Résultats des tests de spécification
Meets N.F. Requirements |
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Meets ChP Chemical Specifications |
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Meets B.P. Chemical Specifications |
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Meets E.P. Chemical Specifications |
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Meets J.P. Chemical Specifications |
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GMP Manufactured Product |
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CAUTION: For Manufacturing, processing or repackaging |
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Bulk Pharmaceutical Chemical |
4.0 - 5.0 % |
NF - Assay (as as Mg) (dried basis) |
4.0 - 5.0 % |
NF - Stearic Acid |
≥ 40.0 % |
NF - Stearic and Palmitic Acids |
≥ 90.0 % |
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 |
≤ 100 cfu/g |
NF - Salmonella Species (negative) |
Passes Test |
NF - Escherichia Coli (negative) |
Passes Test |
NF - Loss on Drying at 105°C |
≤ 4.0 % |
Specific Surface Area, m²/g |
6.0 - 12.0 |
NF - Limit of Chloride |
≤ 0.025 % |
NF - Limit of Sulfate |
≤ 0.5 % |
NF - Cadmium (Cd) |
≤ 3 ppm |
NF - Lead (Pb) |
≤ 10 ppm |
NF - Nickel (Ni) |
≤ 5 ppm |
EP/BP - Identification C (Major Peak) |
Passes Test |
EP/BP - Identification B (Acid Value) |
195 - 210 |
EP/BP - Identification D (Magnesium) |
Passes Test |
EP/BP - Acidity or Alkalinity |
Passes Test |
Chloride (Cl) |
≤ 0.025 % |
EP/BP - Sulfate (SO₄) |
≤ 0.5 % |
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 |
≤ 4.0 % |
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 Aerobic Microbial Count (cfu/g) |
≤ 1000 |
Total Mold and Yeast Count (cfu/g) |
≤ 100 |
JP - Identification |
Passes Test |
JP - Acidity or Alkalinity |
Passes Test |
JP - Chloride (Cl) |
≤ 0.025 % |
JP - Sulfate (SO₄) |
≤ 0.5 % |
JP - Heavy Metals (as Pb) |
≤ 20 ppm |
JP - Stearic Acid |
≥ 40.0 % |
JP - Stearic and Palmitic Acids |
≥ 90.0 % |
JP - Loss on Drying at 105°C |
≤ 4.0 % |
JP - Microbiological |
Passes Test |
JP - Total Aerobic Microbial Count (cfu/g) |
≤ 1000 |
JP - Total Mold and Yeast Count |
≤ 100 cfu/g |
JP - Salmonella Species (negative) |
Passes Test |
JP - Escherichia Coli (negative) |
Passes Test |
JP - Assay (as as Mg) (dried basis) |
4.0 - 5.0 % |
Appearance (Fine white powder) |
Passes Test |
Particle Size 90th Percentile |
≤ 35 µm |
Particle Size 50th Percentile |
6.0 - 14.0 µm |
Sieve Test US Standard No. 325 - % Thru |
≥ 99.5 % |
Apparent Density |
0.07 - 0.17 g/cm3 |
Tapped Density |
0.18 - 0.33 g/cm3 |
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 |
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manufacturing or purification of the product. |
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Fatty acids are derived from edible sources. |
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