Magnesium stearate (vegetable based), Hyqual® NF - GenAR® NF, Macron Fine Chemicals™

Supplier: Avantor Performance Materials


Management of Change (MOC) category = R

5712-26EA 7471.03 EUR
5712-26 5712-88 5712-06
Magnesium stearate (vegetable based), Hyqual® NF - GenAR® NF, Macron Fine Chemicals™
Magnesium stearate

Upozornení: For Manufacturing, processing or repackaging

Formula: C₃₆H₇₀MgO₄
MW: 591,25 g/mol
Melting Pt: 130…140 °C
Density: 1,03 g/cm³ (20 °C)
MDL Number: MFCD00036391
CAS Number: 557-04-0
Merck Index: 13,05714

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Specification Test Results

Meets N.F. Requirements
Meets ChP Chemical Specifications
Meets B.P. Chemical Specifications
Meets E.P. Chemical Specifications
Meets J.P. Chemical Specifications
GMP Manufactured Product
CAUTION: For Manufacturing, processing or repackaging
Bulk Pharmaceutical Chemical
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
manufacturing or purification of the product.
Fatty acids are derived from edible sources.

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