Magnesium stearate (vegetable based), Hyqual® (NF - GenAR®) FCC, NF, Macron Fine Chemicals™
Supplier: Avantor Performance Materials
Synonyms:
Stearic acid Magnesium(II) salt, Magnesium(II) Stearate, Stearic acid magnesium salt
2257-88EA
137673.25
INR
2257-88
2257-26
2257-06
Magnesium stearate (vegetable based), Hyqual® (NF - GenAR®) FCC, NF, Macron Fine Chemicals™
Magnesium stearate
Formula:
C₃₆H₇₀MgO₄ MW: 591,25 g/mol |
MDL Number:
MFCD00036391 CAS Number: 557-04-0 |
Specification Test Results
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 |
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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