Magnesium stearate (vegetable based), Hyqual® (NF - GenAR®) FCC, NF, Macron Fine Chemicals™
Supplier: Avantor Performance Materials
Management of Change (MOC) category = R
2257-26EA
7414.87
EUR
2257-26
2257-88
2257-06
Magnesium stearate (vegetable based), Hyqual® (NF - GenAR®) FCC, NF, Macron Fine Chemicals™
Magnesium stearate
Food GMP Manufactured Product
GMP Manufactured Product
Meets B.P. Chemical Specifications
Meets ChP 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
Formula:
C₃₆H₇₀MgO₄ MW: 591,25 g/mol Melting Pt: 130…140 °C Density: 1,03 g/cm³ (20 °C) Storage Temperature: Ambient |
MDL Number:
MFCD00036391 CAS Number: 557-04-0 EINECS: 209-150-3 Merck Index: 13,05714 |
Specification Test Results
Food GMP Manufactured Product | |
Meets N.F. Requirements | |
Meets E.P. Chemical Specifications | |
Meets J.P. Chemical Specifications | |
GMP Manufactured Product | |
Meets ChP Chemical Specifications | |
Meets B.P. Chemical Specifications | |
Meets F.C.C. Requirements | |
CAUTION: For Manufacturing, processing or repackaging | |
Bulk Pharmaceutical Chemical | |
Bulk Food 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 |
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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