Specification Test Results

• Food GMP Manufactured Product:
• Meets U.S.P Requirements:
• GMP Manufactured Product:
• Meets F.C.C. Requirements:
• Preserve in Tight Containers:
• CAUTION: For Manufacturing, processing or repackaging:
• Bulk Food Chemical:
• Bulk Pharmaceutical Chemical:
• USP - Assay (as C₆H₈O₇) (calculated on anhydrous basis):
  99.5 - 100.5 %
• USP - Clarity of Solution:
  Passes Test
• USP - Color of Solution:
  Passes Test
• USP - Identification (USP):
  Passes Test
• USP - Water (H₂O) (U.S.P.):
  7.5 - 9.0 %
• USP - Residue on Ignition:
  ≤0.05 %
• USP - Oxalic Acid (USP):
  ≤0.036 %
• USP - Sulfate (SO₄):
  ≤0.015 %
• USP - Readily Carbonizable Substances:
  Passes Test
• FCC - Assay (as C₆H₈O₇) (calculated on anhydrous basis):
  99.5 - 100.5 %
• FCC - Identification (FCC):
  Passes Test
• FCC - Water (H₂O) (F.C.C.):
  ≤8.8 %
• FCC - Residue on Ignition:
  ≤0.05 %
• FCC - Oxalate (C₂O₄) (FCC):
  ≤100 mg/kg
• FCC - Readily Carbonizable Substances:
  Passes Test
• FCC - Lead (Pb):
  ≤0.5 mg/kg
• Appearance (white, crystalline powder):
  Passes Test
• Must be subjected to further processing during the preparation of:
• injectable dosage forms.:
• No Class 1,2,3 or other solvents are used or produced in the:
• manufacturing or purification of the product.:
• Elemental Impurities (USP 232) - Information on elemental impurities for:
• this product is available on the associated Product Regulatory Data:
• Sheet and elemental impurity profile report.:
• J.T.Baker®, Citric acid monohydrate 99.5-100.5% (by anhydrous basis) USP, FCC: