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

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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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