TEST |
SPECIFICATION |
Food GMP Manufactured Product |
GMP Manufactured Product |
Meets B.P. Chemical Specifications |
Meets E.P. Chemical Specifications |
Meets F.C.C. Requirements |
Meets J.P. Chemical Specifications |
Meets N.F. Requirements |
CAUTION: For Manufacturing, processing or repackaging |
Bulk Food Chemical |
Bulk Pharmaceutical 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 |
No Class 1,2,3 or other solvents are used or produced in the manufacturing or purification of the product. |