Magnesium stearate (vegetable based), Hyqual® NF - GenAR® NF, Macron Fine Chemicals™
Supplier: Avantor Performance Materials
|
Warning
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Management of Change (MOC) category = R
5712-06EA
46286.28
INR
5712-06
5712-26
5712-88
Magnesium stearate (vegetable based), Hyqual® NF - GenAR® NF, Macron Fine Chemicals™
Magnesium stearate
Caution: For Manufacturing, processing or repackaging
|
Formula:
C₃₆H₇₀MgO₄ 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
| 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 | 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 | |
| manufacturing or purification of the product. | |
| Fatty acids are derived from edible sources. |
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