Sodium chloride 99.0-100.5% (dried basis), powder, GenAR® USP, Macron Fine Chemicals™
Supplier: AVANTOR PERFORMANCE MATERIAL LLC
|
Warning
|
Synonyms:
Halite
, Sea salt
, NaCl
, Saline
Management of Change (MOC) category = R
7540-40
7540-88
7540-26
MACR7540-04
MACR7540-88
MACR7540-40
MACR7540-06
MACR7540-26
MACR7540-16
7540-16
7540-06
7540-04
CAJT7540-40CS
1789.78
CAD
JT7540-40
CAJT7540-40
CAMK754088
MK754088
MK754006
CAJT7540-16
MK754004
MK754026
CAMK754006
JT7540-16
CAMK754026
CAMK754004
Sodium chloride 99.0-100.5% (dried basis), powder, GenAR® USP, Macron Fine Chemicals™
Sodium chloride
|
Formula:
NaCl MW: 58.44 g/mol Boiling Pt: 1413 °C (1013 hPa) Melting Pt: 801 °C Density: 2.16 g/cm³ (20 °C) |
MDL Number:
MFCD00003477 CAS Number: 7647-14-5 Merck Index: 14,08599 |
Specification Test Results
| Meets B.P. Chemical Specifications | |
| Meets E.P. Chemical Specifications | |
| GMP Manufactured Product | |
| Meets J.P. Chemical Specifications | |
| Meets U.S.P Requirements | |
| CAUTION: For Manufacturing, processing or repackaging | |
| Bulk Pharmaceutical Chemical | |
| USP - Assay (NaCl) (dried basis) | 99.0 - 100.5 % |
| USP - Appearance of Solution | Passes Test |
| USP - Identification A | Passes Test |
| USP - Identification B | Passes Test |
| USP - Acidity or Alkalinity | Passes Test |
| USP - Iodide (I) | Passes Test |
| USP - Bromide (Br) | ≤100 ppm |
| USP - Loss on Drying at 105°C | ≤0.5 % |
| USP - Aluminum (Al)(µg/g) | ≤0.2 |
| USP - Barium (Ba) | Passes Test |
| USP - Magnesium and Alkaline Earth Metals (as Ca) | ≤100 ppm |
| USP - Arsenic (As) | ≤1 ppm |
| USP - Ferrocyanide | Passes Test |
| USP - Iron (Fe) | ≤2 ppm |
| USP - Potassium (K) | ≤500 ppm |
| USP - Sulfate (SO₄) | ≤200 ppm |
| USP - Nitrite (NO₂) (Absorbance Value) | ≤0.01 |
| USP - Phosphate (PO₄) | ≤25 ppm |
| Solubility (5 in 50) | Passes Test |
| 100% Passing through a US 20 Mesh Sieve | Passes Test |
| On U.S. No. 80 Sieve | 30 - 50 % |
| EP/BP - Assay (NaCl) (dried basis) | 99.0 - 100.5 % |
| EP/BP - Acidity or Alkalinity | Passes Test |
| EP/BP - Aluminum (Al) | ≤0.2 ppm |
| EP/BP - Bromide (Br) | ≤100 ppm |
| EP/BP - Barium (Ba) | Passes Test |
| EP/BP - Iodide (I) | Passes Test |
| EP/BP - Identification A | Passes Test |
| EP/BP - Identification B | Passes Test |
| EP/BP - Loss on Drying at 100-105°C | ≤0.5 % |
| EP/BP - Sulfate (SO₄) | ≤200 ppm |
| EP/BP - Appearance of Solution | Passes Test |
| EP/BP - Magnesium and Alkaline Earth Metals (as Ca) | ≤100 ppm |
| EP/BP - Arsenic (As) | ≤1 ppm |
| EP/BP - Endotoxin Concentration, <5 IU/g | Passes Test |
| EP/BP - Iron (Fe) | ≤2 ppm |
| EP/BP - Ferrocyanide | Passes Test |
| EP/BP - Nitrite (NO₂) | ≤0.01 |
| EP/BP - Potassium (K) | ≤500 ppm |
| EP/BP- Limit of Phosphate | ≤25 ppm |
| JP - Assay (NaCl) (dried basis) | 99.0 - 100.5 % |
| JP - Acidity or Alkalinity | Passes Test |
| JP - Arsenic (As) | ≤2 ppm |
| JP - Barium (Ba) | Passes Test |
| JP - Bromide (Br) | Passes Test |
| JP - Ferrocyanide | Passes Test |
| JP - Iron (Fe) | Passes Test |
| JP - Iodide (I) | Passes Test |
| JP - Magnesium and Alkaline Earth Metals | Passes Test |
| JP - Phosphate (PO₄) | Passes Test |
| JP - Sulfates (as SO₄) | Passes Test |
| JP - Clarity and Color | Passes Test |
| JP - Heavy Metals (as Pb) | ≤3 ppm |
| JP - Identification A | Passes Test |
| JP - Identification B | Passes Test |
| JP - Loss on Drying at 105°C | ≤0.5 % |
| 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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