Sodium Chloride, Granular USP - GenAR, Intended for Hemodialysis Use, Macron™
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Sodium Chloride, Granular USP - GenAR, Intended for Hemodialysis Use, Macron™
Formula: NaCl
Formula Weight: 58.44
Intended for Hemodialysis Use
Meets USP & FCC Requirements
| Assay (NaCl) (USP) (dried basis) |
99.0 – 100.5% |
| Assay (as NaCl) (FCC) (ignited basis) |
99.0 – 100.5% |
| Appearance of Solution |
Passes Test |
| Identification A |
Passes Test |
| Identification B |
Passes Test |
| Acidity or Alkalinity |
Passes Test |
| Loss on Drying at 105°C |
max. 0.5% |
| Iodide (I) |
Passes Test |
| Aluminum (Al) |
max. 0.2 ppm |
| Magnesium and Alkaline Earth Metals (as Ca) |
max. 0.01% |
| Arsenic (As) |
max. 1 ppm |
| Barium (Ba) |
Passes Test |
| Ferrocyanide |
Passes Test |
| Sulfate (SO4) |
max. 0.020% |
| Iron (Fe) |
max. 2 ppm |
| Nitrite (NO2) |
max. 0.01 |
| Heavy Metals (as Pb) (USP) |
max. 5 ppm |
| Limit of Bromide |
max. 0.010% |
| Limit of Phosphate |
max. 0.0025% |
| Limit of Potassium |
max. 0.05% |
| Calcium and Magnesium (FCC) |
max. 0.35% |
| Heavy Metals (as Pb) (FCC) |
max. 2 mg/kg |
Meets BP/Ph.Eur. Chemical Specifications
| Assay (as NaCl) (dried basis) |
99.0 – 100.5% |
| Appearance of Solution |
Passes Test |
| Acidity or Alkalinity |
Passes Test |
| Bromide (Br) |
max. 100 ppm |
| Ferrocyanide |
Passes Test |
| Identification A |
Passes Test |
| Identification B |
Passes Test |
| Iodide (I) |
Passes Test |
| Nitrite (NO2) |
max. 0.01 |
| Phosphate (PO4) |
max. 25 ppm |
| Sulfate (SO4) |
max. 200 ppm |
| Aluminum (Al) |
max. 0.2 ppm |
| Arsenic (As) |
max. 1 ppm |
| Barium (Ba) |
Passes Test |
| Iron (Fe) |
max. 2 ppm |
| Magnesium and Alkaline Earth Metals (as Ca); |
max. 100 ppm |
| Potassium (K) |
max. 500 ppm |
| Heavy Metals |
max. 5 ppm |
| Loss on Drying at 105°C |
max. 0.5% |
| Endotoxin Concentration, < 5 IU/g |
Passes Test |
| Endotoxin Concentration (EU/g) |
max. 2.5 |
Meets JP Chemical Specifications
| Assay |
99.0 – 100.5% |
| Identification A |
Passes Test |
| Identification B |
Passes Test |
| Acidity or Alkalinity |
Passes Test |
| Clarity and Color of Solution |
Passes Test |
| Bromide (Br) |
Passes Test |
| Iodide (I) |
Passes Test |
| Ferrocyanide |
Passes Test |
| Iron (Fe) |
Passes Test |
| Heavy Metals (as Pb) |
max. 3 ppm |
| Barium (Ba) |
Passes Test |
| Magnesium and Alkaline Earth Metals |
Passes Test |
| Phosphate (PO4) |
Passes Test |
| Sulfates (as SO4) |
Passes Test |
| Arsenic (As) |
max. 2 ppm |
| Loss on Drying at 105°C |
max. 0.5% |
No Class 1, 2, 3 or other solvents are used or produced in the manufacturing or purification of the product. Bulk Food Chemical Bulk Pharmaceutical Chemical Preserve in well-closed containers Must be subjected to further processing during the preparation of injectable dosage forms.
| CAS Number |
7647-14-5 |
| HTS Number |
2501000000 |
| Specific Gravity |
1L = 2.16kg |
| Storage Color Code |
Green |
| Management of Change |
R |