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Sodium dihydrogen phosphate monohydrate, EMPROVE® EXPERT BP, USP suitable for use as excipient, SAFC®
 :  MilliporeSigma
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Sodium dihydrogen phosphate monohydrate, EMPROVE® EXPERT BP, USP suitable for use as excipient, SAFC®
 :  MilliporeSigma
 

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  • pH Value:
    4.1 - 4.5 (50 g/l, H2O, 25 °C)
  • Bulk Density:
    880 kg/m3
  • Solubility:
    850 g/l
  • LD 50 oral:
    LD50 Rat > 2000 mg/kg
  • LD 50 dermal:
    LD50 Rabbit > 7940 mg/kg
  • Storage:
    Store at 15 to 25 °C
  • Assay (Alkalimetric, calculated on dried substance):
    98.0 - 100.5%
  • Identity:
    Passes Test
  • Appearance of Solution:
    Passes Test
  • Insoluble Substances:
    ≤0.2%
  • pH-value (5%; water):
    4.2 - 4.5
  • Chloride (Cl):
    ≤ 0.014%
  • Sulphate (SO4):
    ≤0.03%
  • Heavy metals (as Pb):
    ≤0.001%
  • Al (Aluminium):
    ≤0.0002%
  • As (Arsenic):
    ≤0.0002%
  • Fe (Iron):
    ≤0.001%
  • Aluminium, Calcium and related elements:
    Passes Test
  • Reducing substances:
    Passes Test
  • Residual solvents (ICH Q3C):
    excluded by manufacturing process
  • Loss on drying (130 °C):
    11.5 - 14.5%
  • Water:
    10.0 - 15.0%
  • Endotoxins:
    ≤2.5 I.U./g