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Magnesium Stearate NF 12Kg BP FCC
2257/88-12Kg



Specification Test Results

Food GMP Manufactured Product  
Meets N.F. Requirements  
Meets E.P. Chemical Specifications  
Meets J.P. Chemical Specifications  
GMP Manufactured Product  
Meets ChP Chemical Specifications  
Meets B.P. Chemical Specifications  
Meets F.C.C. Requirements  
CAUTION: For Manufacturing, processing or repackaging  
Bulk Pharmaceutical Chemical  
Bulk Food Chemical  
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  
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
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 - Heavy metals ≤ 0.001 %
ChP - Stearic Acid ≥ 40.0 %
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 %
No Class 1,2,3 or other solvents are used or produced in the manufacturing or purification of the product.  

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