Sodium chloride 99.0-100.5% (dried basis), powder, GenAR® USP, Macron Fine Chemicals™

Supplier: Avantor Performance Materials
Warning

Synonyms: Saline, NaCl, Sea salt, Halite

MACR7540-04EA 52.2 SGD
MACR7540-04 MACR7540-26 MACR7540-88 MACR7540-06 MACR7540-16
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)
Storage Temperature: Ambient
MDL Number: MFCD00003477
CAS Number: 7647-14-5
EINECS: 231-598-3
Merck Index: 14,08599

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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 99.0 - 100.5 %
Bulk Pharmaceutical Chemical Passes Test
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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