Sodium chloride 99.0-100.5% (dried basis), granular USP, FCC, J.T.Baker®
Supplier: Avantor
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Warning
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Management of Change (MOC) category = HR
3301-37EA
213
GBP
3301-37
3301-39
3301-32
3301-35
Sodium chloride 99.0-100.5% (dried basis), granular USP, FCC, J.T.Baker®
Sodium chloride
Must be subjected to further processing during the preparation of injectable dosage forms.
Formula:
NaCl Melting Pt: 801 °C Density: 2.16 g/ml (25 °C) |
MDL Number:
MFCD00003477 CAS Number: 7647-14-5 |
Specification Test Results
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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