Sodio cloruro 99.0-100.5% (base secada), granular USP, FCC, J.T.Baker®
Proveedor: Avantor
|
Atención
|
Management of Change (MOC) category = HR
3301-37EA
231.41
EUR
3301-37
3301-39
3301-32
3301-35
Sodio cloruro 99.0-100.5% (base secada), granular USP, FCC, J.T.Baker®
Sodio cloruro
Must be subjected to further processing during the preparation of injectable dosage forms.
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Formula:
NaCl Pto. de fusión: 801 °C Densidad: 2,16 g/ml (25 °C) |
Número MDL:
MFCD00003477 Núm. CAS: 7647-14-5 |
Resultados test especificaciones
| GMP Manufactured Product | |
| CAUTION: For Manufacturing, processing or repackaging | |
| 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 % |
| FCC - Assay (as NaCl) (FCC) (ignited basis) | 99.0 - 100.5 % |
| FCC - Identification A | Passes Test |
| FCC - Identification B | Passes Test |
| FCC - Arsenic (As) | ≤ 1 ppm |
| FCC - Calcium and Magnesium | ≤ 0.35 % |
| FCC - Heavy Metals (as Pb) | ≤ 2 ppm |
| FCC - Loss on Drying at 105°C | ≤ 0.5 % |
| Solution Test | Passes Test |
| No Class 1,2,3 or other solvents are used or produced in the | ≤1 ppm |
| manufacturing or purification of the product. | ≤0.35% |
| Must be subjected to further processing during the preparation of | ≤2 ppm |
| injectable dosage forms | ≤0.5% |
| Elemental Impurities (USP 232, EP 5.20) - Information on elemental | Passes Test |
| impurities for this product is available on the associated Product | |
| Regulatory Data Sheet and elemental impurity profile report. |
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