Natriumacetat Trihydrat 99,0-101,0% (Trockenmasse), Kristalle USP, Multikompendial, J.T.Baker®
Lieferant: Avantor
Achtung
|
Synonyme:
Essigsäure Natriumsalz Trihydrat
Veränderungsmanagement-Kategorie= R
CH06-07EA
0
EUR
CH06-QM
CH06-07
Natriumacetat Trihydrat 99,0-101,0% (Trockenmasse), Kristalle USP, Multikompendial, J.T.Baker®
Natriumacetat Trihydrat
Formel:
H₃CCOONa·3H₂O Molecular Weight: 136,08 g/mol Flammpunkt: 250,0 °C |
MDL:
MFCD00071557 CAS-Nummer: 6131-90-4 |
Spezifikation Testergebnisse
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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