Natriumacetat Trihydrat 99,0-101,0% (Trockenmasse), Kristalle USP, Multikompendial, J.T.Baker®
Lieferant: Avantor
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Achtung
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Synonyms:
Essigsäure Natriumsalz Trihydrat
Veränderungsmanagement-Kategorie= R
CH06-07EA
0
CHF
CH06-QM
CH06-07
Natriumacetat Trihydrat 99,0-101,0% (Trockenmasse), Kristalle USP, Multikompendial, J.T.Baker®
Natriumacetat Trihydrat
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Formel:
H₃CCOONa·3H₂O MW: 136,08 g/mol Flash-Pt: 250,0 °C |
MDL Number:
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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