Spezifikation Testergebnisse
Food GMP Manufactured Product |
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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 |
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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