Specification Test Results

• ChP - Identification 1:
  Passes Test
• ChP - Identification 2:
  Passes Test
• ChP - Acidity or Alkalinity:
  Passes Test
• ChP - Chlorides (Cl):
  ≤ 0.10 %
• ChP - Sulfates (SO₄):
  ≤ 0.6 %
• ChP - Loss on Drying @ 80° C:
  ≤ 5.0 %
• ChP - Iron (Fe):
  ≤ 0.01 %
• ChP - Cadmium (Cd):
  ≤ 0.0003 %
• ChP - Nickel (Ni):
  ≤ 0.0005 %
• ChP - Stearic Acid:
  ≥ 40.0 %
• ChP - Heavy metals:
  ≤ 0.001 %
• ChP - Stearic and Palmitic Acids:
  ≥ 90.0 %
• ChP - Total Aerobic Microbial Count:
  ≤ 1000 cfu/g
• ChP - Total Yeast and Mold:
  ≤ 100 cfu/g
• ChP - Salmonella:
  None Detected
• ChP - Escherichia Coli:
  None Detected
• ChP - Assay (as Mg) (dried basis):
  4.0 - 5.0 %
• Food GMP Manufactured Product:
  —
• Meets N.F. Requirements:
  —
• Meets E.P. Chemical Specifications:
  —
• Meets J.P. Chemical Specifications:
  4.0 - 5.0 %
• GMP Manufactured Product:
  ≥ 40 %
• Meets ChP Chemical Specifications:
  ≥ 90 %
• Meets B.P. Chemical Specifications:
  Passes Test
• Meets F.C.C. Requirements:
  Passes Test
• CAUTION: For Manufacturing, processing or repackaging:
  Passes Test
• Bulk Pharmaceutical Chemical:
  Passes Test
• Bulk Food Chemical:
  ≤ 1000
• NF - Assay (as as Mg) (dried basis):
  4.0 - 5.0 %
• NF - Stearic Acid:
  ≥ 40 %
• NF - Stearic and Palmitic Acids:
  ≥ 90 %
• NF - Identification A:
  Passes Test
• NF - Identification B:
  Passes Test
• NF - Acidity or Alkalinity:
  Passes Test
• NF - Microbiological:
  Passes Test
• NF - Total Aerobic Microbial Count (cfu/g):
  ≤ 1000
• NF - Total Mold and Yeast Count (cfu/g):
  ≤ 500
• NF - Salmonella Species (negative):
  Passes Test
• NF - Escherichia Coli (negative):
  Passes Test
• NF - Loss on Drying at 105°C:
  ≤ 6.0 %
• Specific Surface Area, m²/g:
  5.0 - 10.0
• NF - Limit of Chloride:
  ≤ 0.1 %
• NF - Limit of Sulfate:
  ≤ 1.0 %
• NF - Cadmium (Cd):
  ≤ 3 ppm
• NF - Lead (Pb):
  ≤ 10 ppm
• NF - Nickel (Ni):
  ≤ 5 ppm
• EP/BP - Identification C:
  Passes Test
• EP/BP - Identification D:
  Passes Test
• EP/BP - Acidity or Alkalinity:
  Passes Test
• EP/ BP - Chloride (Cl):
  ≤ 0.1 %
• EP/BP - Sulfate (SO₄):
  ≤ 1.0 %
• EP/BP - Cadmium (Cd):
  ≤ 3 ppm
• EP/BP - Lead (Pb):
  ≤ 10 ppm
• EP/BP - Nickel (Ni):
  ≤ 5 ppm
• EP/BP - Loss on Drying at 105°C:
  ≤ 6.0 %
• Total Aerobic Microbial Count (cfu/g):
  ≤ 1000
• Escherichia Coli (negative):
  Passes Test
• EP/BP - Assay (as as Mg) (dried basis):
  4.0 - 5.0 %
• Salmonella (absent):
  Passes Test
• EP/BP - Stearic Acid:
  ≥ 40.0 %
• EP/BP - Stearic and Palmitic Acids:
  ≥ 90.0 %
• Total Mold and Yeast Count (cfu/g):
  ≤ 100
• JP - Identification:
  Passes Test
• JP - Acidity or Alkalinity:
  Passes Test
• JP - Chloride (Cl):
  ≤ 0.1 %
• JP - Sulfate (SO₄):
  ≤ 1.0 %
• JP - Heavy Metals (as Pb):
  ≤ 20 ppm
• JP - Stearic Acid:
  ≥ 40 %
• JP - Stearic and Palmitic Acids:
  ≥ 90 %
• JP - Loss on Drying at 105°C:
  ≤ 6.0 %
• JP - Microbiological:
  Passes Test
• JP - Total Aerobic Microbial Count (cfu/g):
  ≤ 1000
• JP - Total Mold and Yeast Count (cfu/g):
  ≤ 500
• JP - Salmonella Species (negative):
  Passes Test
• JP - Escherichia Coli (negative):
  Passes Test
• JP - Assay (as as Mg) (dried basis):
  4.0 - 5.0 %
• FCC - Identification A:
  Passes Test
• FCC - Identification B:
  Passes Test
• FCC - Assay (as MgO):
  6.8 - 8.3 %
• FCC - Lead (Pb):
  ≤ 5 mg/kg
• FCC - Loss on Drying at 105°C:
  ≤ 4.0 %
• Thru U.S. No. 325 Sieve, For Information Only:
  ≤ 0.10 %
• Tapped Density (g/cc):
  0.21 - 0.33
• Apparent (Bulk) Density:
  0.07 - 0.17 g/cm3
• Particle Size (50th percentile) (µm):
  10.5 - 16.5
• Particle Size (90th percentile) (µm):
  ≤ 35