| GMP Manufactured Product |
| Meets U.S.P. Requirements |
| Identification A Passes Test |
| Identification B Passes Test |
| Alkalinity Passes Test |
| Water (H2O) 10.0 - 13.0 % |
| Tartrate Passes Test |
| Heavy Metals (as Pb) max. 0.001 % |
| Assay (C6H5Na3O7) (calculated on the anhydrous basis) 99.0 - 100.5 % |
| \Meets BP/Ph.Eur. Chemical Specifications |
| Identification A Passes Test |
| Identification B Passes Test |
| Appearance of Solution Passes Test |
| Acidity or Alkalinity Passes Test |
| Readily Carbonizable Substances Passes Test |
| Chloride (Cl) max. 50 ppm |
| Oxalate (C2O4) max. 300 ppm |
| Sulfate (SO4) max. 150 ppm |
| Heavy Metals (as Pb) max. 10 ppm |
| Water (H2O) 11.0 - 13.0 % |
| Assay (C6H5Na3O7) (calculated on the anhydrous basis) 99.0 - 101.0 % |
| Endotoxin Concentration (EU/g) max. 2.5 |
| \Meets JP Chemical Specifications |
| Assay (C6H5Na3O7) (calculated on the anhydrous basis) 99.0 - 101.0 % |
| pH (1 in 20) 7.5 - 8.5 |
| Clarity and Color of Solution Passes Test |
| Chloride (Cl) max. 0.015 % |
| Identification Passes Test |
| Sulfate (SO4) max. 0.048 % |
| Heavy Metals (as Pb) max. 10 ppm |
| Arsenic (As) max. 2 ppm |
| Tartrate Passes Test |
| Oxalate (C2O4) Passes Test |
| Readily Carbonizable Substances Passes Test |
| Loss on Drying at 180 C 10.0 - 13.0 % |
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