Sodium Chloride, Powder USP - GenAR, Macron™
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Sodium Chloride, Powder USP - GenAR, Macron™
|
Formula: NaCl
Formula Weight: 58.44
TEST |
SPECIFICATION |
| GMP Manufactured Product |
| Meets U.S.P. Requirements |
| Assay (NaCl) (dried basis) |
99.0 - 100.5% |
| Appearance of Solution |
Passes Test |
| Identification A |
Passes Test |
| Identification B |
Passes Test |
| Acidity or Alkalinity |
Passes Test |
| Iodide (I) |
Passes Test |
| Limit of Bromide |
max. 0.010% |
| Loss on Drying at 105°C |
max. 0.5% |
| Aluminum (Al)(μg/g) |
max. 0.2 |
| Barium (Ba) |
Passes Test |
Magnesium and Alkaline Earth Metals
(as Ca) |
max. 0.01% |
| Arsenic (As) |
max. 1 ppm |
| Heavy Metals (as Pb) |
max. 5 ppm |
| Ferrocyanide |
Passes Test |
| Iron (Fe) |
max. 2 ppm |
| Potassium (K) |
max. 500 ppm |
| Sulfate (USP)(SO4) |
max. 0.020% |
| Nitrite (NO2) |
max. 0.01 |
| Limit of Phosphate |
max. 25 ppm |
| Solubility (5 in 50) |
Passes Test |
| Mesh: |
| Thru U.S. No. 20 Sieve |
min. 100% |
| On U.S. No. 80 Sieve |
30 - 50% |
| |
| Meets BP/Ph.Eur. Chemical Specifications |
| Assay (NaCl) (dried basis) |
99.0 - 100.5% |
| Acidity or Alkalinity |
Passes Test |
| Aluminum (Al) |
max. 0.2 ppm |
| Bromide (Br) |
max. 100 ppm |
| Barium (Ba) |
Passes Test |
| Iodide (I) |
Passes Test |
| Identification A |
Passes Test |
| Identification B |
Passes Test |
| Loss on Drying at 100-105°C |
max. 0.5% |
| Sulfate (SO4) |
max. 200 ppm |
| Appearance of Solution |
Passes Test |
Magnesium and Alkaline Earth Metals
(as Ca) |
max. 100 ppm |
| Arsenic (As) |
max. 1 ppm |
| Endotoxin Concentration, <5 IU/g |
Passes Test |
| Heavy Metals (as Pb) |
max. 5 ppm |
| Iron (Fe) |
max. 2 ppm |
| Ferrocyanide |
Passes Test |
| Nitrite (NO2) |
max. 0.01 |
| Potassium (K) |
max. 500 ppm |
| Limit of Phosphate |
max. 25 ppm |
| |
| Meets JP Chemical Specifications |
| Assay (NaCl) (dried basis) |
99.0 - 100.5% |
| Acidity or Alkalinity |
Passes Test |
| Arsenic (As) |
max. 2 ppm |
| Barium (Ba) |
Passes Test |
| Bromide (Br) |
Passes Test |
| Ferrocyanide |
Passes Test |
| Iron (Fe) |
Passes Test |
| Iodide (I) |
Passes Test |
| Magnesium and Alkaline Earth Metals |
Passes Test |
| Phosphate (PO4) |
Passes Test |
| Sulfates (as SO4) |
Passes Test |
| Clarity and Color |
Passes Test |
| Heavy Metals (as Pb) |
max. 3 ppm |
| Identification A |
Passes Test |
| Identification B |
Passes Test |
| Loss on Drying at 105°C |
max. 0.5% |
| |
| Product Information (not specifications): |
| Appearance (white, crystalline powder) |
| No Class 1,2,3 or other solvents are used or produced in the manufacturing or purification of the product. |
| Bulk Pharmaceutical Chemical |
| CAUTION: For manufacturing, processing or repacking. |
| For a Certificate of Lot Analysis, visit www.avantormaterials.com. |
| 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 = 2.16 Kg |
| Storage Color Code |
Green |
| Management of Change |
R |
|