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Sodio cloruro 99.0-100.5%, granular, GenAR® USP for haemodialysis, Macron Fine Chemicals™

Fornitore: Avantor Performance Materials
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7713-75EA 0 EUR
7713-75 MACR7713-B3 7713-F9 7713-06 7713-25 MACR7713-B4 7713-04 7713-88 7713-20 7713-29 7713-60 7713-73 7713-45 MACR7713-30 7713-70
Sodio cloruro 99.0-100.5%, granular, GenAR® USP for haemodialysis, Macron Fine Chemicals™
Sodio cloruro
Formula: NaCl
Peso molecolare: 58,44 g/mol
Punto di ebollizione: 1413 °C (1013 hPa)
Punto di fusione: 801 °C
Densità: 2,16 g/cm³ (20 °C)
Temperatura di stoccaggio: Ambiente
MDL Number: MFCD00003477
CAS Number: 7647-14-5
EINECS: 231-598-3
Merck Index: 14,08599

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Risultati del test di specificazione

Meets J.P. Chemical Specifications
Meets F.C.C. Requirements
GMP Manufactured Product
Meets B.P. Chemical Specifications
Meets U.S.P Requirements
Meets E.P. Chemical Specifications
Food GMP Manufactured Product
CAUTION: For Manufacturing, processing or repackaging
Bulk Pharmaceutical Chemical
Bulk Food Chemical
USP - Assay (NaCl)(USP) (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 - Bromide (Br) ≤100 ppm
USP - Loss on Drying at 105°C ≤0.5 %
USP - Iodide (I) Passes Test
USP - Aluminum (Al) ≤0.2 ppm
USP - Magnesium and Alkaline Earth Metals (as Ca) ≤100 ppm
USP - Arsenic (As) ≤1 ppm
USP - Barium (Ba) Passes Test
USP - Ferrocyanide Passes Test
USP - Sulfate (SO₄) ≤200 ppm
USP - Iron (Fe) ≤2 ppm
USP - Nitrite (NO₂) (Absorbance Value) ≤0.01
USP - Phosphate (PO₄) ≤25 ppm
USP - Potassium (K) ≤500 ppm
EP/BP - Assay (NaCl) (dried basis) 99.0 - 100.5 %
EP/BP - Appearance of Solution Passes Test
EP/BP - Acidity or Alkalinity Passes Test
EP/BP - Bromide (Br) ≤100 ppm
EP/BP - Ferrocyanide Passes Test
EP/BP - Identification A Passes Test
EP/BP - Identification B Passes Test
EP/BP - Iodide (I) Passes Test
EP/BP - Nitrite (NO₂) ≤0.01
EP/BP - Phosphate (PO₄) ≤25 ppm
EP/BP - Sulfate (SO₄) ≤200 ppm
EP/BP - Aluminum (Al) ≤0.2 ppm
EP/BP - Arsenic (As) ≤1 ppm
EP/BP - Barium (Ba) Passes Test
EP/BP - Iron (Fe) ≤2 ppm
EP/BP - Magnesium and Alkaline Earth Metals (as Ca) ≤100 ppm
EP/BP - Potassium (K) ≤500 ppm
EP/BP - Loss on Drying at 105°C ≤0.5 %
EP/BP - Endotoxin Concentration, <5 IU/g Passes Test
Endotoxin Concentration (EU/g) ≤2.5
JP - Assay 99.0 - 100.5 %
JP - Identification A Passes Test
JP - Identification B Passes Test
JP - Acidity or Alkalinity Passes Test
JP - Clarity and Color of Solution Passes Test
JP - Bromide (Br) Passes Test
JP - Iodide (I) Passes Test
JP - Ferrocyanide Passes Test
JP - Iron (Fe) Passes Test
JP - Heavy Metals (as Pb) ≤3 ppm
JP - Barium (Ba) Passes Test
JP - Magnesium and Alkaline Earth Metals Passes Test
JP - Phosphate (PO₄) Passes Test
JP - Sulfates (as SO₄) Passes Test
JP - Arsenic (As) ≤2 ppm
JP - Loss on Drying at 105°C ≤0.5 %
FCC - Assay (as NaCl) (FCC) (ignited basis) 99.0 - 100.5 %
FCC - Arsenic (As) ≤1 ppm
FCC - Calcium and Magnesium (FCC) ≤0.35 %
FCC - Heavy Metals (as Pb)(FCC) ≤2 mg/kg
FCC - Identification A Passes Test
FCC - Identification B Passes Test
FCC - 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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