GMP Manufactured Product |
Meets U.S.P. & F.C.C. Requirements |
Assay (NaCl)(USP) (dried basis) 99.0 - 100.5 % |
Assay (as NaCl) (FCC) (ignited basis) 99.0 - 100.5 % |
Identification A Passes Test |
Identification B Passes Test |
Solubility (10 in 50) Passes Test |
Loss on Drying at 105 C max. 0.5 % |
Acidity or Alkalinity Passes Test |
Iodide (I) Passes Test |
Barium (Ba) Passes Test |
Magnesium and Alkaline Earth Metals (as Ca) max. 100 ppm |
Calcium and Magnesium max. 0.35 % |
Arsenic (As) max. 1 ppm |
Nitrite (NO2) max. 0.01 |
Heavy Metals (as Pb) max. 2 ppm |
Sulfate (SO4) max. 0.020 % |
Phosphate (PO4) max. 25 ppm |
Iron (Fe) max. 2 ppm |
Bromide (Br) max. 0.010 % |
Appearance of Solution Passes Test |
Ferrocyanide Passes Test |
Aluminum (Al) max. 0.2 ppm |
Potassium (K) max. 0.05 % |
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Product Information (not specifications): |
Appearance (white, crystalline granules, slightly hygroscopic) |
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Preserve in well-closed containers. |
Must be subjected to further processing during the preparation of injectable dosage forms. |