Sodium chlorure 99,0-100,5 Dried, granular USP, multi-compendial, J.T.Baker®
Marques : AvantorTotal Evaluation: 0
Moyenne des Notes : 0.0 sur 5
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Attention
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Synonyme(s):
Chlorure de sodium
- Management of Change (MOC) category = R
- GMP manufactured product
Formule:
NaCl Poids moléculaire: 58.44 g/mol Point d'ébullition: 1413 °C (1013 hPa) Point de fusion: 801 °C Densité: 2.16 g/cm³ Température de stockage: Température ambiante |
Numéro MDL:
MFCD00003477 Numéro CAS: 7647-14-5 EINECS: 231-598-3 Indice Merck: 14,08599 |
Résultats des tests de spécification
Meets J.P. Chemical Specifications | Passes Test |
Meets U.S.P Requirements | Passes Test |
Meets B.P. Chemical Specifications | Passes Test |
Meets E.P. Chemical Specifications | Passes Test |
GMP Manufactured Product | ≤0.2 ppm |
CAUTION: For Manufacturing, processing or repackaging | ≤1 ppm |
Bulk Pharmaceutical Chemical | Passes Test |
USP - Identification A | Passes Test |
USP - Identification B | Passes Test |
USP - Acidity or Alkalinity | Passes Test |
USP - Appearance of Solution | Passes Test |
USP - Aluminum (Al) | ≤0.2 ppm |
USP - Arsenic (As) | ≤1 ppm |
USP - Barium (Ba) | Passes Test |
USP - Bromide (Br) | ≤100 ppm |
USP - Ferrocyanide | Passes Test |
USP - Iodides (I) | Passes Test |
USP - Iron (Fe) | ≤2 ppm |
USP - Loss on Drying at 105°C | ≤0.5 % |
USP - Magnesium and Alkaline Earth Metals (as Ca) | ≤100 ppm |
USP - Nitrite (NO₂) (Absorbance Value) | ≤0.01 |
USP - Phosphate (PO₄) | ≤25 ppm |
USP - Potassium (K) | ≤500 ppm |
USP - Sulfate (SO₄) | ≤200 ppm |
USP - Assay (NaCl) (dried basis) | 99.0 - 100.5 % |
EP/BP - Identification A | Passes Test |
EP/BP - Identification B | Passes Test |
EP/BP - Aluminum (Al) | ≤0.2 ppm |
EP/BP - Appearance of Solution | Passes Test |
EP/BP - Acidity or Alkalinity | Passes Test |
EP/BP - Bromide (Br) | ≤100 ppm |
EP/BP - Ferrocyanide | Passes Test |
EP/BP - Iodide (I) | Passes Test |
EP/BP - Nitrite (NO₂) | ≤0.01 |
EP/BP - Phosphate (PO₄) | ≤25 ppm |
EP/BP - Sulfate (SO₄) | ≤200 ppm |
EP/BP - Arsenic (As) | ≤1 ppm |
EP/BP - Barium (Ba) | Passes Test |
EP/BP - Iron (Fe) | ≤2 ppm |
EP/BP - Magnesium and Alkaline Earth Metals | ≤100 ppm |
EP/BP - Loss on Drying at 105°C | ≤0.5 % |
EP/BP - Potassium (K) | ≤500 ppm |
EP/BP - Assay (NaCl) (dried basis) | 99.0 - 100.5 % |
EP/BP - Endotoxin Concentration, IU/g | ≤2.5 |
JP - Assay (NaCl) (dried basis) | 99.0 - 100.5 % |
JP - Identification A | Passes Test |
JP - Identification B | Passes Test |
JP - Acidity or Alkalinity | Passes Test |
JP - Clarity and Color of Solution | Passes Test |
JP - Bromide (Br) | Passes Test |
JP - Ferrocyanide | Passes Test |
JP - Iodide (I) | Passes Test |
JP - Iron (Fe) | Passes Test |
JP - Magnesium and Alkaline Earth Metals | Passes Test |
JP - Phosphate (PO₄) | Passes Test |
JP - Sulfates (SO₄) | Passes Test |
JP - Heavy Metals (as Pb) | ≤3 ppm |
JP - Barium (Ba) | Passes Test |
JP - Arsenic (As) | ≤2 ppm |
JP - Loss on Drying | ≤0.5 % |
Total Aerobic Microbial Count, For Information Only | |
Total Yeasts and Molds Count, For Information Only | |
No Class 1,2,3 or other solvents are used or produced in the | |
manufacturing or purification of the product. | |
Must be subjected to further processing during the preparation of | |
injectable dosage forms | |
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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