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CAUTION: For Manufacturing, processing or repackaging
Passes Test
Bulk Pharmaceutical Chemical
= 0.008 %
NF - Identification
Passes Test
NF - Residue on Ignition
≤ 0.008 %
NF - Bromide or Iodide
Passes Test
NF - Free Bromine or Chlorine
Passes Test
NF - Sulfate (SO₄)
Passes Test
NF - Sulfite (SO₃)
Passes Test
NF - Assay (HCl)
36.5 - 38.0 %
EP/BP - Identification A
Passes Test
EP/BP - Identification B
Passes Test
EP/BP - Identification C
Passes Test
EP/BP - Appearance of Solution
Passes Test
EP/BP - Free Chlorine (as Cl₂)
≤ 4 ppm
EP/BP - Sulfate (SO₄)
≤ 20 ppm
EP/BP - Residue on Evaporation
≤ 0.01 %
EP/BP - Assay (HCl)
35.0 - 39.0 %
JP - Assay (HCl)
35.0 - 38.0 %
JP - Identification
Passes Test
JP - Residue on ignition, mg/10mL
≤ 1.0
JP - Bromide or Iodide
Passes Test
JP - Bromine or Chlorine
Passes Test
JP - Sulfate (SO₄)
Passes Test
JP - Sulfite (SO₃)
Passes Test
No Class 1, 2, 3 or other solvents are used or produced in the manufacturing or purification of the product.
= 1 ppm
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.