4 %
USP - Loss on Drying 43.0 - 50.0 %
USP - Sulfate (SO₄) ≤ 0.2 %
EP - Identification A Passes Test
EP - Identification C Passes Test
EP - Identification D Passes Test
EP - Reducing Substances Passes Test
EP - Monosodium Phosphate ≤ 2.5 %
EP - Chloride (Cl) ≤ 200 ppm
EP - Sulfate (SO₄) ≤ 500 ppm
EP - Appearance of Solution Passes Test
EP - Iron (Fe) ≤ 20 ppm
EP - Assay (dried basis) 98.0 - 101.0 %
JP - Arsenic (As) ≤ 2 ppm
JP - Assay (Na₂HPO₄) (dried basis) 98.0 - 101.0 %
JP - Carbonate (CO₃) Passes Test
JP - Chloride (Cl) ≤ 0.014 %
JP - Clarity and Color of Solution Passes Test
JP - Heavy Metals ≤ 10 ppm
JP - Identification Passes Test
JP - pH (1 in 50) 9.0 - 9.4
JP - Sulfate (SO₄) ≤ 0.038 %
No Class 1,2,3 or other solvents are used or produced in the
manufacturing or purification of the product.
The EP results are derived from testing Sodium Phosphate, Dibasic,
7-Hydrate, U.S.P. to the EP chemical specifications derived from
Disodium Phosphate Dihydrate and Disodium Phosphate Dodecahydrate.
The JP results are derived from testing Sodium Phosphate, Dibasic,
7-Hydrate, U.S.P. to the JP chemical specifications derived from Dibasic
Sodium Phosphate Hydrate.
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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