Natriumklorid 99.0-100.5%, granular USP, Multi-Compendial, J.T.Baker®
Leverantör: Avantor
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Varning
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3627-S1
3627-01EA
580
SEK
3627-01
3627-05
3627-07
3627-20
3627-08
3627-65
3627-60
3627-68
3627-S1
Natriumklorid 99.0-100.5%, granular USP, Multi-Compendial, J.T.Baker®
Natriumklorid
- Management of Change (MOC) category = R
- GMP manufactured product
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Formel:
NaCl Kokpunkt: 1413 °C (1013 hPa) Smältpunkt: 801 °C Densitet: 2,16 g/cm³ Storage Temperature: Omgivande |
MDL Number:
MFCD00003477 CAS nummer: 7647-14-5 EINECS: 231-598-3 Merck Index: 14,08599 |
Specifikation testresultat
| 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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