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Disodium hydrogen phosphate, anhydrous USP, Multi-Compendial HP, J.T.Baker®

Supplier: AVANTOR PERFORMANCE MATERIALS

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4953-07EA 92559.14 INR InStock
4953-07 4953-01
Disodium hydrogen phosphate, anhydrous USP, Multi-Compendial HP, J.T.Baker®
di-Sodium hydrogen phosphate


Formula: Na₂HPO₄
MW: 141.96 g/mol
Melting Pt: 250 °C
Density: 1.53 g/cm³ (20 °C)
Storage Temperature: Ambient
 MDL Number: MFCD00003496
CAS Number: 7558-79-4
EINECS: 231-448-7
REACH: 01-2119489797-11
Merck Index: 12,08805
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Specification Test Results
Meets JPE Specifications
GMP Manufactured Product
Meets U.S.P Requirements
Meets E.P. Chemical Specifications
CAUTION: For Manufacturing, processing or repackaging
Bulk Pharmaceutical Chemical
USP - Assay (Na₂HPO₄) (dried basis) 98.0 - 100.5 %
USP - Identification Passes Test
USP - Loss on Drying at 130°C ≤ 5.0 %
USP - Insoluble Substances ≤ 0.4 %
USP - Chloride (Cl) ≤ 0.06 %
USP - Sulfate (SO₄) ≤ 0.2 %
USP - Arsenic (As) ≤ 16 ppm
JPE - Assay (dried basis) ≥ 99.0 %
JPE - Arsenic (As) ≤ 2 ppm
JPE - Carbonate Passes Test
JPE - Chloride (Cl) ≤ 0.011 %
JPE - Clarity and Color of Solution Passes Test
JPE - Heavy Metals ≤ 10 ppm
JPE - pH (1-100) 9.0 - 9.4
JPE - Sulfate (SO₄) ≤ 0.038 %
JPE - Loss on Drying ≤ 2.0 %
EP - Assay (Na₂HPO₄) (dried basis) 98.0 - 101.0 %
EP - Appearance of Solution Passes Test
EP - Identification A Passes Test
EP - Identification B Passes Test
EP - Identification C Passes Test
EP - Identification D Passes Test
EP - Reducing Substances Passes Test
EP - Chloride (Cl) ≤ 200 ppm
EP - Iron (Fe) ≤ 20 ppm
EP - Loss on Drying ≤ 1.0 %
EP - Monosodium Phosphate ≤ 2.5 %
EP - Sulfate (SO₄) ≤ 500 ppm
Endotoxin Concentration (EU/g) ≤ 2.5
Microbial Testing – Total Aerobic Microbial Count (USP) ≤ 10 cfu/g
Microbial Testing – Total Yeast and Mold Count (USP) ≤ 10 cfu/g
Microbial Testing - Salmonella (USP) Negative
Microbial Testing - Escherichia coli (USP) Negative
Microbial Testing - Staphylococcus aureus (USP) Negative
Microbial Testing - Pseudomonas aeruginosa (USP) Negative
Microbial Testing -Bile tolerant gram-negative bacteria Negative
Microbial Testing – Clostridia Negative
Microbial Testing - Candida albicans Negative
Trace Impurities - Cadmium (Cd) ≤ 200 ppb
Trace Impurities - Lead (Pb) ≤ 500 ppb
Trace Impurities - Arsenic (As) ≤ 1500 ppb
Trace Impurities - Mercury (Hg) ≤ 300 ppb
Trace Impurities - Cobalt (Co) ≤ 500 ppb
Trace Impurities - Vanadium (V) ≤ 1000 ppb
Trace Impurities - Nickel (Ni) ≤ 2000 ppb
Trace Impurities - Thallium (Tl) ≤ 800 ppb
Trace Impurities - Gold (Au) ≤ 10000 ppb
Trace Impurities - Palladium (Pd) ≤ 1000 ppb
Trace Impurities - Iridium (Ir) ≤ 1000 ppb
Trace Impurities - Osmium (Os) ≤ 1000 ppb
Trace Impurities - Rhodium (Rh) ≤ 1000 ppb
Trace Impurities - Ruthenium (Ru) ≤ 1000 ppb
Trace Impurities - Selenium (Se) ≤ 8000 ppb
Trace Impurities - Silver (Ag) ≤ 1000 ppb
Trace Impurities - Platinum (Pt) ≤ 1000 ppb
Trace Impurities - Lithium (Li) ≤ 25000 ppb
Trace Impurities - Antimony (Sb) ≤ 9000 ppb
Trace Impurities - Barium (Ba) ≤ 70000 ppb
Trace Impurities - Molybdenum (Mo) ≤ 150000 ppb
Trace Impurities - Copper (Cu) ≤ 30000 ppb
Trace Impurities - Tin (Sn) ≤ 60000 ppb
Trace Impurities - Chromium (Cr) ≤ 110000 ppb
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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