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octan sodu trihydrat 99.0-101.0% (dry basis), kryształy USP, Multi-Compendial, J.T.Baker®

Dostawca: Avantor
Uwaga

Synonim: Acetic acid, sodium salt, trihydratePlasmafusin

Management of Change (MOC) category = R

CH06-07EA 0 PLN
CH06-QM CH06-07
octan sodu trihydrat 99.0-101.0% (dry basis), kryształy USP, Multi-Compendial, J.T.Baker®
octan sodu trihydrat
Formuła: H₃CCOONa·3H₂O
MW: 136,08 g/mol
Temp. Zapłonu: 250,0 °C
Numer MDL: MFCD00071557
Numer CAS: 6131-90-4

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Wyniki testów specyfikacyjnych

GMP Manufactured Product
Meets ChP Chemical Specifications
Meets J.P. Chemical Specifications
Meets B.P. Chemical Specifications
Meets E.P. Chemical Specifications
Meets U.S.P Requirements
CAUTION: For Manufacturing, processing or repackaging
Bulk Pharmaceutical Chemical
USP - Assay (CH₃COONa) (dried basis) 99.0 - 101.0 %
USP - Calcium and Magnesium Passes Test
USP - Chloride (Cl) ≤ 0.035 %
USP - Endotoxin Concentration (EU/g) ≤ 2.5
USP - Identification Passes Test
USP - Insoluble Matter ≤ 0.05 %
USP - Loss on Drying 38.0 - 41.0 %
USP - pH of 5% Solution at 25°C 7.5 - 9.2
USP - Potassium (K) Passes Test
USP - Sulfate (SO₄) ≤ 0.005 %
EP/BP - Assay (CH₃COONa) 99.0 - 101.0 %
EP/BP - Identification A Passes Test
EP/BP - Identification B Passes Test
EP/BP - Identification C Passes Test
EP/BP - Appearance of Solution Passes Test
EP/BP - pH (1 in 20) 7.5 - 9.0
EP/BP - Reducing Substances Passes Test
EP/BP - Chloride (Cl) ≤ 200 ppm
EP/BP - Sulfate (SO₄) ≤ 200 ppm
EP/BP - Calcium and Magnesium ≤ 50 ppm
EP/BP - Iron (Fe) ≤ 10 ppm
EP/BP - Loss on Drying 39.0 - 40.5 %
JP - Assay (CH₃COONa) 99.5 - 101.0 %
JP - Identification Passes Test
JP - Clarity and Color of Solution Passes Test
JP - Acidity or Alkalinity Passes Test
JP - Chloride (Cl) ≤ 0.011 %
JP - Sulfate (SO₄) ≤ 0.017 %
JP - Heavy Metals (as Pb) ≤ 10 ppm
JP - Calcium and Magnesium Passes Test
JP - Arsenic (As) ≤ 2 ppm
JP - Substances Reducing Permanganate Passes Test
JP - Loss on Drying 39.0 - 40.5 %
FCC - Alkalinity ≤ 0.05 %
FCC - Assay (CH₃COONa) (dried basis) 99.0 - 101.0 %
FCC - Identification A Passes Test
FCC - Identification B Passes Test
FCC - Lead (Pb) ≤ 2 mg/kg
FCC - Loss on Drying 38.0 - 41.0 %
FCC - Potassium Compounds Passes Test
ChP - Assay (dried basis) ≥ 99.0 %
ChP - Identification Passes Test
ChP - Alkalinity (pH) 7.5 - 9.2
ChP - Chloride ≤ 0.035 %
ChP - Sulfate ≤ 0.005 %
ChP - Loss on Drying 38.0 - 41.0 %
ChP - Insoluble matter ≤ 0.05 %
ChP - Calcium and Magnesium Passes Test
ChP - Potassium Passes Test
ChP - Iron (Fe) ≤ 0.001 %
ChP - Heavy metals ≤ 0.001
ChP - Arsenic ≤ 0.0003 %
ChP - Endotoxin Concentration, EU/g ≤ 2.5
No Class 1, 2, 3 or other solvent is likely to be present in the final
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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