Avantor社(アバンター)のグローバルスタンダードに 対応する試薬・溶媒

塩化ナトリウム/Sodium chloride 99.0-100.5% (dried basis)（JT3627-1 塩化ナトリウム）の特徴

試験結果

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