Résultats des tests de spécification
Meets B.P. Chemical Specifications |
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Meets E.P. Chemical Specifications |
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GMP Manufactured Product |
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Meets J.P. Chemical Specifications |
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Meets U.S.P Requirements |
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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 |
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manufacturing or purification of the product. |
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Must be subjected to further processing during the preparation of |
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injectable dosage forms. |
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Elemental Impurities (USP 232, EP 5.20) - Information on elemental |
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impurities for this product is available on the associated Product |
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Regulatory Data Sheet and elemental impurity profile report. |
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